<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/NCT03763877</url>
  </required_header>
  <id_info>
    <org_study_id>PXL770-004</org_study_id>
    <nct_id>NCT03763877</nct_id>
  </id_info>
  <brief_title>A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poxel SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poxel SA</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12&#xD;
      weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary&#xD;
      endpoint will be the assessment of the change in the percentage of liver fat mass (assessed&#xD;
      by MRI-PDFF).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 3, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol From Baseline to Week12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides From Baseline to Week12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 &lt; 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 &gt; 3.25: cirrhosis.&#xD;
Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight From Baseline to Week 12/End of Treatment</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Nonalcoholic Fatty Liver</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PXL770 Dose 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PXL770 Dose 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PXL770 Dose 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PXL770</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients have given written informed consent&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²&#xD;
&#xD;
          -  For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or&#xD;
             under stable oral glucose lowering drug&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]&#xD;
&#xD;
          -  Alanine amino transferase (ALT) &gt; 20 IU/L in females and &gt; 30 IU/L in males&#xD;
&#xD;
          -  Hepatic steatosis (MRI-PDFF ≥ 10%)&#xD;
&#xD;
          -  Effective contraception for women of child bearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of another form of liver disease&#xD;
&#xD;
          -  Evidence of liver cirrhosis&#xD;
&#xD;
          -  Evidence of hepatic impairment&#xD;
&#xD;
          -  Positive serologic evidence of current infectious liver disease&#xD;
&#xD;
          -  History of excessive alcohol intake&#xD;
&#xD;
          -  Acute cardiovascular disease with 24 weeks prior to screening&#xD;
&#xD;
          -  Uncontrolled high blood pressure&#xD;
&#xD;
          -  Any disease which in the Investigator's opinion which in the Investigator's opinion&#xD;
             would exclude the patient from the study&#xD;
&#xD;
          -  Use of non-permitted concomitant medication&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study Site 02</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 01</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 11</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 15</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 10</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 03</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 07</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 05</name>
      <address>
        <city>West Monroe</city>
        <state>Louisiana</state>
        <zip>71291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 08</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 09</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 13</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 06</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 04</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 12</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 14</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/34560015/</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>August 11, 2021</results_first_submitted>
  <results_first_submitted_qc>October 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2021</results_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <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>July 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03763877/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>September 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03763877/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were screened for the study at 15 sites in the United States between 29Mar19 and 13Mar20.</recruitment_details>
      <pre_assignment_details>Following a Screening period of maximum 2 weeks, eligible participants entered in a single-blind placebo Run-in period of 4 weeks. This Run-in period was set to reduce any bias regarding placebo effect, to assess patient compliance, and to minimize the possible confounding influence of dietary and activity changes. Only participants who have met all the applicable Inclusion criteria and none of the Exclusion criteria at the end the Run-in period were to be randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo: Oral capsule&#xD;
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>PXL770 250 mg QD</title>
          <description>PXL770 250 mg: Oral capsule Placebo: Oral capsule&#xD;
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:&#xD;
1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning&#xD;
2 capsules of placebo in the evening</description>
        </group>
        <group group_id="P3">
          <title>PXL770 250 mg BID</title>
          <description>PXL770 250 mg: Oral capsule Placebo: Oral capsule&#xD;
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:&#xD;
1 capsule of PXL770 250 mg + 1 capsule of placebo in the morning&#xD;
1 capsule of PXL770 250 mg + 1 capsule of placebo in the evening</description>
        </group>
        <group group_id="P4">
          <title>PXL770 500 mg QD</title>
          <description>PXL770 250 mg: Oral capsule Placebo: Oral capsule&#xD;
Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks:&#xD;
2 capsules of PXL770 250 mg&#xD;
2 capsules of placebo in the evening</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Double-blind Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed the Double-blind Period</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>PXL770 250 mg QD</title>
          <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
        </group>
        <group group_id="B3">
          <title>PXL770 250 mg BID</title>
          <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
        </group>
        <group group_id="B4">
          <title>PXL770 500 mg QD</title>
          <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
        </group>
        <group group_id="B5">
          <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="31"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="29"/>
            <count group_id="B5" value="120"/>
          </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="51.5" spread="12.17"/>
                    <measurement group_id="B2" value="52.5" spread="12.93"/>
                    <measurement group_id="B3" value="50.6" spread="12.26"/>
                    <measurement group_id="B4" value="55.7" spread="12.63"/>
                    <measurement group_id="B5" value="52.5" spread="12.49"/>
                  </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="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="42"/>
                  </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="7"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="78"/>
                  </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 group_id="B5" 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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="103"/>
                  </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 group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>T2DM status (stratification group)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>T2DM</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-T2DM</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)</title>
