<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03011450</url>
  </required_header>
  <id_info>
    <org_study_id>K-877-303</org_study_id>
    <nct_id>NCT03011450</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment</brief_title>
  <official_title>A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and &lt;2000 mg/dL and Mild or Moderate Renal Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kowa Research Institute, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kowa Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients&#xD;
      With Fasting High Triglyceride Levels ≥500 mg/dL and &lt;2000 mg/dL and Mild or Moderate Renal&#xD;
      Impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2016</start_date>
  <completion_date type="Actual">July 5, 2019</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Fasting TG From Baseline to Week 12</measure>
    <time_frame>12 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Remnant Cholesterol</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in HDL-C</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo A1</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Non-HDL-C</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Total Cholesterol</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in LDL-C</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in FFAs</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo A2</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo B</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo B48</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo B100</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo C2</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo C3</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apo E</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in FGF21</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in hsCRP</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles)</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles-Large)</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Triglyceride)</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Fasting TG</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Remnant Cholesterol</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in HDL-C</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo A1</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Non-HDL-C</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in TC</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in LDL-C</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in FFAs</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo A2</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo B</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo B48</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo B100</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo C2</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo C3</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Apo E</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in FGF21</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in hsCRP</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles)</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles-Large)</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Triglyceride)</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2</measure>
    <time_frame>52 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">471</enrollment>
  <condition>Severe Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>12 Week Efficacy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>K-877 or placebo comparator for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40 week extension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>K-877 or fenofibrate comparator for 40 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>K-877</intervention_name>
    <arm_group_label>12 Week Efficacy</arm_group_label>
    <arm_group_label>40 week extension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate</intervention_name>
    <arm_group_label>40 week extension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (for K-877)</intervention_name>
    <arm_group_label>12 Week Efficacy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to understand and willing to comply with all study requirements and procedures&#xD;
             throughout the duration of the study and give written informed consent;&#xD;
&#xD;
          2. Aged ≥18 years;&#xD;
&#xD;
          3. Patients receiving moderate- or high-intensity statin therapy must meet one of the&#xD;
             following criteria¹ unless they have any exceptional conditions (see inclusion&#xD;
             criterion 4):&#xD;
&#xD;
               1. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD)&#xD;
                  (history of acute coronary syndrome or myocardial infarction, stable or unstable&#xD;
                  angina, coronary or other arterial revascularization, stroke, transient ischemic&#xD;
                  attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial&#xD;
                  disease or revascularization), on a high-intensity statin (or moderate-intensity&#xD;
                  statin if not a candidate for high-intensity statin due to safety concerns);&#xD;
&#xD;
               2. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary&#xD;
                  modifiable causes, on a high-intensity statin (or moderate-intensity statin if&#xD;
                  not a candidate for high-intensity statin due to safety concerns);&#xD;
&#xD;
               3. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a&#xD;
                  history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity&#xD;
                  statin; or&#xD;
&#xD;
               4. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a&#xD;
                  history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for&#xD;
                  ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity&#xD;
                  statin;&#xD;
&#xD;
          4. Patients currently on a low-intensity statin or not on a statin, must meet one of the&#xD;
             following criteria;&#xD;
&#xD;
               1. Patient does not meet any criteria for moderate- or high-intensity statin therapy&#xD;
                  listed above (see inclusion criteria, 3.a. through 3.d.);&#xD;
&#xD;
               2. Patient does meet one or more criteria for moderate- or high-intensity statin&#xD;
                  therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient&#xD;
                  is not a candidate for moderate or high-intensity statin due to safety concerns,&#xD;
                  or due to partial or complete statin intolerance; or&#xD;
&#xD;
               3. Patient does meet one or more criteria for moderate- or high intensity statin&#xD;
                  therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.);&#xD;
                  but the patient is not a candidate for moderate or high intensity statin for&#xD;
                  primary prevention after considering individual risk evaluation (e.g. current LDL&#xD;
                  C ≤70mg/dL) and patient preference;&#xD;
&#xD;
          5. Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and &lt;2000 mg/dL (22.60 mmol/L) based on the&#xD;
             mean of Visit 2 (Week -2) and Visit 3 (Week -1).&#xD;
&#xD;
               -  Mild to moderate renal impairment eGFR &gt;= 30mL/min/1.73 and &lt; 90 mL/min/1.73 at&#xD;
                  Visit 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who will require lipid-altering treatments other than study drugs (K-877 or&#xD;
             fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study.&#xD;
             These include bile acid sequestrants, non-study fibrates, niacin (&gt;100 mg/day),&#xD;
             omega-3 fatty acids (&gt;1000 mg/day), or any supplements used to alter lipid metabolism&#xD;
             including, but not limited to, red rice yeast supplements, garlic supplements, soy&#xD;
             isoflavone supplements, sterol/stanol products, or policosanols;&#xD;
&#xD;
          2. Body mass index (BMI) &gt;45 kg/m2 at Visit 1 (Week -8 or Week -6);&#xD;
&#xD;
          3. Patients with type 1 diabetes mellitus;&#xD;
&#xD;
          4. Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly&#xD;
             controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c &gt;9.5% at Visit 1&#xD;
             (Week -8 or Week -6);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Central Research Associates, Inc.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Alabama Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cahaba Research, Inc.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boyett Health Services Inc</name>
      <address>
        <city>Hamilton</city>
        <state>Alabama</state>
        <zip>35570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longwood Research - Saadat Ansari, MD, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terence T. Hart, MD</name>
      <address>
        <city>Tuscumbia</city>
        <state>Alabama</state>
        <zip>35674</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrowhead Health Centers</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Medical Research Institute, LLC</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Arizona, LLC</name>
      <address>
        <city>Surprise</city>
        <state>Arizona</state>
