<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/NCT03008070</url>
  </required_header>
  <id_info>
    <org_study_id>IVA_01_337_HNAS_16_002</org_study_id>
    <secondary_id>2016-001979-70</secondary_id>
    <nct_id>NCT03008070</nct_id>
  </id_info>
  <brief_title>Phase 2b Study in NASH to Assess IVA337</brief_title>
  <acronym>NATIVE</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inventiva Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inventiva Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may&#xD;
      progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes&#xD;
      mellitus, or insulin resistance and is very common. However, Treatment of NASH is a&#xD;
      significant unmet clinical need.&#xD;
&#xD;
      IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated&#xD;
      receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and&#xD;
      fibrotic.&#xD;
&#xD;
      The purpose of this research is to evaluate the efficacy and the safety of two doses of&#xD;
      IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver&#xD;
      steatosis and moderate to severe necroinflammation without cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized (stratified on diabetes), placebo-controlled, double-blind, parallel-assignment,&#xD;
      dose-range multicenter study&#xD;
&#xD;
      There are 3 parallel treatment groups: placebo, IVA337 800mg once a day (Quaque Die, QD) and&#xD;
      IVA337 1200mg QD (identical tablets of 400mg IVA337 or placebo). Both, patient and&#xD;
      investigator are blinded.&#xD;
&#xD;
      For each patient, the study duration will be an overall of 6 to 8 months (with a 10-day to&#xD;
      4-week selection period, a 24-week treatment period and a 4-week follow-up period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">March 16, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 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>SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)</measure>
    <time_frame>24 weeks</time_frame>
    <description>SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score.&#xD;
No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NASH Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>NASH improvement is defined as a decrease of at least 2 points in NAS score (sum of CRN Steatosis, Inflammation and Ballooning scores) without worsening of CRN Fibrosis score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NASH Resolution and no Worsening of Fibrosis</measure>
    <time_frame>24 weeks</time_frame>
    <description>Resolution of NASH is defined as a CRN Inflammation score equal to 0 or 1, and a CRN Ballooning score equal to 0. No worsening of fibrosis means that the CRN fibrosis score remains stable or decreases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement of fibrosis is defined as a decrease of at least one stage in CRN Fibrosis score. No worsening of NASH is defined as no increase of CRN Steatosis score, no increase of CRN Inflammation score ans no increase of CRN Ballooning score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity (SAF-A) Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score. Improvement of SAF-A is defined as a decrease of at least 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steatosis (CRN-S) Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement of CRN Steatosis score (CRN-S) is defined as a decrease of at least 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lobular Inflammation (CRN-I) Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement of CRN Lobular inflammation score (CRN-I) is defined as a decrease of at least 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatocyte Balooning (CRN-B) Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement of CRN Ballooning (CRN-B) is defined as a decrease of at least 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibrosis (CRN-F) Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement of CRN Fibrosis score (CRN-F) is defined as a decrease of at least 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified ISHAK Fibrosis (ISHAK-F) Improvement</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement of Modified ISHAK Fibrosis (ISHAK-F) is defined as a decrease of at least 1 point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in ALT</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in AST</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in GGT</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Fibrinogen</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Hs-CRP</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Alpha2 Macroglobulin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Haptoglobulin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change of Fasting Plasma Glucose</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Insulin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in HOMA Index</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in HbA1c</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Total Cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change of HDL-Cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change of LDL-Cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Triglycerides</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Apo A1</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Adiponectin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage</measure>
    <time_frame>From baseline to Week 24.</time_frame>
    <description>Resolution of NASH is defined as a CRN Inflammation score equel to 0 or 1, and a CRN ballooning score equal to 0. Improvement of firbosis is defined as a decrease of at least one stage in CRN Fibrosis score.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">247</enrollment>
