<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/NCT02260635</url>
  </required_header>
  <id_info>
    <org_study_id>14503</org_study_id>
    <secondary_id>I1V-JE-EIBI</secondary_id>
    <nct_id>NCT02260635</nct_id>
  </id_info>
  <brief_title>A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia</brief_title>
  <official_title>A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension 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 in Japanese participants with primary hypercholesterolemia. The double blind&#xD;
      treatment period will last for 12 weeks and the open-label extension period will last for an&#xD;
      additional 40 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study termination due to insufficient efficacy.&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">July 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>Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in LDL-C (Direct)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non HDL-C</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lipoprotein-a</measure>
    <time_frame>Baseline, Week 12, Week 52</time_frame>
    <description>LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apolipoprotein A-I</measure>
    <time_frame>Baseline, Week 12, Week 52</time_frame>
    <description>LS Mean from ANCOVA model adjusted for baseline and treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apolipoprotein B</measure>
    <time_frame>Baseline, Week 12, Week 52</time_frame>
    <description>LS Mean from ANCOVA model adjusted for baseline and treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</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 given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</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>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>LY2484595</other_name>
  </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;
          -  Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C&#xD;
             levels (measured by a direct method at baseline) that meet the following criteria.&#xD;
             (Participant categories are based on the definition in Japan Atherosclerosis Society&#xD;
             2012 guidelines.)&#xD;
&#xD;
               -  Category I: 160 mg/deciliter (dL)≤LDL-C&lt;200 mg/dL&#xD;
&#xD;
               -  Category II: 140 mg/dL≤LDL-C&lt;175 mg/dL&#xD;
&#xD;
               -  Category III: 120 mg/dL≤LDL-C&lt;150 mg/dL&#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 familial 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 any conditions:&#xD;
&#xD;
               -  Stable angina or acute coronary syndrome (unstable angina, myocardial&#xD;
                  infarction), old myocardial infarction or a coronary revascularization procedure&#xD;
                  including stent placement, or symptomatic carotid artery disease&#xD;
&#xD;
               -  peripheral arterial disease&#xD;
&#xD;
               -  ischemic stroke or transient ischemic attack (TIA)&#xD;
&#xD;
               -  intracranial hemorrhage&#xD;
&#xD;
               -  abdominal aortic aneurysm&#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;
             medication, supplements or health foods with the intent to treat serum lipids (LDL-C,&#xD;
             HDL-C, TG) including but not limited to these classes of drugs: statin, ezetimibe,&#xD;
             bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).&#xD;
             Participants taking probucol, fibrate or nicotinic agents within 8 weeks before&#xD;
             screening are excluded from the study.&#xD;
&#xD;
          -  Have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib&#xD;
             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>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>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>September 3, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 3, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 18, 2015</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>Evacetrapib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Evacetrapib</title>
          <description>130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blind Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Failure to Meet Randomization Criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Extension</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </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="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Evacetrapib</title>
          <description>130 milligrams (mg) evacetrapib given orally once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo given orally once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.</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="27"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="54"/>
          </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="52.2" spread="10.19"/>
                    <measurement group_id="B2" value="53.3" spread="10.13"/>
                    <measurement group_id="B3" value="52.8" spread="10.08"/>
                  </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="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </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_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_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_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_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_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="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </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>Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values measured by beta quantification at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</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>Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values measured by beta quantification at baseline, and at least 1 post-baseline measurement.</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="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.27" spread="3.908"/>
                    <measurement group_id="O2" value="0.00" spread="3.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)</title>
        <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)</title>
          <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.</population>
          <units>percent change of 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="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.57" spread="6.697"/>
                    <measurement group_id="O2" value="-0.45" spread="6.805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in LDL-C (Direct)</title>
        <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C direct values at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in LDL-C (Direct)</title>
          <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C direct values at baseline, and at least 1 post-baseline measurement.</population>
          <units>percent change of 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="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.86" spread="3.163"/>