        <zip>85374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of the Ozarks</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Center</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research Institute Inc.</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Downtown L.A. Research Center, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catalina Research Institute, LLC</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Coast Cardiology and Research</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lucita M. Cruz, MD., Inc.</name>
      <address>
        <city>Norwalk</city>
        <state>California</state>
        <zip>90650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrated Research Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimus Medical Group</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creekside Endocrine Associates, PC</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Clinical Research Collaborative</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ALL Medical Research, LLC</name>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S &amp; W Clinical Research</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indago Research and Health Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Impotence Treatment Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMPM Research Clinic</name>
      <address>
        <city>Miami Gardens</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute Inc</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocala Cardiovascular Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34474</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Research Solutions LLC.</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Center of Sarasota</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research - Tampa</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Health</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians Research Associates, Inc</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Institute for Clinical Research</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrine Research Solutions, Inc</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research - Savannah, GA</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solaris Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lemah Creek Clinical Research</name>
      <address>
        <city>Burr Ridge</city>
        <state>Illinois</state>
        <zip>60527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedar-Crosse Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Medical Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koch Family Medicine</name>
      <address>
        <city>Morton</city>
        <state>Illinois</state>
        <zip>61550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital of Anderson and Madison County, Inc</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network - Avon Clinical Research Department</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisphere Medical Research Center</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Institute for Clinical Research</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buynak Clinical Research, P.C.</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Broadway Clinic</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Iowa Clinic - Cardiovascular Services</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Professional Research Network of Kansas, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Diabetes Endocrinology Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Group of Lexington, LLC</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Integrity LLC</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC - Northshore</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management LLC - Southshore</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grace Research, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America, LLC</name>
      <address>
        <city>West Monroe</city>
        <state>Louisiana</state>
        <zip>71291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Cardiovascular Specialists</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneris Medical</name>
      <address>
        <city>North Attleboro</city>
        <state>Massachusetts</state>
        <zip>2760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aa Mrc, Llc</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakland Medical Research Center</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David M. Headley, MD P.A.</name>
      <address>
        <city>Port Gibson</city>
        <state>Mississippi</state>
        <zip>39150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consult and Research Associates</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Clinical Research, Inc</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glacier View Research Institute</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Endocrinology Clinical Research Center</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Research Center, Inc.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lovelace Scientific Resources</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeshore Primary Care Associate</name>
      <address>
        <city>Hamburg</city>
        <state>New York</state>
        <zip>14075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Hudson Medical Research, PLLC - Hopewell Junction</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Hudson Medical Research, PLLC - New Windsor</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orchard Park Family Practice</name>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <zip>14127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Endocrinology Consultants, P.C.</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lillestol Research, LLC</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group, Ltd. - Auburn</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research, Inc.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpha Research Associates, LLC</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prestige Clinical Research</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Clinical Research - Lyndhurst</name>
      <address>
        <city>Lyndhurst</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rama Research LLC</name>
      <address>
        <city>Marion</city>
        <state>Ohio</state>
        <zip>43302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RAS Health Ltd</name>
      <address>
        <city>Marion</city>
        <state>Ohio</state>
        <zip>43302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Group, LLC</name>
      <address>
        <city>Munroe Falls</city>
        <state>Ohio</state>
        <zip>44626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Clinical Research, LLC - Willoughby Hills</name>
      <address>
        <city>Willoughby Hills</city>
        <state>Ohio</state>
        <zip>44094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COR Clinical Research, LLC.</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Oklahoma Heart Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates of Central PA, LLC</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harleysville Medical Associates</name>
      <address>
        <city>Harleysville</city>
        <state>Pennsylvania</state>
        <zip>19438</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richard M.Kastelic MD and Associates</name>
      <address>
        <city>Johnstown</city>
        <state>Pennsylvania</state>
        <zip>15905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green and Seidner Family Practice Associates</name>
      <address>
        <city>Lansdale</city>
        <state>Pennsylvania</state>
        <zip>19446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Medical Research, LLC</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>2908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD First Research</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MDFirst Research - Anderson</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DeGarmo Institute Of Medical Research</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD First Research</name>
      <address>
        <city>Lancaster</city>
        <state>South Carolina</state>
        <zip>29720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine of SayeBrook</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Concepts</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Bristol, LLC - State</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chattanooga Research &amp; Medicine, PLLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Phase Research &amp; Development</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions - Smyrna, TN</name>
      <address>
        <city>Smyrna</city>
        <state>Tennessee</state>
        <zip>37167</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Innovation Research Group</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCT-AACT, LLC, dba Discovery Clinical Trials</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inquest Clinical Research</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Padre Coast Clinical Research</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protenium Clinical Research, LLC - Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academy of Diabetes, Thyroid and Endocrine, P.A.</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juno Research, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juno Research, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grace Research, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Texas</state>
