<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/NCT03823703</url>
  </required_header>
  <id_info>
    <org_study_id>CORT118335-860</org_study_id>
    <nct_id>NCT03823703</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)</brief_title>
  <official_title>A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corcept Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corcept Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and&#xD;
      efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis&#xD;
      (NASH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled study that assessed the safety&#xD;
      efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic&#xD;
      Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were&#xD;
      randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12&#xD;
      weeks.&#xD;
&#xD;
      Due to observations related to safety, the study was terminated prior to completion and study&#xD;
      objectives, endpoints, and procedures were modified as specified in the protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH&#xD;
  </why_stopped>
  <start_date type="Actual">November 4, 2020</start_date>
  <completion_date type="Actual">April 5, 2021</completion_date>
  <primary_completion_date type="Actual">April 5, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction</measure>
    <time_frame>Baseline and up to ~Day 95</time_frame>
    <description>The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF</measure>
    <time_frame>Baseline and up to ~Day 95</time_frame>
    <description>The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of &lt;30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Aspartate Aminotransferase</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alanine Aminotransferase</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gamma-glutamyl Transferase</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Propeptide of Type III Collagen</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Enhanced Liver Fibrosis Score</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo</measure>
    <time_frame>Baseline and up to ~Day 95</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo</measure>
    <time_frame>Baseline and up to ~Day 95</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Nonalcoholic Steatohepatitis (NASH)</condition>
  <arm_group>
    <arm_group_label>Miricorilant- 900 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miricorilant- 600 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received 6 placebo tablets orally once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miricorilant</intervention_name>
    <description>Tablets taken orally</description>
    <arm_group_label>Miricorilant- 600 mg</arm_group_label>
    <arm_group_label>Miricorilant- 900 mg</arm_group_label>
    <other_name>CORT118335</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets</description>
    <arm_group_label>Miricorilant- 600 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of NASH based on a biopsy obtained within the last year OR&#xD;
&#xD;
          -  Have a diagnosis of presumed NASH based on blood tests and scans&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated in another clinical trial within the last year and received active&#xD;
             treatment for NASH&#xD;
&#xD;
          -  Have participated in another clinical trial for any other indication within the last 3&#xD;
             months&#xD;
&#xD;
          -  Are pregnant or lactating women&#xD;
&#xD;
          -  Have a BMI &lt;18 kg/m^2&#xD;
&#xD;
          -  Have had liver transplantation or plan to have liver transplantation during the study&#xD;
&#xD;
          -  Have type 1 diabetes or poorly controlled type 2 diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Director</last_name>
    <role>Study Director</role>
    <affiliation>Corcept Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 207</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 208</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 209</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 227</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 214</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 233</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 234</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 210</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 228</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>61434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 232</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 211</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 213</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 215</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 212</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 226</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.corcept.com/wp-content/uploads/sites/3/2021/11/AASLD2021-poster-11102021-updated.pdf</url>
    <description>Poster #:LP34</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>July 6, 2022</results_first_submitted>
  <results_first_submitted_qc>August 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2022</results_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nonalcoholic Steatohepatitis</keyword>
  <keyword>NASH</keyword>
  <keyword>Nonalcoholic Fatty Liver Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03823703/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03823703/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Twelve adult patients with presumed NASH were enrolled in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Miricorilant- 900 mg</title>
          <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
        </group>
        <group group_id="P2">
          <title>Miricorilant- 600 mg</title>
          <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants received 6 placebo tablets orally once daily.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor request</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Miricorilant- 900 mg</title>
          <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
        </group>
        <group group_id="B2">
          <title>Miricorilant- 600 mg</title>
          <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants received 6 placebo tablets orally once daily.</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="3"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="12"/>
          </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="55.7" spread="14.74"/>
                    <measurement group_id="B2" value="54.2" spread="19.87"/>
                    <measurement group_id="B3" value="43.3" spread="15.15"/>
                    <measurement group_id="B4" value="50.9" spread="16.68"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </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>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Fat Content (LFC) Assessed by MRI-PDFF</title>
          <units>Percentage of liver fat content</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.57" spread="6.038"/>
                    <measurement group_id="B2" value="15.70" spread="6.536"/>
                    <measurement group_id="B3" value="19.93" spread="8.750"/>
                    <measurement group_id="B4" value="19.33" spread="7.526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) &amp; Gamma Glutamyl Transferase (GGT)</title>
          <units>Units/Liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>AST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.7" spread="8.14"/>
                    <measurement group_id="B2" value="25.6" spread="12.76"/>
                    <measurement group_id="B3" value="31" spread="4.08"/>
                    <measurement group_id="B4" value="29.9" spread="9.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.3" spread="15.63"/>
                    <measurement group_id="B2" value="33.2" spread="15.94"/>
                    <measurement group_id="B3" value="54.0" spread="12.11"/>
                    <measurement group_id="B4" value="44.9" spread="16.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.7" spread="19.63"/>
                    <measurement group_id="B2" value="26.2" spread="9.20"/>
                    <measurement group_id="B3" value="59.0" spread="50.29"/>
                    <measurement group_id="B4" value="43.8" spread="32.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Propeptide of Type III Collagen (Pro-C3)</title>
          <units>micrograms/liter (μg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.13" spread="5.350"/>
                    <measurement group_id="B2" value="11.20" spread="2.189"/>
                    <measurement group_id="B3" value="13.73" spread="4.727"/>
                    <measurement group_id="B4" value="13.28" spread="4.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Enhanced Liver Fibrosis Score</title>
          <units>ELF score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.713" spread="1.011"/>
                    <measurement group_id="B2" value="9.358" spread="0.486"/>
                    <measurement group_id="B3" value="9.330" spread="0.805"/>
                    <measurement group_id="B4" value="9.438" spread="0.690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction</title>
        <description>The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and up to ~Day 95</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction</title>