                    <measurement group_id="O2" value="0.22" spread="3.226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non HDL-C</title>
        <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable Non HDL-C values at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non HDL-C</title>
          <description>LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable Non HDL-C values at baseline, and at least 1 post-baseline measurement.</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="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.48" spread="3.171"/>
                    <measurement group_id="O2" value="-0.03" spread="3.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lipoprotein-a</title>
        <description>LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.</description>
        <time_frame>Baseline, Week 12, Week 52</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable Lipoprotein-a values at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lipoprotein-a</title>
          <description>LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable Lipoprotein-a values at baseline, and at least 1 post-baseline measurement.</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="17"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.71" spread="6.574"/>
                    <measurement group_id="O2" value="3.54" spread="5.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Week 52 data not available due to early termination of this study.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Week 52 data not available due to early termination of this study.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apolipoprotein A-I</title>
        <description>LS Mean from ANCOVA model adjusted for baseline and treatment.</description>
        <time_frame>Baseline, Week 12, Week 52</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein A-I values at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apolipoprotein A-I</title>
          <description>LS Mean from ANCOVA model adjusted for baseline and treatment.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein A-I values at baseline, and at least 1 post-baseline measurement.</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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1" spread="3.44"/>
                    <measurement group_id="O2" value="-2.5" spread="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Week 52 data not available due to early termination of this study.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Week 52 data not available due to early termination of this study.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apolipoprotein B</title>
        <description>LS Mean from ANCOVA model adjusted for baseline and treatment.</description>
        <time_frame>Baseline, Week 12, Week 52</time_frame>
        <population>All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein B values at baseline, and at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Evacetrapib</title>
            <description>130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apolipoprotein B</title>
          <description>LS Mean from ANCOVA model adjusted for baseline and treatment.</description>
          <population>All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein B values at baseline, and at least 1 post-baseline measurement.</population>
          <units>percent change in Apolipoprotein 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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.0" spread="2.65"/>
                    <measurement group_id="O2" value="-1.3" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Week 52 data not available due to early termination of this study.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Week 52 data not available due to early termination of this study.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Evacetrapib Double Blind Treatment Period</title>
          <description>130mg evacetrapib given PO once a day for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Double Blind Treatment Period</title>
          <description>Placebo given PO once a day for 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>Evacetrapib Open Label Extension</title>
          <description>Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</description>
        </group>
        <group group_id="E4">
          <title>Placebo/Evacetrapib Open Label Extension</title>
          <description>Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </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="5" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Influenza b virus test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </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="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Occipital neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wisdom teeth removal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </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 anticipated Inefficient efficacy of the I1V-MC-EIAN (NCT01687998) study, therefore Week 52 data is not available.</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/NCT02260635
org study id: 14503
secondary id: I1V-JE-EIBI
nct id: NCT02260635
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 in Japanese participants with primary hypercholesterolemia. The double blind
      treatment period will last for 12 weeks and the open-label extension period will last for an
      additional 40 weeks.
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: Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
measure: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
time frame: Baseline, Week 12
description: LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
measure: Percent Change From Baseline in LDL-C (Direct)
time frame: Baseline, Week 12
description: LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
measure: Percent Change From Baseline in Non HDL-C
time frame: Baseline, Week 12
description: LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
measure: Percent Change From Baseline in Lipoprotein-a
time frame: Baseline, Week 12, Week 52
description: LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.
measure: Percent Change From Baseline in Apolipoprotein A-I
time frame: Baseline, Week 12, Week 52
description: LS Mean from ANCOVA model adjusted for baseline and treatment.
measure: Percent Change From Baseline in Apolipoprotein B
time frame: Baseline, Week 12, Week 52
description: LS Mean from ANCOVA model adjusted for baseline and treatment.
arm group label: Evacetrapib
arm group type: Experimental
description: 130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
intervention type: Drug
intervention name: Evacetrapib
description: Administered orally
arm group label: Evacetrapib
arm group label: Placebo
other name: LY2484595
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: 
country: Japan
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Evacetrapib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated prematurely due to anticipated Inefficient efficacy of the I1V-MC-EIAN (NCT01687998) study, therefore Week 52 data is not available.
point of contact: 