<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/NCT04447820</url>
  </required_header>
  <id_info>
    <org_study_id>K-877-ER-201</org_study_id>
    <nct_id>NCT04447820</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR</brief_title>
  <official_title>A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels</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>
      A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to&#xD;
      K-877 immediate release (IR) twice daily (BID).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">December 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in fasting triglycerides (TG) from baseline to Day 28</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change in total cholesterol (TC)</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in low-density lipoprotein cholesterol (LDL-C)</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in HDL-C</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in remnant cholesterol</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in non-HDL-C</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in free fatty acids.</measure>
    <time_frame>Baseline to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K-877 plasma concentrations</measure>
    <time_frame>Days 1 and 28</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>K-877-ER Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>K-877-ER dose A administered once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>K-877-ER Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>K-877-ER dose B administered once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>K-877-IR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>K-877-IR administered twice daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>K-877-ER (Dose A)</intervention_name>
    <description>Dose A Oral Administration</description>
    <arm_group_label>K-877-ER Dose A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>K-877-ER (Dose B)</intervention_name>
    <description>Dose B Oral Administration</description>
    <arm_group_label>K-877-ER Dose B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>K-877-IR</intervention_name>
    <description>K-877-IR Oral Administration</description>
    <arm_group_label>K-877-IR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide written informed consent before any study-specific evaluation is&#xD;
             performed&#xD;
&#xD;
          -  At screening, have a mean fasting TG level of ≥180 mg/dL and &lt;550 mg/dL; at subsequent&#xD;
             Qualification Period visits confirm fasting TG level of ≥200 mg/dL and &lt;500 mg/dL&#xD;
&#xD;
          -  Able to meet all inclusion criteria outlined in clinical study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9&#xD;
             inhibitors during the study&#xD;
&#xD;
          -  Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated&#xD;
             receptor alpha agonists&#xD;
&#xD;
          -  Meet any other exclusion criteria outlined in clinical study protocol&#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>Pinnacle Research Group</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</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>Columbus Regional Health</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prism Research</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</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>Medpace Clinical Pharmacology, LLC</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</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>Summit Research Group, LLC</name>
      <address>
        <city>Munroe Falls</city>
        <state>Ohio</state>
        <zip>44262</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>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <disposition_first_submitted>December 1, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>December 1, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 7, 2021</disposition_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</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>Dyslipidemias</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04447820
org study id: K-877-ER-201
nct id: NCT04447820
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to
      K-877 immediate release (IR) twice daily (BID).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent change in fasting triglycerides (TG) from baseline to Day 28
time frame: Baseline to Day 28
measure: Percent change in total cholesterol (TC)
time frame: Baseline to Day 28
measure: Percent change in low-density lipoprotein cholesterol (LDL-C)
time frame: Baseline to Day 28
measure: Percent change in HDL-C
time frame: Baseline to Day 28
measure: Percent change in remnant cholesterol
time frame: Baseline to Day 28
measure: Percent change in non-HDL-C
time frame: Baseline to Day 28
measure: Percent change in free fatty acids.
time frame: Baseline to Day 28
measure: K-877 plasma concentrations
time frame: Days 1 and 28
arm group label: K-877-ER Dose A
arm group type: Experimental
description: K-877-ER dose A administered once daily
arm group label: K-877-ER Dose B
arm group type: Experimental
description: K-877-ER dose B administered once daily
arm group label: K-877-IR
arm group type: Experimental
description: K-877-IR administered twice daily.
intervention type: Drug
intervention name: K-877-ER (Dose A)
description: Dose A Oral Administration
arm group label: K-877-ER Dose A
intervention type: Drug
intervention name: K-877-ER (Dose B)
description: Dose B Oral Administration
arm group label: K-877-ER Dose B
intervention type: Drug
intervention name: K-877-IR
description: K-877-IR Oral Administration
arm group label: K-877-IR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Dyslipidemias