        <zip>77340</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protenium Clinical Research, LLC</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juno Research, LLC</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FMC Science</name>
      <address>
        <city>Lampasas</city>
        <state>Texas</state>
        <zip>76550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Clinical Research</name>
      <address>
        <city>Live Oak</city>
        <state>Texas</state>
        <zip>78233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCT - McAllen Primary Care, LLC</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Premier Internal Medicine</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bandera Family HealthCare Research, LLC (BFHC)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manassas Clinical Research Center</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Clinical Research LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Associates, Ltd</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exemplar Research Inc. - Fairmont, WV</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegiance Research Specialists, LLC</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brest Regional Hospital</name>
      <address>
        <city>Brest</city>
        <zip>224027</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gomel Regional Clinical Hospital</name>
      <address>
        <city>Gomel</city>
        <zip>246029</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gomel Regional Clinical Center of Cardiology</name>
      <address>
        <city>Gomel</city>
        <zip>246046</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grodno University Hospital</name>
      <address>
        <city>Grodno</city>
        <zip>230030</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #1</name>
      <address>
        <city>Minsk</city>
        <zip>220013</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #9</name>
      <address>
        <city>Minsk</city>
        <zip>220045</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology</name>
      <address>
        <city>Minsk</city>
        <zip>220045</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #10</name>
      <address>
        <city>Minsk</city>
        <zip>220096</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minsk Regional Clinical Hospital</name>
      <address>
        <city>Minsk</city>
        <zip>223041</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mogilev Regional Medical and Diagnostic Center</name>
      <address>
        <city>Mogilev</city>
        <zip>212030</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitebsk Regional Clinical Hospital</name>
      <address>
        <city>Vitebsk</city>
        <zip>210037</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Diamedical 2013 OOD</name>
      <address>
        <city>Dimitrovgrad</city>
        <zip>6400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - Clinic of Cardiology</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dr. Bratan Shukjerov</name>
      <address>
        <city>Smolyan</city>
        <zip>4700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD</name>
      <address>
        <city>Smolyan</city>
        <zip>4700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Orfey OOD</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicus Services SRO</name>
      <address>
        <city>Brandýs nad Labem</city>
        <zip>250 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lipidova poradna</name>
      <address>
        <city>Bílina</city>
        <zip>41801</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka</name>
      <address>
        <city>Hradec Králové</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace pro choroby srdce a cev</name>
      <address>
        <city>Praha 10</city>
        <zip>101 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze</name>
      <address>
        <city>Praha 2</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice v Motole</name>
      <address>
        <city>Praha 5</city>
        <zip>15006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie</name>
      <address>
        <city>Trutnov</city>
        <zip>541 21</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUDr. Nina Zemkova s.r.o. Interni Ambulance</name>
      <address>
        <city>Uherské Hradište</city>
        <zip>68601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unimed Ajara LLC</name>
      <address>
        <city>Batumi</city>
        <zip>6010</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic LJ Ltd</name>
      <address>
        <city>Kutaisi</city>
        <zip>4600</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aleksandre Aladashvili Clinic - LLC</name>
      <address>
        <city>Tbilisi</city>
        <zip>102</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Archangel St Michael Multiprofile Clinical Hospital Ltd</name>
      <address>
        <city>Tbilisi</city>
        <zip>159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Cardiology Center by Academician G. Chapidze Ltd</name>
      <address>
        <city>Tbilisi</city>
        <zip>159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Clinical Cardiology Ltd</name>
      <address>
        <city>Tbilisi</city>
        <zip>159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unimed Kakheti - Caraps Medline LLC</name>
      <address>
        <city>Tbilisi</city>
        <zip>159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unimed Kakheti - Telavi Referral Hospital LLC</name>
      <address>
        <city>Telavi</city>
        <zip>2200</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRC Gyogyszervizsgalo Kozpont Kft</name>
      <address>
        <city>Balatonfüred</city>
        <zip>H-8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRC Balatongyorok</name>
      <address>
        <city>Balatongyörök</city>
        <zip>H-8313</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvedseg Egeszsegugyi Kozpont</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo</name>
      <address>
        <city>Békéscsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>H-4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BKS Research Kft.</name>
      <address>
        <city>Hatvan</city>
        <zip>3000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika</name>
      <address>
        <city>Pécs</city>
        <zip>7624</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz</name>
      <address>
        <city>Székesfehérvár</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman</name>
      <address>
        <city>Gdynia</city>
        <zip>81-157</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SALVIA Lekston i Madej s.j.</name>
      <address>
        <city>Katowice</city>
        <zip>40-772</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O</name>
      <address>
        <city>Krakow</city>
        <zip>31-534</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDICOME Sp. z o.o.</name>
      <address>
        <city>Oświęcim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia Metabolicznego Pawel Bogdanski</name>
      <address>
        <city>Poznań</city>
        <zip>60-589</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praktyka Lekarska Ewa Krzyzagorska</name>
      <address>
        <city>Poznań</city>
        <zip>61-655</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O</name>
      <address>
        <city>Płock</city>
        <zip>09-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinmedica Research Omc Sp z o.o. Sp</name>
      <address>
        <city>Skierniewice</city>
        <zip>96-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Kardiologiczne Pro Corde Sp. z o. o.</name>
      <address>
        <city>Wrocław</city>
        <zip>50-315</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AppleTreeClinics Sp. z o.o.</name>
      <address>
        <city>Łódź</city>
        <zip>90-349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Salusmed</name>
      <address>
        <city>Łódź</city>
        <zip>91 302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek</name>
      <address>
        <city>Łódź</city>
        <zip>94-048</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First City Clinical Hospital n.a. E.E.Volosevich</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163001</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction</name>
      <address>
        <city>Barnaul</city>
        <zip>656055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chita State Medical Academy</name>
      <address>
        <city>Chita</city>
        <zip>672000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interregional Clinical Diagnostic Center</name>
      <address>
        <city>Kazan</city>
        <zip>420101</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical University based at City Clinical Hospital #7</name>
      <address>
        <city>Kazan</city>
        <zip>420103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budget Institution &quot;Scientific-Research Institute of Complex Problems of Cardiovascular Diseases</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Alliance</name>
      <address>
        <city>Kirovsk</city>