        <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Intent-to-treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)</title>
          <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
          <population>Intent-to-treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>percentage</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" spread="6.344"/>
                    <measurement group_id="O2" value="-1.03" spread="6.764"/>
                    <measurement group_id="O3" value="-14.28" spread="6.697"/>
                    <measurement group_id="O4" value="-14.68" spread="6.452"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9883</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.926</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.42</ci_lower_limit>
            <ci_upper_limit>15.66</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0842</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.609</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.06</ci_lower_limit>
            <ci_upper_limit>1.78</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0763</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.636</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.51</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)</title>
        <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Per Protocol Set (PPS), defined as all patients in the ITTS who complete the double-blind treatment period and have an overall treatment duration ≥8 weeks (≥56 days) without any CSR reportable protocol deviations (PD) that is deemed to affect the primary efficacy endpoint of MRI-PDFF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)</title>
          <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
          <population>Per Protocol Set (PPS), defined as all patients in the ITTS who complete the double-blind treatment period and have an overall treatment duration ≥8 weeks (≥56 days) without any CSR reportable protocol deviations (PD) that is deemed to affect the primary efficacy endpoint of MRI-PDFF.</population>
          <units>percentage</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 group_id="O3" value="23"/>
                <count group_id="O4" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="5.818"/>
                    <measurement group_id="O2" value="-2.27" spread="6.036"/>
                    <measurement group_id="O3" value="-13.94" spread="6.232"/>
                    <measurement group_id="O4" value="-18.00" spread="6.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8283</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.265</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.01</ci_lower_limit>
            <ci_upper_limit>12.85</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0698</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.221</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.60</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0184</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-17.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.207</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.63</ci_lower_limit>
            <ci_upper_limit>-2.99</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)</title>
        <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)</title>
          <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>percentage</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" lower_limit="-8.68" upper_limit="15.46"/>
                    <measurement group_id="O2" value="1.44" lower_limit="-17.85" upper_limit="9.31"/>
                    <measurement group_id="O3" value="-8.32" lower_limit="-28.91" upper_limit="7.29"/>
                    <measurement group_id="O4" value="-15.29" lower_limit="-35.87" upper_limit="7.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5537</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Location Shift</param_type>
            <param_value>-4.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.64</ci_lower_limit>
            <ci_upper_limit>8.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1005</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Location Shift</param_type>
            <param_value>-13.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.19</ci_lower_limit>
            <ci_upper_limit>1.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0387</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Location Shift</param_type>
            <param_value>-18.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.95</ci_lower_limit>
            <ci_upper_limit>-1.58</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])</title>
        <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])</title>
          <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
          <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
          <units>percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.11" spread="9.745"/>
                    <measurement group_id="O2" value="1.15" spread="9.266"/>
                    <measurement group_id="O3" value="-16.71" spread="8.997"/>
                    <measurement group_id="O4" value="-27.24" spread="9.572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5733</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5733</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.00</ci_lower_limit>
            <ci_upper_limit>32.51</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3861</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.61</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.236</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.60</ci_lower_limit>
            <ci_upper_limit>13.38</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1019</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-21.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.916</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.46</ci_lower_limit>
            <ci_upper_limit>4.19</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment</title>
        <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment</title>
          <description>MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>percentage</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.023" spread="1.1117"/>
                    <measurement group_id="O2" value="-0.218" spread="1.1801"/>
                    <measurement group_id="O3" value="-2.548" spread="1.1988"/>
                    <measurement group_id="O4" value="-2.391" spread="1.1399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8617</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.242</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.3873</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.961</ci_lower_limit>
            <ci_upper_limit>2.478</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0609</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model using a multiple imputation procedure based on the fully conditional specification method</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.571</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.3712</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.260</ci_lower_limit>
            <ci_upper_limit>0.117</ci_upper_limit>
            <other_analysis_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0766</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA using a multiple imputation procedure based on the fully conditional specification method</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.414</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.3633</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.087</ci_lower_limit>