  <condition>Non-Alcoholic Steatohepatitis (NASH)</condition>
  <arm_group>
    <arm_group_label>IVA337 1200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IVA337 400mg, once a day (Quaque Die, QD) with food</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IVA337 800mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IVA337 400mg, once a day (Quaque Die, QD) with food</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to match, once a day (Quaque Die, QD) with food</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IVA337</intervention_name>
    <description>1200mg</description>
    <arm_group_label>IVA337 1200mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IVA337</intervention_name>
    <description>800mg</description>
    <arm_group_label>IVA337 800mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult subjects, age ≥18 years.&#xD;
&#xD;
          -  NASH histological diagnosis according to the currently accepted definition of both&#xD;
             EASL and AASLD, requiring the combined presence of steatosis (any degree ≥ 5%) +&#xD;
             lobular inflammation of any degree + liver cell ballooning of any amount, on a liver&#xD;
             biopsy performed ≤ 6 months before screening in the study or at screening and&#xD;
             confirmed by central reading during the screening period and&#xD;
&#xD;
               -  SAF Activity score of 3 or 4 (&gt;2)&#xD;
&#xD;
               -  SAF Steatosis score ≥ 1&#xD;
&#xD;
               -  SAF Fibrosis score &lt; 4&#xD;
&#xD;
          -  Subject agrees to have a liver biopsy performed after 24 weeks of treatment.&#xD;
&#xD;
          -  Compensated liver disease&#xD;
&#xD;
          -  No other causes of chronic liver disease (autoimmune, primary biliary cholangitis,&#xD;
             Hepatitis B virus (HBV), hepatitis C virus (HCV), Wilson's, α-1-antitrypsin&#xD;
             deficiency, hemochromatosis, etc…).&#xD;
&#xD;
          -  If applicable, have a stable type 2 diabetes, defined as HbA1c ≤ 8.5% and fasting&#xD;
             glycemia &lt;10 mmol/L, no changes in medication in the previous 6 months, and no new&#xD;
             symptoms associated with decompensated diabetes in the previous 3 months.&#xD;
&#xD;
          -  Have a stable weight since the liver biopsy was performed defined by no more than a 5&#xD;
             % loss of initial body weight.&#xD;
&#xD;
          -  Negative pregnancy test or post-menopausal. Women with childbearing potential (i.e.&#xD;
             fertile, following menarche and until becoming post-menopausal unless permanently&#xD;
             sterile) must be using a highly effective method of contraception (i.e. combined&#xD;
             (estrogen and progestogen containing) hormonal/ progestogen-only hormonal&#xD;
             contraception associated with inhibition of ovulation, intrauterine device,&#xD;
             intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised&#xD;
             partner). The contraceptive method will have to be followed for at least one&#xD;
             menstruation cycle after the end of the study&#xD;
&#xD;
          -  Subjects having given her/his written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of another form of liver disease.&#xD;
&#xD;
          -  History of sustained excess alcohol ingestion: daily alcohol consumption &gt; 30 g/day (3&#xD;
             drinks per day) for males and &gt; 20 g/day (2 drinks per day) for females.&#xD;
&#xD;
          -  Unstable metabolic condition: Weight change &gt; 5kg in the last three months, diabetes&#xD;
             with poor glycemic control (HbA1c &gt; 8.5%), introduction of an antidiabetic or of an&#xD;
             anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the&#xD;
             past 6 months prior to screening.&#xD;
&#xD;
          -  History of gastrointestinal malabsorptive bariatric surgery within less than 5 years&#xD;
             or ingestion of drugs known to produce hepatic steatosis including corticosteroids,&#xD;
             high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6&#xD;
             months.&#xD;
&#xD;
          -  Significant systemic or major illnesses other than liver disease, including congestive&#xD;
             heart failure (class C and D of the American Heart Association , AHA), unstable&#xD;
             coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure,&#xD;
             organ transplantation, serious psychiatric disease, malignancy that, in the opinion of&#xD;
             the investigator, would preclude treatment with IVA337 and/or adequate follow up.&#xD;
&#xD;
          -  HB antigen &gt;0, HCV Polymerase chain reaction (PCR) tests &gt;0 (patients with a history&#xD;
             of HCV infection can be included if HCV PCR is negative since more than 3 years), HIV&#xD;
             infection.&#xD;
&#xD;
          -  Pregnancy/lactation or inability to adhere to adequate contraception in women of&#xD;
             child-bearing potential.&#xD;
&#xD;
          -  Active malignancy except cutaneous basocellular carcinoma.&#xD;
&#xD;
          -  Any other condition which, in the opinion of the investigator would impede competence&#xD;
             or compliance or possibly hinder completion of the study.&#xD;
&#xD;
          -  Body mass index (BMI) &gt;45 kg/m2.&#xD;
&#xD;
          -  Type 1 diabetes and type 2 diabetic patient on insulin.&#xD;
&#xD;
          -  Diabetic ketoacidosis&#xD;
&#xD;
          -  Fasting Triglycerides &gt; 300 mg/dL.&#xD;
&#xD;
          -  Hemostasis disorders or current treatment with anticoagulants.&#xD;
&#xD;
          -  Contra-indication to liver biopsy.&#xD;
&#xD;