        <zip>187342</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Research Center of Preventive Medicine</name>
      <address>
        <city>Moscow</city>
        <zip>101990</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #15 n.a. O.M. Filatov</name>
      <address>
        <city>Moscow</city>
        <zip>111539</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Clinical Hospital of Russian Academy of Sciences</name>
      <address>
        <city>Moscow</city>
        <zip>117593</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department</name>
      <address>
        <city>Moscow</city>
        <zip>121374</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Research Center of Cardiology - Department of Atherosclerosis</name>
      <address>
        <city>Moscow</city>
        <zip>121552</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Research Center of Cardiology</name>
      <address>
        <city>Moscow</city>
        <zip>121552</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital n.a. M.P. Konchalovskiy</name>
      <address>
        <city>Moscow</city>
        <zip>124489</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Non-governmental Private Healthcare Institution &quot;Scientific Clinical Centre of Open Joint-Stock Company Russian Railways&quot; (JSC &quot;RZD&quot;)</name>
      <address>
        <city>Moscow</city>
        <zip>125315</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budget Institution &quot;Outpatient Clinic #3&quot; of Russian Federation President's Management Department</name>
      <address>
        <city>Moscow</city>
        <zip>129090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital No.2</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630051</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RC Medical LLC</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Physiology and Fundamental Medicine</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630117</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orenburg State Medical University based at City Clinical Hospital #1</name>
      <address>
        <city>Orenburg</city>
        <zip>460000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical-diagnostic center Zdorovye</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov-on-Don City Hospital of Emergency Care</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Complex JSC</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>190013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North-Western State Medical University named after I.I. Mechnikov</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Technologies LLC</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191025</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company MedPomosch</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City hospital #38 n.a. N.A. Semashko</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196601</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioTechService LLC</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultative Diagnostic Center with Out-patient Clinic</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg State Budget Healthcare Institution &quot;City Pokrovskaya Hospital&quot;, Department of Cardiology N.3</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>199106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Cardiology Dispensary</name>
      <address>
        <city>Saratov</city>
        <zip>410028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov State Medical University n. a. V.I. Razumovsky</name>
      <address>
        <city>Saratov</city>
        <zip>410054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Almazov National Medical Research Centre</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194156</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomsk National Research Medical Center of Russian Academy of Sciences</name>
      <address>
        <city>Tomsk</city>
        <zip>634012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Autonomous Institution of healthcare of the Voronezh region &quot;Voronezh regional clinical consultative and diagnostic centre</name>
      <address>
        <city>Voronezh</city>
        <zip>394018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly &quot;Zdorovoe Dolgoletie&quot;</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department</name>
      <address>
        <city>Kharkiv</city>
        <zip>61002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kharkiv Medical Academy of Postgraduate Education</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kharkiv Railway Clinic. Hosp.#1, Branch Office of &quot;Healthcare Center&quot; of PJSC &quot;Ukr. Railways&quot;, Cardiology Depart #2</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-Commercial Enterprise &quot;City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov of Kharkiv City Council</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1</name>
      <address>
        <city>Kharkiv</city>
        <zip>61172</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company Treatment and Diagnostic Center Adonis Plus, Outpatient Department</name>
      <address>
        <city>Kyiv</city>
        <zip>2002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Hospital #1, Urgent Cardiology Department</name>
      <address>
        <city>Kyiv</city>
        <zip>2091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t., Gen. Ther.Unit</name>
      <address>
        <city>Kyiv</city>
        <zip>4114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t</name>
      <address>
        <city>Kyiv</city>
        <zip>4114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution City Clinical Hospital #3 n.a. prof. L.J. Aleinikova, Cardiology Intensive Therapy Department</name>
      <address>
        <city>Odesa</city>
        <zip>65014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Small Private Enterprise, Medical Centre Puls</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution City Clinical Hospital #6, Therapeutic Department</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Georgia</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>June 8, 2022</results_first_submitted>
  <results_first_submitted_qc>September 30, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2022</results_first_posted>
  <disposition_first_submitted>April 22, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>April 27, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 1, 2020</disposition_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertriglyceridemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fenofibrate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Ver.1.0</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03011450/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Ver.2.0</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03011450/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: V1.0</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03011450/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: V2.0</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03011450/SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Addendum</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03011450/SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Eligible patients entered a 4- to 6-week lifestyle stabilization period. The stabilization period was followed by a 2-week TG qualifying period, and patient eligibility was assessed based on the mean TG value from these 2 visits. If the patient's mean TG level during the TG qualifying period was ≥450 mg/dL (5.09 mmol/L) and &lt;500 mg/dL (5.65 mmol/L), an additional TG measurement was taken 1 week later at Visit 3.1. The mean of all 3 TG measurements was used to determine eligibility for the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>K-877</title>
          <description>Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets BID in the 40-week Extension Period</description>
        </group>
        <group group_id="P2">
          <title>Placebo/Fenofibrate</title>
          <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>12-week Efficacy</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="311"/>
                <participants group_id="P2" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="299"/>
                <participants group_id="P2" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>40-week Extension</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="292"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="275"/>
                <participants group_id="P2" count="146"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One participant was randomized but not assigned to a treatment group per physician decision</population>
      <group_list>
        <group group_id="B1">
          <title>K-877</title>
          <description>K-877 0.2 mg Tablets</description>
        </group>
        <group group_id="B2">
          <title>Placebo/Fenofibrate</title>
          <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="311"/>
            <count group_id="B2" value="159"/>
            <count group_id="B3" value="470"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="220"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="299"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported/unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="793.44" spread="390.102"/>
                    <measurement group_id="B2" value="759.36" spread="395.359"/>