          <description>The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-50.28" spread="13.723"/>
                    <measurement group_id="O2" value="-22.94" spread="71.943"/>
                    <measurement group_id="O3" value="4.63" spread="5.232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF</title>
        <description>The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of &lt;30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and up to ~Day 95</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF</title>
          <description>The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of &lt;30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responders with a reduction in LFC from baseline of ≥30%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-responders with a reduction in LFC from baseline of &lt;30%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Aspartate Aminotransferase</title>
        <description>The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline AST assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Aspartate Aminotransferase</title>
          <description>The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline AST assessment.</population>
          <units>units per liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="346.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O2" value="321.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O3" value="-9.5" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alanine Aminotransferase</title>
        <description>The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline ALT assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alanine Aminotransferase</title>
          <description>The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline ALT assessment.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="810.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O2" value="826.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O3" value="-16" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gamma-glutamyl Transferase</title>
        <description>The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline GGT assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gamma-glutamyl Transferase</title>
          <description>The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline GGT assessment.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O2" value="82.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O3" value="-26.0" spread="31.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Propeptide of Type III Collagen</title>
        <description>The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline pro-C3 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Propeptide of Type III Collagen</title>
          <description>The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline pro-C3 assessment.</population>
          <units>μg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O3" value="-1.65" spread="2.475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Enhanced Liver Fibrosis Score</title>
        <description>The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>The analysis population included all participants who were randomized to the study and had a post-baseline liver fibrosis assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Enhanced Liver Fibrosis Score</title>
          <description>The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.</description>
          <population>The analysis population included all participants who were randomized to the study and had a post-baseline liver fibrosis assessment.</population>
          <units>ELF score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.050" spread="NA">No standard deviation because n=1.</measurement>
                    <measurement group_id="O3" value="0.225" spread="0.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo</title>
        <time_frame>Baseline and up to ~Day 95</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo</title>
        <time_frame>Baseline and up to ~Day 95</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Miricorilant- 900 mg</title>
            <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Miricorilant- 600 mg</title>
            <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received 6 placebo tablets orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.</time_frame>
      <desc>The analysis population included all patients who received at least 1 dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Miricorilant- 900 mg</title>
          <description>Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.</description>
        </group>
        <group group_id="E2">
          <title>Miricorilant- 600 mg</title>
          <description>Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received 6 placebo tablets orally once daily.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Electrocardiogram abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </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>No individual publications will be allowed before publication of the multicenter results, except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to observations related to safety, the study was terminated by the Sponsor prior to completion. The sample size at the time of study termination did not support formal tests to assess statistical differences between treatment groups, and therefore, no efficacy analyses specified in the protocol were performed. Descriptive statistics for efficacy endpoints are provided, but since no patient reached the Week 12 visit, and therefore, descriptive statistics at Week 12 are not presented.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Corcept Therapeutics Incorporated</organization>
      <phone>650-327-3270</phone>
      <email>info@corcept.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03823703
org study id: CORT118335-860
nct id: NCT03823703
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and
      efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis
      (NASH).
This is a randomized, double-blind, placebo-controlled study that assessed the safety
      efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic
      Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were
      randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12
      weeks.

      Due to observations related to safety, the study was terminated prior to completion and study
      objectives, endpoints, and procedures were modified as specified in the protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
time frame: Baseline and up to ~Day 95
description: The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
time frame: Baseline and up to ~Day 95
description: The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of <30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Change From Baseline in Aspartate Aminotransferase
time frame: Baseline and Week 6
description: The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Change From Baseline in Alanine Aminotransferase
time frame: Baseline and Week 6
description: The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Change From Baseline in Gamma-glutamyl Transferase
time frame: Baseline and Week 6
description: The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Change From Baseline in Propeptide of Type III Collagen
time frame: Baseline and Week 6
description: The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Change From Baseline in Enhanced Liver Fibrosis Score
time frame: Baseline and Week 6
description: The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
measure: Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo
time frame: Baseline and up to ~Day 95
measure: Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo
time frame: Baseline and up to ~Day 95
arm group label: Miricorilant- 900 mg
arm group type: Experimental
description: Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
arm group label: Miricorilant- 600 mg
arm group type: Experimental
description: Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received 6 placebo tablets orally once daily.
intervention type: Drug
intervention name: Miricorilant
description: Tablets taken orally
arm group label: Miricorilant- 600 mg
arm group label: Miricorilant- 900 mg
other name: CORT118335
intervention type: Drug
intervention name: Placebo
description: Placebo tablets
arm group label: Miricorilant- 600 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Director
role: Study Director
affiliation: Corcept Therapeutics
facility: 
facility: 
facility: 
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country: United States
url: http://www.corcept.com/wp-content/uploads/sites/3/2021/11/AASLD2021-poster-11102021-updated.pdf
description: Poster #:LP34
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to observations related to safety, the study was terminated by the Sponsor prior to completion. The sample size at the time of study termination did not support formal tests to assess statistical differences between treatment groups, and therefore, no efficacy analyses specified in the protocol were performed. Descriptive statistics for efficacy endpoints are provided, but since no patient reached the Week 12 visit, and therefore, descriptive statistics at Week 12 are not presented.
point of contact: 