          -  History of, or current cardiac dysrhythmias and/or a history of cardiovascular disease&#xD;
             event, including myocardial infarction, except patients with only well controlled&#xD;
             hypertension. Any clinically significant ECG abnormality reported by central ECG&#xD;
             reading.&#xD;
&#xD;
          -  Participation in any other clinical study within the previous 3 months.&#xD;
&#xD;
          -  Have a known hypersensitivity to any of the ingredients or excipients of the&#xD;
             Investigational medicinal product (IMP)&#xD;
&#xD;
          -  Be possibly dependent on the Investigator or the sponsor (e.g., including, but not&#xD;
             limited to, affiliated employee).&#xD;
&#xD;
          -  Creatine phosphokinase (CPK)&gt;5 x ULN&#xD;
&#xD;
          -  Osteopenia or any other well documented Bone disease. Patient without well documented&#xD;
             osteopenia treated with vitamin D and/or Calcium based supplements for preventive&#xD;
             reasons can be included.&#xD;
&#xD;
        (The criteria below are applicable only for patients who will undergo a MRI/LMS in selected&#xD;
        centers)&#xD;
&#xD;
          -  Claustrophobia to a degree that prevents tolerance of MRI scanning procedure. Sedation&#xD;
             is permitted at discretion of investigator.&#xD;
&#xD;
          -  Metallic implant of any sort that prevents MRI examination including, but not limited&#xD;
             to: aneurysm clips, metallic foreign body, vascular grafts or cardiac implants, neural&#xD;
             stimulator, metallic contraceptive device, tattoo, body piercing that cannot be&#xD;
             removed, cochlear implant; or any other contraindication to MRI examination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven FRANCQUE, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Alabama GI Research Center</name>
      <address>
        <city>Madison</city>
        <state>Alabama</state>
        <zip>35758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACTRI</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Research, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Digestive Health Specialists, LLP</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast GI Research Division</name>
      <address>
        <city>Concord</city>
        <state>Massachusetts</state>
        <zip>29027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina's Center for Liver Disease/CHG</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson University hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Research, LLC</name>
      <address>
        <city>Hermitage</city>
        <state>Tennessee</state>
        <zip>37076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Texas Liver Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Research, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre Department of Hepatology</name>
      <address>
        <city>Bedford Park</city>
        <zip>SA 5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyell McEwin Hospital &amp; The University of Adelaide</name>
      <address>
        <city>Elizabeth Vale</city>
        <zip>SA 5112</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <zip>WA 6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Universitaire Saint-luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost Limburg</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;DCC Alexandrovska&quot;, EOOD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic Tokuda Hospital</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic University Hospital EOOD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Sveta Anna&quot; Sofia</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy - MHAT</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Sv. Ivan Rilski&quot;</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Tsaritsa Yoanna-ISUL&quot;</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Bailey Health Clinic</name>
      <address>
        <city>Edmonton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CISSS de la Montérégie Centre</name>
      <address>
        <city>Greenfield Park</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Western Ontario, London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre (MUHC)</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medpharmgene, Inc</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAIR Centre</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Researchsite S.R.O.</name>
      <address>
        <city>Plzen</city>
        <zip>30100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klin Med S.R.O.</name>
      <address>
        <city>Praha</city>
        <zip>1200</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut klinické a experimentální medicíny, IKEM</name>
      <address>
        <city>Praha</city>
        <zip>14021</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Besançon</name>
      <address>
        <city>Besancon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de La Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional Universitaire de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Purpan - Centre Hospitalier Universitaire (CHU) de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RWTH University Hospital</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innere Medizin II - Universitätsklinik Freiburg</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinischen Klinik IV</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mainz, I. Med. Klinik</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Würzburg</name>
      <address>