                    <measurement group_id="B3" value="781.45" spread="391.511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Fasting TG From Baseline to Week 12</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Fasting TG From Baseline to Week 12</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-58.89" lower_limit="-71.69" upper_limit="-38.42"/>
                    <measurement group_id="O2" value="-22.94" lower_limit="-43.98" upper_limit="9.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Remnant Cholesterol</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Remnant Cholesterol</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.51" lower_limit="-71.29" upper_limit="-33.64"/>
                    <measurement group_id="O2" value="-13.29" lower_limit="-43.30" upper_limit="9.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in HDL-C</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.50" lower_limit="5.24" upper_limit="45.13"/>
                    <measurement group_id="O2" value="7.33" lower_limit="-4.00" upper_limit="18.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo A1</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo A1</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.05" lower_limit="-5.57" upper_limit="14.62"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-7.80" upper_limit="10.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0156</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Non-HDL-C</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Non-HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.98" lower_limit="-34.70" upper_limit="-4.06"/>
                    <measurement group_id="O2" value="-3.43" lower_limit="-23.66" upper_limit="6.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Total Cholesterol</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Total Cholesterol</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.55" lower_limit="-25.74" upper_limit="-1.19"/>
                    <measurement group_id="O2" value="-2.05" lower_limit="-17.59" upper_limit="7.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in LDL-C</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in LDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.49" lower_limit="0.65" upper_limit="72.06"/>
                    <measurement group_id="O2" value="2.30" lower_limit="-14.50" upper_limit="23.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in FFAs</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in FFAs</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="303"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.25" lower_limit="-48.37" upper_limit="3.74"/>
                    <measurement group_id="O2" value="-5.51" lower_limit="-32.64" upper_limit="28.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo A2</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo A2</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.34" lower_limit="7.27" upper_limit="35.41"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-8.09" upper_limit="6.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo B</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo B</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" lower_limit="-14.90" upper_limit="16.66"/>
                    <measurement group_id="O2" value="-1.67" lower_limit="-11.71" upper_limit="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5380</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo B48</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo B48</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.64" lower_limit="-71.42" upper_limit="17.61"/>
                    <measurement group_id="O2" value="19.91" lower_limit="-18.96" upper_limit="101.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo B100</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo B100</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" lower_limit="-13.31" upper_limit="18.13"/>
                    <measurement group_id="O2" value="-2.33" lower_limit="-14.42" upper_limit="12.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1165</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo C2</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo C2</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.70" lower_limit="-27.33" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0142</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo C3</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo C3</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.97" lower_limit="-54.44" upper_limit="-21.64"/>
                    <measurement group_id="O2" value="-3.10" lower_limit="-25.16" upper_limit="18.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apo E</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apo E</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.09" lower_limit="-44.73" upper_limit="-6.92"/>
                    <measurement group_id="O2" value="-5.98" lower_limit="-28.29" upper_limit="12.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in FGF21</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in FGF21</title>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277.97" lower_limit="37.31" upper_limit="650.73"/>
                    <measurement group_id="O2" value="12.15" lower_limit="-162.80" upper_limit="112.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in hsCRP</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in hsCRP</title>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.201" lower_limit="-1.355" upper_limit="0.685"/>
                    <measurement group_id="O2" value="-0.100" lower_limit="-1.235" upper_limit="0.821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4589</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.45" lower_limit="-55.39" upper_limit="-5.31"/>
                    <measurement group_id="O2" value="-5.95" lower_limit="-27.52" upper_limit="30.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.23" lower_limit="-42.10" upper_limit="1.79"/>
                    <measurement group_id="O2" value="0.07" lower_limit="-18.32" upper_limit="25.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.07" lower_limit="-24.09" upper_limit="9.75"/>
                    <measurement group_id="O2" value="4.16" lower_limit="-12.56" upper_limit="21.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" lower_limit="-17.02" upper_limit="22.34"/>
                    <measurement group_id="O2" value="2.42" lower_limit="-9.70" upper_limit="17.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2486</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.52" lower_limit="-2.00" upper_limit="39.87"/>
                    <measurement group_id="O2" value="3.21" lower_limit="-9.58" upper_limit="17.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.20" lower_limit="10.67" upper_limit="89.89"/>
                    <measurement group_id="O2" value="4.81" lower_limit="-11.65" upper_limit="25.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.94" lower_limit="14.68" upper_limit="112.53"/>
                    <measurement group_id="O2" value="4.24" lower_limit="-16.31" upper_limit="23.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.44" lower_limit="8.96" upper_limit="110.09"/>
                    <measurement group_id="O2" value="1.89" lower_limit="-14.54" upper_limit="23.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.79" lower_limit="-19.17" upper_limit="76.61"/>
                    <measurement group_id="O2" value="-0.80" lower_limit="-13.28" upper_limit="17.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.73" lower_limit="-48.62" upper_limit="47.19"/>
                    <measurement group_id="O2" value="0.71" lower_limit="-21.79" upper_limit="16.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2763</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.48" lower_limit="-59.53" upper_limit="7.01"/>
                    <measurement group_id="O2" value="-2.89" lower_limit="-20.28" upper_limit="16.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.08" lower_limit="-54.14" upper_limit="-15.21"/>
                    <measurement group_id="O2" value="-0.74" lower_limit="-21.22" upper_limit="19.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.39" lower_limit="-38.34" upper_limit="-11.75"/>
                    <measurement group_id="O2" value="0.89" lower_limit="-15.75" upper_limit="15.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.65" lower_limit="-19.15" upper_limit="-0.88"/>
                    <measurement group_id="O2" value="0.91" lower_limit="-9.59" upper_limit="11.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)</title>
        <description>Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)</title>
          <description>Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.</description>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" lower_limit="-10.90" upper_limit="7.50"/>
                    <measurement group_id="O2" value="-0.53" lower_limit="-8.50" upper_limit="9.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1651</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" lower_limit="0.90" upper_limit="4.73"/>
                    <measurement group_id="O2" value="0.14" lower_limit="-0.60" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles)</title>
        <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles)</title>
          <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.76" lower_limit="-61.49" upper_limit="-15.41"/>