            <ci_upper_limit>0.258</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment</title>
        <description>Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.&#xD;
For patients with missing Week 12/End of Treatment, multiple imputation by fully conditional specification methods was used for analysis, although the n counts and percentages reflect only the observed data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment</title>
          <description>Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.&#xD;
For patients with missing Week 12/End of Treatment, multiple imputation by fully conditional specification methods was used for analysis, although the n counts and percentages reflect only the observed data.</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="27"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Relative reduction ≥30%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Relative reduction &lt;30%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5592</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression with multiple imputation</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.744</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.270</ci_lower_limit>
            <ci_upper_limit>11.267</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3747</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression with multiple imputation</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.287</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.368</ci_lower_limit>
            <ci_upper_limit>14.208</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0501</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression with multiple imputation</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.669</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.000</ci_lower_limit>
            <ci_upper_limit>32.149</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>U/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="2.88"/>
                    <measurement group_id="O2" value="0.0" spread="2.95"/>
                    <measurement group_id="O3" value="0.3" spread="3.10"/>
                    <measurement group_id="O4" value="-6.3" spread="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8013</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.3</ci_lower_limit>
            <ci_upper_limit>6.4</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8694</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.2</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
            <other_analysis_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0581</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.9</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <other_analysis_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>U/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="1.95"/>
                    <measurement group_id="O2" value="-1.7" spread="1.99"/>
                    <measurement group_id="O3" value="-2.2" spread="2.08"/>
                    <measurement group_id="O4" value="-7.0" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6681</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8224</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>5.5</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0924</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.2</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>mmol/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.199"/>
                    <measurement group_id="O2" value="0.19" spread="0.205"/>
                    <measurement group_id="O3" value="-0.17" spread="0.211"/>
                    <measurement group_id="O4" value="-0.16" spread="0.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5148</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.256</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0434</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.261</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0494</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.261</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.04</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>percent</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.092"/>
                    <measurement group_id="O2" value="-0.08" spread="0.095"/>
                    <measurement group_id="O3" value="-0.18" spread="0.101"/>
                    <measurement group_id="O4" value="-0.24" spread="0.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2449</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.111</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0502</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.115</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.46</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0123</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.113</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>-0.06</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Cholesterol From Baseline to Week12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Cholesterol From Baseline to Week12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>mmol/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.107" spread="0.1650"/>
                    <measurement group_id="O2" value="-0.144" spread="0.1714"/>
                    <measurement group_id="O3" value="0.058" spread="0.1761"/>
                    <measurement group_id="O4" value="0.081" spread="0.1764"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2510</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.251</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2172</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.682</ci_lower_limit>
            <ci_upper_limit>0.180</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8246</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.049</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2202</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.486</ci_lower_limit>
            <ci_upper_limit>0.388</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9067</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.026</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2216</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.466</ci_lower_limit>
            <ci_upper_limit>0.414</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>mmol/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007" spread="0.0357"/>
                    <measurement group_id="O2" value="-0.025" spread="0.0371"/>
                    <measurement group_id="O3" value="-0.085" spread="0.0381"/>
                    <measurement group_id="O4" value="0.002" spread="0.0375"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6951</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.018</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0468</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.111</ci_lower_limit>
            <ci_upper_limit>0.075</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1030</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.078</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0472</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.171</ci_lower_limit>
            <ci_upper_limit>0.016</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8583</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.008</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0471</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.085</ci_lower_limit>
            <ci_upper_limit>0.102</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>mmol/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.011" spread="0.1401"/>
                    <measurement group_id="O2" value="-0.094" spread="0.1391"/>