        <city>Wurzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti di Ancona-Università Politecnica delle Marche</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Granda Ospedale Maggiore Policlinico - Università di Milano</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pol. Giaccone</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliambulatorio Giovanni Paolo II</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Research</name>
      <address>
        <city>Quatre Bornes</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Gastroenterologii Hepatologii UCK</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katedra i Klinika Chorób Zakaźnych i Hepatologii Uniwersytetu Medycznego w Łodzi</name>
      <address>
        <city>Lodz</city>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Chorób Zakaźnych</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General hospital Celje</name>
      <address>
        <city>Celje</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Murska Sobota</name>
      <address>
        <city>Murska Sobota</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro MAJADAHONDA</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virgen de la Victoria University Hospital</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Viszerale Chirurgie und Medizin</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epatocentro Ticino</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital, Newcastle University</name>
      <address>
        <city>Newcastle</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Mauritius</country>
    <country>Poland</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Réunion</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>March 16, 2021</results_first_submitted>
  <results_first_submitted_qc>March 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 12, 2021</results_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-Alcoholic Steatohepatitis</keyword>
  <keyword>NASH</keyword>
  <keyword>peroxisome proliferator-activated receptor (PPAR)</keyword>
  <keyword>Liver Diseases</keyword>
  <keyword>Fibrosis</keyword>
  <keyword>Fatty Liver</keyword>
  <keyword>Non-alcoholic Fatty Liver Disease</keyword>
  <keyword>Digestive System Diseases</keyword>
  <keyword>IVA337</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <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 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03008070/Prot_002.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>May 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03008070/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment of patients started in February 2017, and last patient was recruited on March 2019. A total of 868 patients were screened for the study.</recruitment_details>
      <pre_assignment_details>Patients were invited to participate into the study by their referent doctor according to the patient's medical records. Patients had to fulfil all the inclusion and none of the exclusion criteria to be eligible.&#xD;
A total of 247 patients were randomised, and 621 were not randomised.Main reason for non randomization was inclusion/exclusion criteria not met (470 - 76%).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lanifibranor 1200mg</title>
          <description>Lanifibranor 400mg, once a day (Quaque Die, QD) with food&#xD;
Lanifibranor: 1200mg</description>
        </group>
        <group group_id="P2">
          <title>Lanifibranor 800mg</title>
          <description>Lanifibranor 400mg, once a day (Quaque Die, QD) with food&#xD;
Lanifibranor: 800mg</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="83"/>
                <participants group_id="P3" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by patient and adverse event non fatal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Use of prohibited drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IVA337 1200mg</title>
          <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
        </group>
        <group group_id="B2">
          <title>IVA337 800mg</title>
          <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="83"/>
            <count group_id="B2" value="83"/>
            <count group_id="B3" value="81"/>
            <count group_id="B4" value="247"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.2" spread="13.8"/>
                    <measurement group_id="B2" value="55" spread="10.4"/>
                    <measurement group_id="B3" value="53.4" spread="13.1"/>
                    <measurement group_id="B4" value="53.6" spread="12.5"/>
                  </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="49"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="74"/>
                    <measurement group_id="B4" value="232"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mauritius</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <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="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)</title>
        <description>SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score.&#xD;
No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)</title>
          <description>SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score.&#xD;
No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 800 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).&#xD;
The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.061</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 1200 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).&#xD;
The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.004</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.24</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NASH Improvement</title>