                    <measurement group_id="O2" value="-5.59" lower_limit="-29.00" upper_limit="24.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles-Large)</title>
        <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles-Large)</title>
          <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.62" lower_limit="-31.63" upper_limit="-3.27"/>
                    <measurement group_id="O2" value="-3.75" lower_limit="-18.37" upper_limit="8.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.27" lower_limit="-79.42" upper_limit="-9.78"/>
                    <measurement group_id="O2" value="-9.13" lower_limit="-36.78" upper_limit="26.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" lower_limit="-25.09" upper_limit="20.86"/>
                    <measurement group_id="O2" value="0.07" lower_limit="-16.80" upper_limit="20.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5107</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.58" lower_limit="-13.32" upper_limit="60.38"/>
                    <measurement group_id="O2" value="4.97" lower_limit="-15.42" upper_limit="25.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0018</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.06" lower_limit="-123.66" upper_limit="39.24"/>
                    <measurement group_id="O2" value="-2.74" lower_limit="-87.30" upper_limit="76.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0742</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.52" lower_limit="0.00" upper_limit="306.49"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-13.04" upper_limit="43.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.88" lower_limit="-254.52" upper_limit="394.98"/>
                    <measurement group_id="O2" value="12.43" lower_limit="-135.98" upper_limit="230.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2707</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" lower_limit="-8.43" upper_limit="23.02"/>
                    <measurement group_id="O2" value="-1.60" lower_limit="-13.63" upper_limit="11.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>µmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" lower_limit="-0.94" upper_limit="1.56"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-1.02" upper_limit="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2879</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>µmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" lower_limit="-3.98" upper_limit="2.90"/>
                    <measurement group_id="O2" value="-0.23" lower_limit="-2.96" upper_limit="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9786</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>µmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" lower_limit="-2.95" upper_limit="7.78"/>
                    <measurement group_id="O2" value="0.16" lower_limit="-4.19" upper_limit="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0075</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.02" lower_limit="-16.79" upper_limit="5.79"/>
                    <measurement group_id="O2" value="-2.26" lower_limit="-11.03" upper_limit="7.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0241</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="305"/>
                <count group_id="O2" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" lower_limit="0.00" upper_limit="3.54"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.53" upper_limit="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)</title>
          <units>Percent Change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.19" lower_limit="-4.48" upper_limit="2.36"/>
                    <measurement group_id="O2" value="-0.14" lower_limit="-3.22" upper_limit="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0502</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.86" lower_limit="-70.90" upper_limit="-31.38"/>
                    <measurement group_id="O2" value="-15.24" lower_limit="-37.36" upper_limit="18.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Triglyceride)</title>
        <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL &amp; Chylomicron Triglyceride)</title>
          <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.19" lower_limit="-70.80" upper_limit="-32.36"/>
                    <measurement group_id="O2" value="-16.20" lower_limit="-37.74" upper_limit="21.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)</title>
          <units>Percent Change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="305"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.51" lower_limit="-12.73" upper_limit="29.84"/>
                    <measurement group_id="O2" value="-2.20" lower_limit="-17.16" upper_limit="16.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0209</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-66.21" lower_limit="-79.82" upper_limit="-42.95"/>
                    <measurement group_id="O2" value="-26.81" lower_limit="-51.86" upper_limit="13.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.36" lower_limit="-47.83" upper_limit="-10.34"/>
                    <measurement group_id="O2" value="-9.02" lower_limit="-29.95" upper_limit="6.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.36" lower_limit="-47.83" upper_limit="-10.34"/>
                    <measurement group_id="O2" value="-9.02" lower_limit="-29.95" upper_limit="6.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B</title>
        <time_frame>12 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.</population>
          <units>Ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.219" lower_limit="0.050" upper_limit="0.359"/>
                    <measurement group_id="O2" value="0.026" lower_limit="-0.096" upper_limit="0.138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>non-parametric Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.68" lower_limit="-19.68" upper_limit="17.39"/>
                    <measurement group_id="O2" value="-1.25" lower_limit="-13.68" upper_limit="9.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2</title>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matching K-877 0.2 mg tablet BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.76" lower_limit="-45.35" upper_limit="-7.99"/>
                    <measurement group_id="O2" value="-0.47" lower_limit="-23.52" upper_limit="17.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Hodges-Lehmann method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Fasting TG</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Fasting TG</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-59.96" lower_limit="-74.38" upper_limit="-41.52"/>
                    <measurement group_id="O2" value="-49.55" lower_limit="-64.80" upper_limit="-26.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Remnant Cholesterol</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Remnant Cholesterol</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="269"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-58.39" lower_limit="-72.45" upper_limit="-39.62"/>
                    <measurement group_id="O2" value="-43.31" lower_limit="-60.66" upper_limit="-24.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in HDL-C</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.78" lower_limit="3.03" upper_limit="38.46"/>
                    <measurement group_id="O2" value="15.59" lower_limit="5.26" upper_limit="32.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo A1</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo A1</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" lower_limit="-6.51" upper_limit="12.10"/>
                    <measurement group_id="O2" value="2.56" lower_limit="-6.62" upper_limit="12.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Non-HDL-C</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Non-HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.80" lower_limit="-37.89" upper_limit="-6.95"/>
                    <measurement group_id="O2" value="-14.22" lower_limit="-31.57" upper_limit="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in TC</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in TC</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.28" lower_limit="-29.10" upper_limit="-4.01"/>
                    <measurement group_id="O2" value="-8.64" lower_limit="-23.55" upper_limit="5.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in LDL-C</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in LDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="269"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.90" lower_limit="0.00" upper_limit="76.62"/>
                    <measurement group_id="O2" value="22.96" lower_limit="1.41" upper_limit="51.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in FFAs</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in FFAs</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="219"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.61" lower_limit="-46.76" upper_limit="8.15"/>
                    <measurement group_id="O2" value="-21.41" lower_limit="-45.70" upper_limit="-1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo A2</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo A2</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.92" lower_limit="3.23" upper_limit="31.25"/>