                    <measurement group_id="O3" value="0.155" spread="0.1427"/>
                    <measurement group_id="O4" value="0.092" spread="0.1456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5576</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.105</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1777</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.457</ci_lower_limit>
            <ci_upper_limit>0.248</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4261</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.144</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1799</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.213</ci_lower_limit>
            <ci_upper_limit>0.501</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6571</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.081</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1822</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.281</ci_lower_limit>
            <ci_upper_limit>0.443</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Triglycerides From Baseline to Week12/End of Treatment</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Triglycerides From Baseline to Week12/End of Treatment</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>mmol/L</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.156" spread="0.2177"/>
                    <measurement group_id="O2" value="-0.006" spread="0.2278"/>
                    <measurement group_id="O3" value="0.017" spread="0.2330"/>
                    <measurement group_id="O4" value="-0.045" spread="0.2291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5732</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.161</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2851</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.727</ci_lower_limit>
            <ci_upper_limit>0.405</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6312</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.139</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2884</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.712</ci_lower_limit>
            <ci_upper_limit>0.434</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4857</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.201</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2865</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.769</ci_lower_limit>
            <ci_upper_limit>0.368</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment</title>
        <description>Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 &lt; 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 &gt; 3.25: cirrhosis.&#xD;
Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment</title>
          <description>Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 &lt; 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 &gt; 3.25: cirrhosis.&#xD;
Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>Fib-4 score</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.060"/>
                    <measurement group_id="O2" value="-0.07" spread="0.062"/>
                    <measurement group_id="O3" value="-0.09" spread="0.064"/>
                    <measurement group_id="O4" value="-0.15" spread="0.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5737</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.074</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.19</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7563</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.074</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5695</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.075</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight From Baseline to Week 12/End of Treatment</title>
        <description>Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID at least 15 minutes before a meal for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight From Baseline to Week 12/End of Treatment</title>
          <description>Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.</description>
          <population>ITTS, defined as all as-randomized patients who received at least one dose of study treatment.</population>
          <units>kg</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="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="0.476"/>
                    <measurement group_id="O2" value="0.92" spread="0.486"/>
                    <measurement group_id="O3" value="0.20" spread="0.508"/>
                    <measurement group_id="O4" value="0.08" spread="0.505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9552</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.659</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.34</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2633</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.674</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.10</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1962</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed Model Repeated Measures</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.88</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.673</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.21</ci_lower_limit>
            <ci_upper_limit>0.46</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment (T2DM Subgroup)</title>
        <description>Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.&#xD;
For patients with missing Week 12/End of Treatment, multiple imputation by fully conditional specification methods was used for analysis, although the n counts and percentages reflect only the observed data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment (T2DM Subgroup)</title>
          <description>Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF</description>
          <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.&#xD;
For patients with missing Week 12/End of Treatment, multiple imputation by fully conditional specification methods was used for analysis, although the n counts and percentages reflect only the observed data.</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="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Relative reduction ≥30%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Relative reduction &lt;30%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8245</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.353</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.094</ci_lower_limit>
            <ci_upper_limit>19.554</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4140</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.791</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.238</ci_lower_limit>
            <ci_upper_limit>32.752</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0341</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>14.872</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.226</ci_lower_limit>
            <ci_upper_limit>180.452</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Change in ALT From Baseline to Week 12/End of Treatment (T2DM Subgroup)</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ALT From Baseline to Week 12/End of Treatment (T2DM Subgroup)</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
          <units>U/L</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="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="4.36"/>
                    <measurement group_id="O2" value="-2.2" spread="4.20"/>
                    <measurement group_id="O3" value="-3.8" spread="4.19"/>
                    <measurement group_id="O4" value="-12.8" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4626</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.1</ci_lower_limit>
