<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/NCT02260648</url>
  </required_header>
  <id_info>
    <org_study_id>14501</org_study_id>
    <secondary_id>I1V-JE-EIBG</secondary_id>
    <nct_id>NCT02260648</nct_id>
  </id_info>
  <brief_title>A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia</brief_title>
  <official_title>A Double-Blind Efficacy and Safety Study of Evacetrapib in Combination With Atorvastatin in Japanese Patients With Primary Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the efficacy and safety of the study drug known&#xD;
      as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese&#xD;
      participants with primary hypercholesterolemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study termination due to insufficient efficacy.&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in LDL-C (Direct)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Non HDL-C</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Lipoprotein-a</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apolipoprotein A-I</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to Week 12 in Apolipoprotein B</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Evacetrapib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ezetimibe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evacetrapib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Evacetrapib</arm_group_label>
    <other_name>LY2484595</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Ezetimibe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Evacetrapib</arm_group_label>
    <arm_group_label>Ezetimibe</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be treated with atorvastatin 10 mg/day for at least 30 days prior to study&#xD;
             initiation.&#xD;
&#xD;
          -  Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C&#xD;
             levels (measured by a direct method) that meet the following criteria. (Participant&#xD;
             categories are based on the definition in Japan Atherosclerosis Society 2012&#xD;
             guidelines.)&#xD;
&#xD;
               -  Category I: 160 mg/deciliter (dL)≤LDL-C&#xD;
&#xD;
               -  Category II: 140 mg/dL≤LDL-C&#xD;
&#xD;
               -  Category III: 120 mg/dL≤LDL-C&#xD;
&#xD;
               -  Secondary prevention: 100 mg/dL≤LDL-C&#xD;
&#xD;
          -  Have triglycerides (TG) ≤400 mg/dL.&#xD;
&#xD;
          -  Have HDL-C &lt;100 mg/dL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants on LDL apheresis or plasma apheresis.&#xD;
&#xD;
          -  Participants with secondary hypercholesterolemia or homozygous familial&#xD;
             hypercholesterolemia.&#xD;
&#xD;
          -  Any planned angiography. If angiography is planned, participants may be screened and&#xD;
             enrolled after all such planned procedures are completed.&#xD;
&#xD;
          -  History of any of the following conditions &lt; 90 days prior to study initiation&#xD;
&#xD;
               -  acute coronary syndrome (unstable angina, acute myocardial infarction)&#xD;
&#xD;
               -  symptomatic peripheral arterial disease&#xD;
&#xD;
               -  invasive treatment of carotid artery disease&#xD;
&#xD;
               -  ischemic stroke or transient ischemic attack (TIA)&#xD;
&#xD;
               -  intracranial hemorrhage&#xD;
&#xD;
          -  History of abdominal aortic aneurysm.&#xD;
&#xD;
          -  Participants with a history of intolerance/hypersensitivity to ezetimibe or statins.&#xD;
&#xD;
          -  Have systolic blood pressure (SBP) &gt; 160 millimeters of mercury (mm Hg) or diastolic&#xD;
             blood pressure (DBP) &gt; 100 mm Hg.&#xD;
&#xD;
          -  Have a hemoglobin A1c ≥8.4% (National Glycohemoglobin Standardization Program).&#xD;
&#xD;
          -  During the study period, participants who plan to use, are likely to require, or&#xD;
             unwilling or unable to stop with adequate washout any prescription, over the counter&#xD;
             (OTC) medication, supplements or health foods with the intent to treat serum lipids&#xD;
             (LDL-C, HDL-C, TG) including but not limited to these classes of drugs: statin (except&#xD;
             for atorvastatin 10 mg), ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA)&#xD;
             and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic&#xD;
             agents within 8 weeks before study initiation are excluded from the study.&#xD;
&#xD;
          -  Have been exposed to cholesteryl ester transfer protein (CETP) inhibitors (for&#xD;
             example, anacetrapib or dalcetrapib).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hyogo</city>
        <zip>650-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ibaragi</city>
        <zip>311-3516</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-4153</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kyoto</city>
        <zip>6150035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Osaka</city>
        <zip>530-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saitama</city>
        <zip>350-1305</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Shizuoka</city>
        <zip>424-0855</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>February 18, 2018</results_first_submitted>
  <results_first_submitted_qc>February 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2018</results_first_posted>
  <disposition_first_submitted>August 13, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>August 13, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 16, 2016</disposition_first_posted>
  <last_update_submitted>February 18, 2018</last_update_submitted>
  <last_update_submitted_qc>February 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</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>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Ezetimibe</mesh_term>
    <mesh_term>Evacetrapib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Evacetrapib</title>
          <description>130 milligram (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo and 10 mg atorvastatin administered orally (PO) once a day for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Ezetimibe</title>
          <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinue Due to Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Evacetrapib</title>
          <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Ezetimibe</title>
          <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
        </group>
        <group group_id="B4">
          <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="53"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="50"/>
            <count group_id="B4" value="149"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.5" spread="11.53"/>
                    <measurement group_id="B2" value="57.9" spread="10.81"/>