                    <measurement group_id="O2" value="8.33" lower_limit="0.00" upper_limit="20.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo B</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo B</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" lower_limit="-14.74" upper_limit="15.84"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-14.13" upper_limit="12.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo B48</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo B48</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.43" lower_limit="-58.77" upper_limit="60.61"/>
                    <measurement group_id="O2" value="-15.19" lower_limit="-51.08" upper_limit="112.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo B100</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo B100</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.32" lower_limit="-15.58" upper_limit="17.35"/>
                    <measurement group_id="O2" value="-0.87" lower_limit="-13.44" upper_limit="12.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo C2</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo C2</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="270"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.56" lower_limit="-34.50" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-19.81" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo C3</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo C3</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.80" lower_limit="-57.88" upper_limit="-22.27"/>
                    <measurement group_id="O2" value="-26.25" lower_limit="-44.64" upper_limit="-2.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Apo E</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Apo E</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.82" lower_limit="-49.25" upper_limit="-13.04"/>
                    <measurement group_id="O2" value="-30.00" lower_limit="-42.59" upper_limit="-9.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in FGF21</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in FGF21</title>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371.80" lower_limit="97.30" upper_limit="795.00"/>
                    <measurement group_id="O2" value="194.40" lower_limit="57.00" upper_limit="524.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in hsCRP</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in hsCRP</title>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.100" lower_limit="-1.400" upper_limit="0.900"/>
                    <measurement group_id="O2" value="-0.225" lower_limit="-1.700" upper_limit="0.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.60" lower_limit="-57.18" upper_limit="-9.94"/>
                    <measurement group_id="O2" value="-22.03" lower_limit="-46.31" upper_limit="3.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.03" lower_limit="-45.41" upper_limit="-2.97"/>
                    <measurement group_id="O2" value="-13.31" lower_limit="-32.85" upper_limit="10.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.96" lower_limit="-28.26" upper_limit="8.80"/>
                    <measurement group_id="O2" value="-2.31" lower_limit="-21.61" upper_limit="17.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" lower_limit="-22.32" upper_limit="20.37"/>
                    <measurement group_id="O2" value="3.54" lower_limit="-14.98" upper_limit="19.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.33" lower_limit="-4.92" upper_limit="45.07"/>
                    <measurement group_id="O2" value="15.87" lower_limit="-3.79" upper_limit="33.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.51" lower_limit="11.45" upper_limit="96.51"/>
                    <measurement group_id="O2" value="25.53" lower_limit="7.94" upper_limit="57.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.36" lower_limit="18.02" upper_limit="121.43"/>
                    <measurement group_id="O2" value="33.66" lower_limit="8.36" upper_limit="69.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.61" lower_limit="10.19" upper_limit="110.03"/>
                    <measurement group_id="O2" value="27.29" lower_limit="3.08" upper_limit="75.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.50" lower_limit="-17.32" upper_limit="76.72"/>
                    <measurement group_id="O2" value="19.64" lower_limit="-9.16" upper_limit="55.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.92" lower_limit="-46.06" upper_limit="44.10"/>
                    <measurement group_id="O2" value="1.17" lower_limit="-33.87" upper_limit="37.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.63" lower_limit="-59.65" upper_limit="4.76"/>
                    <measurement group_id="O2" value="-24.80" lower_limit="-48.67" upper_limit="7.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.26" lower_limit="-54.63" upper_limit="-13.67"/>
                    <measurement group_id="O2" value="-24.22" lower_limit="-46.23" upper_limit="-7.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.81" lower_limit="-39.69" upper_limit="-12.43"/>
                    <measurement group_id="O2" value="-17.41" lower_limit="-34.43" upper_limit="-3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.67" lower_limit="-21.85" upper_limit="-0.44"/>
                    <measurement group_id="O2" value="-5.62" lower_limit="-18.23" upper_limit="5.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)</title>
        <description>Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.</description>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)</title>
          <description>Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.</description>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.62" lower_limit="-13.84" upper_limit="5.23"/>
                    <measurement group_id="O2" value="-3.71" lower_limit="-13.22" upper_limit="5.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" lower_limit="1.10" upper_limit="4.84"/>
                    <measurement group_id="O2" value="1.54" lower_limit="0.71" upper_limit="3.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles)</title>
        <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles)</title>
          <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.10" lower_limit="-63.62" upper_limit="-14.91"/>
                    <measurement group_id="O2" value="-28.98" lower_limit="-48.61" upper_limit="-2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles-Large)</title>
        <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Particles-Large)</title>
          <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.00" lower_limit="-32.70" upper_limit="-2.40"/>
                    <measurement group_id="O2" value="-8.60" lower_limit="-28.80" upper_limit="-1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.95" lower_limit="-77.20" upper_limit="-5.10"/>
                    <measurement group_id="O2" value="-26.90" lower_limit="-64.80" upper_limit="4.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" lower_limit="-18.10" upper_limit="19.60"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-16.60" upper_limit="24.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.43" lower_limit="-10.07" upper_limit="62.78"/>
                    <measurement group_id="O2" value="12.79" lower_limit="-11.69" upper_limit="43.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.00" lower_limit="-151.00" upper_limit="53.00"/>
                    <measurement group_id="O2" value="-6.00" lower_limit="-127.00" upper_limit="57.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.00" lower_limit="0.00" upper_limit="273.00"/>
                    <measurement group_id="O2" value="8.00" lower_limit="0.00" upper_limit="199.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.00" lower_limit="-198.00" upper_limit="425.00"/>
                    <measurement group_id="O2" value="97.00" lower_limit="-209.00" upper_limit="420.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.96" lower_limit="-9.59" upper_limit="20.58"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-9.74" upper_limit="13.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>umol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" lower_limit="-0.90" upper_limit="1.50"/>
                    <measurement group_id="O2" value="0.30" lower_limit="-1.10" upper_limit="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>umol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" lower_limit="-3.70" upper_limit="2.80"/>
                    <measurement group_id="O2" value="-0.40" lower_limit="-4.20" upper_limit="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>umol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" lower_limit="-2.90" upper_limit="7.30"/>
                    <measurement group_id="O2" value="1.40" lower_limit="-2.70" upper_limit="5.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.15" lower_limit="-17.67" upper_limit="3.71"/>
                    <measurement group_id="O2" value="-5.46" lower_limit="-15.32" upper_limit="3.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" lower_limit="0.00" upper_limit="3.57"/>
                    <measurement group_id="O2" value="0.51" lower_limit="-0.51" upper_limit="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" lower_limit="-4.35" upper_limit="2.27"/>
                    <measurement group_id="O2" value="-1.15" lower_limit="-4.35" upper_limit="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.03" lower_limit="-73.79" upper_limit="-31.24"/>
                    <measurement group_id="O2" value="-42.76" lower_limit="-58.82" upper_limit="-13.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Triglyceride)</title>