            <ci_upper_limit>7.5</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3160</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.9</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0204</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-14.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.4</ci_lower_limit>
            <ci_upper_limit>-2.4</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Change in AST From Baseline to Week 12/End of Treatment (T2DM Subgroup)</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in AST From Baseline to Week 12/End of Treatment (T2DM Subgroup)</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
          <units>U/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="2.92"/>
                    <measurement group_id="O2" value="-3.7" spread="2.87"/>
                    <measurement group_id="O3" value="-0.9" spread="2.82"/>
                    <measurement group_id="O4" value="-10.7" spread="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4601</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.8</ci_lower_limit>
            <ci_upper_limit>5.0</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9782</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.95</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.1</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0205</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.3</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Change in FPG From Baseline to Week12/End of Treatment (T2DM Subgroup)</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in FPG From Baseline to Week12/End of Treatment (T2DM Subgroup)</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
          <units>mmol/L</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="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.399"/>
                    <measurement group_id="O2" value="0.51" spread="0.404"/>
                    <measurement group_id="O3" value="-0.29" spread="0.384"/>
                    <measurement group_id="O4" value="-0.65" spread="0.427"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9529</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.538</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.12</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1285</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.532</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.90</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0417</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.565</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.32</ci_lower_limit>
            <ci_upper_limit>-0.05</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Change in HbA1c From Baseline to Week12/End of Treatment (T2DM Subgroup)</title>
        <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>PXL770 250 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>PXL770 250 mg BID</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>PXL770 500 mg QD</title>
            <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c From Baseline to Week12/End of Treatment (T2DM Subgroup)</title>
          <description>Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.</description>
          <population>ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.</population>
          <units>percent</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="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.175"/>
                    <measurement group_id="O2" value="-0.04" spread="0.176"/>
                    <measurement group_id="O3" value="-0.23" spread="0.175"/>
                    <measurement group_id="O4" value="-0.44" spread="0.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3141</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.228</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0656</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.226</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.88</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0101</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.237</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.12</ci_lower_limit>
            <ci_upper_limit>-0.16</ci_upper_limit>
            <estimate_desc>Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>PXL770 250 mg QD</title>
          <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>PXL770 250 mg BID</title>
          <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>PXL770 500 mg QD</title>
          <description>Two capsules were taken BID with a glass of water at least 15 minutes before a meal in the morning and in the evening time for 12 weeks.</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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </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="8" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="6" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </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="31"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Medical Operations</name_or_title>
      <organization>Poxel</organization>
      <phone>+33 (0)4 37 37 20 10</phone>
      <email>carole.thang@poxelpharma.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/NCT03763877
org study id: PXL770-004
nct id: NCT03763877
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12
      weeks of treatment.
The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary
      endpoint will be the assessment of the change in the percentage of liver fat mass (assessed
      by MRI-PDFF).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)
time frame: Baseline to Week 12
description: MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
measure: Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)
time frame: Baseline to Week 12
description: MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
measure: Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)
time frame: Baseline to Week 12
description: MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
measure: Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])
time frame: Baseline to Week 12
description: MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
measure: Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment
time frame: Baseline to Week 12
description: MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
measure: Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment
time frame: Baseline to Week 12
description: Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF
measure: Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Total Cholesterol From Baseline to Week12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Triglycerides From Baseline to Week12/End of Treatment
time frame: Baseline to Week 12
description: Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment
time frame: Baseline to Week 12
description: Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 < 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 > 3.25: cirrhosis.
Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
measure: Change in Body Weight From Baseline to Week 12/End of Treatment
time frame: Baseline to Week 12
description: Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.
arm group label: Group 1
arm group type: Experimental
description: PXL770 Dose 1
arm group label: Group 2
arm group type: Experimental
description: PXL770 Dose 2
arm group label: Group 3
arm group type: Experimental
description: PXL770 Dose 3
arm group label: Group 4
arm group type: Placebo Comparator
description: Placebo oral capsule
intervention type: Drug
intervention name: PXL770
description: Oral capsule
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Oral capsule
arm group label: Group 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://pubmed.ncbi.nlm.nih.gov/34560015/
description: Related Info
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 