                    <measurement group_id="B3" value="58.0" spread="10.40"/>
                    <measurement group_id="B4" value="58.2" spread="10.87"/>
                  </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="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification</title>
        <description>The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification</title>
          <description>The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in LDL-C</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.37" spread="3.108"/>
                    <measurement group_id="O2" value="-3.75" spread="3.264"/>
                    <measurement group_id="O3" value="-27.31" spread="3.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)</title>
        <description>The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)</title>
          <description>The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in HDL-C</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.96" spread="5.150"/>
                    <measurement group_id="O2" value="-0.90" spread="5.363"/>
                    <measurement group_id="O3" value="-3.12" spread="5.166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in LDL-C (Direct)</title>
        <description>The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in LDL-C (Direct)</title>
          <description>The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in LDL-C (Direct)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.17" spread="2.708"/>
                    <measurement group_id="O2" value="-3.40" spread="2.845"/>
                    <measurement group_id="O3" value="-28.96" spread="2.726"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Non HDL-C</title>
        <description>The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Non HDL-C</title>
          <description>The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in non HDL-C</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.01" spread="2.455"/>
                    <measurement group_id="O2" value="-6.42" spread="2.577"/>
                    <measurement group_id="O3" value="-27.35" spread="2.468"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Lipoprotein-a</title>
        <description>The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Lipoprotein-a</title>
          <description>The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in Lipoprotein-a</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.17" spread="4.024"/>
                    <measurement group_id="O2" value="7.78" spread="3.895"/>
                    <measurement group_id="O3" value="0.68" spread="3.704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apolipoprotein A-I</title>
        <description>The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apolipoprotein A-I</title>
          <description>The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in Apolipoprotein A-I</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.8" spread="2.27"/>
                    <measurement group_id="O2" value="0.6" spread="2.44"/>
                    <measurement group_id="O3" value="-0.6" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to Week 12 in Apolipoprotein B</title>
        <description>The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Ezetimibe</title>
            <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 12 in Apolipoprotein B</title>
          <description>The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.</description>
          <population>All participants who received at least one dose of study drug.</population>
          <units>percent change in Apolipoprotien B</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.4" spread="2.42"/>
                    <measurement group_id="O2" value="-3.0" spread="2.60"/>
                    <measurement group_id="O3" value="-20.4" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Evacetrapib</title>
          <description>130 mg evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Ezetimibe</title>
          <description>10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="18" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="46"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Presbyacusis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Electrocardiogram qt prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Temporomandibular joint syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mental fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Erythema ab igne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated prematurely due to insufficient efficacy of the I1V-MC-EIAN (NCT01687998) study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT02260648
org study id: 14501
secondary id: I1V-JE-EIBG
nct id: NCT02260648
lead sponsor: 
has dmc: No
The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese
      participants with primary hypercholesterolemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
time frame: Baseline, Week 12
description: The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.
measure: Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)
time frame: Baseline, Week 12
description: The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.
measure: Percent Change From Baseline to Week 12 in LDL-C (Direct)
time frame: Baseline, Week 12
description: The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.
measure: Percent Change From Baseline to Week 12 in Non HDL-C
time frame: Baseline, Week 12
description: The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.
measure: Percent Change From Baseline to Week 12 in Lipoprotein-a
time frame: Baseline, Week 12
description: The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.
measure: Percent Change From Baseline to Week 12 in Apolipoprotein A-I
time frame: Baseline, Week 12
description: The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B
time frame: Baseline, Week 12
description: The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.
arm group label: Evacetrapib
arm group type: Experimental
description: 130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
arm group label: Ezetimibe
arm group type: Active Comparator
description: 10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
intervention type: Drug
intervention name: Evacetrapib
description: Administered orally
arm group label: Evacetrapib
other name: LY2484595
intervention type: Drug
intervention name: Ezetimibe
description: Administered orally
arm group label: Ezetimibe
intervention type: Drug
intervention name: Atorvastatin
description: Administered orally
arm group label: Evacetrapib
arm group label: Ezetimibe
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Atorvastatin
mesh term: Ezetimibe
mesh term: Evacetrapib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated prematurely due to insufficient efficacy of the I1V-MC-EIAN (NCT01687998) study.
point of contact: 