        <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL &amp; Chylomicron Triglyceride)</title>
          <description>Two types of lipoprotein particles were analyzed together as one measurement without distinction.</description>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.30" lower_limit="-73.74" upper_limit="-30.73"/>
                    <measurement group_id="O2" value="-41.55" lower_limit="-58.97" upper_limit="-17.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" lower_limit="-15.75" upper_limit="24.94"/>
                    <measurement group_id="O2" value="-1.19" lower_limit="-15.14" upper_limit="25.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-66.38" lower_limit="-81.70" upper_limit="-45.55"/>
                    <measurement group_id="O2" value="-56.61" lower_limit="-71.34" upper_limit="-32.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.53" lower_limit="-47.32" upper_limit="-13.74"/>
                    <measurement group_id="O2" value="-23.70" lower_limit="-41.03" upper_limit="-5.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.49" lower_limit="-53.81" upper_limit="-16.78"/>
                    <measurement group_id="O2" value="-27.67" lower_limit="-47.17" upper_limit="-7.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B</title>
        <time_frame>52 Weeks</time_frame>
        <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B</title>
          <population>Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.</population>
          <units>Ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="267"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.210" lower_limit="0.050" upper_limit="0.420"/>
                    <measurement group_id="O2" value="0.150" lower_limit="0.030" upper_limit="0.310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.56" lower_limit="-20.00" upper_limit="14.91"/>
                    <measurement group_id="O2" value="-2.94" lower_limit="-19.27" upper_limit="10.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>K-877</title>
            <description>K-877 0.2 mg Tablets</description>
          </group>
          <group group_id="O2">
            <title>Placebo/Fenofibrate</title>
            <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2</title>
          <units>Percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="270"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.81" lower_limit="-43.96" upper_limit="-4.95"/>
                    <measurement group_id="O2" value="-13.17" lower_limit="-32.52" upper_limit="4.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>52 Weeks</time_frame>
      <desc>Treatment-emergent adverse event (TEAE) was defined as any adverse event that occurred for the first time after the first dose of double-blind study drug or existed prior to the first dose and worsened during the post-dosing period.</desc>
      <group_list>
        <group group_id="E1">
          <title>K-877: 12-Week Efficacy</title>
          <description>K-877 0.2 mg Tablets BID&#xD;
Only AEs with onset in the 12-week efficacy period are included.</description>
        </group>
        <group group_id="E2">
          <title>Placebo:12-Week Efficacy</title>
          <description>Placebo matching K-877 0.2 mg BID&#xD;
Only AEs with onset in the 12-week efficacy period are included.</description>
        </group>
        <group group_id="E3">
          <title>K-877: 40-Week Extension</title>
          <description>Participants randomized to receive K-877 0.2 mg tablets twice daily in the 12-week Efficacy Period continued to receive K-877 0.2 mg tablets BID in the 40-week Extension Period&#xD;
Only AEs with onset in the 40-week extension period are included.</description>
        </group>
        <group group_id="E4">
          <title>Fenofibrate 40-Week Extension</title>
          <description>Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care.&#xD;
Only AEs with onset in the 40-week extension period are included.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Normochromic normocytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic adhesions</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="292"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="154"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical Operations</name_or_title>
      <organization>Kowa Research Institute, Inc.</organization>
      <phone>919-433-1600</phone>
      <email>CTGResults@KowaUS.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03011450
org study id: K-877-303
nct id: NCT03011450
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients
      With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal
      Impairment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percent Change in Fasting TG From Baseline to Week 12
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Remnant Cholesterol
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in HDL-C
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo A1
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Non-HDL-C
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Total Cholesterol
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in LDL-C
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in FFAs
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo A2
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo B
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo B48
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo B100
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo C2
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo C3
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Apo E
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in FGF21
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in hsCRP
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)
time frame: 12 Weeks
description: Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
measure: Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)
time frame: 12 Weeks
description: Two types of lipoprotein particles were analyzed together as one measurement without distinction.
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)
time frame: 12 Weeks
description: Two types of lipoprotein particles were analyzed together as one measurement without distinction.
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)
time frame: 12 Weeks
description: Two types of lipoprotein particles were analyzed together as one measurement without distinction.
measure: Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
time frame: 12 Weeks
measure: Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
time frame: 12 Weeks
measure: Percent Change From Baseline to Week 52 in Fasting TG
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Remnant Cholesterol
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in HDL-C
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo A1
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Non-HDL-C
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in TC
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in LDL-C
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in FFAs
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo A2
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo B
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo B48
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo B100
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo C2
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo C3
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Apo E
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in FGF21
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in hsCRP
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)
time frame: 52 Weeks
description: Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
measure: Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)
time frame: 52 Weeks
description: Two types of lipoprotein particles were analyzed together as one measurement without distinction.
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)
time frame: 52 Weeks
description: Two types of lipoprotein particles were analyzed together as one measurement without distinction.
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)
time frame: 52 Weeks
description: Two types of lipoprotein particles were analyzed together as one measurement without distinction.
measure: Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
time frame: 52 Weeks
measure: Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
time frame: 52 Weeks
measure: Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
time frame: 52 Weeks
arm group label: 12 Week Efficacy
arm group type: Placebo Comparator
description: K-877 or placebo comparator for 12 weeks
arm group label: 40 week extension
arm group type: Active Comparator
description: K-877 or fenofibrate comparator for 40 weeks
intervention type: Drug
intervention name: K-877
arm group label: 12 Week Efficacy
arm group label: 40 week extension
intervention type: Drug
intervention name: Fenofibrate
arm group label: 40 week extension
intervention type: Drug
intervention name: Placebo (for K-877)
arm group label: 12 Week Efficacy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Belarus
country: Bulgaria
country: Czechia
country: Georgia
country: Hungary
country: Poland
country: Russian Federation
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Hypertriglyceridemia
mesh term: Fenofibrate
provided document: 
provided document: 
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 