        <description>NASH improvement is defined as a decrease of at least 2 points in NAS score (sum of CRN Steatosis, Inflammation and Ballooning scores) without worsening of CRN Fibrosis score.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>NASH Improvement</title>
          <description>NASH improvement is defined as a decrease of at least 2 points in NAS score (sum of CRN Steatosis, Inflammation and Ballooning scores) without worsening of CRN Fibrosis score.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NASH Resolution and no Worsening of Fibrosis</title>
        <description>Resolution of NASH is defined as a CRN Inflammation score equal to 0 or 1, and a CRN Ballooning score equal to 0. No worsening of fibrosis means that the CRN fibrosis score remains stable or decreases.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>NASH Resolution and no Worsening of Fibrosis</title>
          <description>Resolution of NASH is defined as a CRN Inflammation score equal to 0 or 1, and a CRN Ballooning score equal to 0. No worsening of fibrosis means that the CRN fibrosis score remains stable or decreases.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH</title>
        <description>Improvement of fibrosis is defined as a decrease of at least one stage in CRN Fibrosis score. No worsening of NASH is defined as no increase of CRN Steatosis score, no increase of CRN Inflammation score ans no increase of CRN Ballooning score.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH</title>
          <description>Improvement of fibrosis is defined as a decrease of at least one stage in CRN Fibrosis score. No worsening of NASH is defined as no increase of CRN Steatosis score, no increase of CRN Inflammation score ans no increase of CRN Ballooning score.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activity (SAF-A) Improvement</title>
        <description>SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score. Improvement of SAF-A is defined as a decrease of at least 1 point.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Activity (SAF-A) Improvement</title>
          <description>SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score. Improvement of SAF-A is defined as a decrease of at least 1 point.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steatosis (CRN-S) Improvement</title>
        <description>Improvement of CRN Steatosis score (CRN-S) is defined as a decrease of at least 1 point.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Steatosis (CRN-S) Improvement</title>
          <description>Improvement of CRN Steatosis score (CRN-S) is defined as a decrease of at least 1 point.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lobular Inflammation (CRN-I) Improvement</title>
        <description>Improvement of CRN Lobular inflammation score (CRN-I) is defined as a decrease of at least 1 point.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Lobular Inflammation (CRN-I) Improvement</title>
          <description>Improvement of CRN Lobular inflammation score (CRN-I) is defined as a decrease of at least 1 point.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hepatocyte Balooning (CRN-B) Improvement</title>
        <description>Improvement of CRN Ballooning (CRN-B) is defined as a decrease of at least 1 point.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Hepatocyte Balooning (CRN-B) Improvement</title>
          <description>Improvement of CRN Ballooning (CRN-B) is defined as a decrease of at least 1 point.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fibrosis (CRN-F) Improvement</title>
        <description>Improvement of CRN Fibrosis score (CRN-F) is defined as a decrease of at least 1 point.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Fibrosis (CRN-F) Improvement</title>
          <description>Improvement of CRN Fibrosis score (CRN-F) is defined as a decrease of at least 1 point.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified ISHAK Fibrosis (ISHAK-F) Improvement</title>
        <description>Improvement of Modified ISHAK Fibrosis (ISHAK-F) is defined as a decrease of at least 1 point.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Modified ISHAK Fibrosis (ISHAK-F) Improvement</title>
          <description>Improvement of Modified ISHAK Fibrosis (ISHAK-F) is defined as a decrease of at least 1 point.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in ALT</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in ALT</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.54" spread="3.82"/>
                    <measurement group_id="O2" value="-26.08" spread="3.85"/>
                    <measurement group_id="O3" value="-1.4" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in AST</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in AST</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.04" spread="3.17"/>
                    <measurement group_id="O2" value="-15.11" spread="3.2"/>
                    <measurement group_id="O3" value="-0.08" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in GGT</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in GGT</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.87" spread="5.57"/>
                    <measurement group_id="O2" value="-43.38" spread="5.61"/>
                    <measurement group_id="O3" value="4.41" spread="5.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Fibrinogen</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Fibrinogen</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.81"/>
                    <measurement group_id="O2" value="-0.10" spread="0.61"/>
                    <measurement group_id="O3" value="0.02" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Hs-CRP</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Hs-CRP</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.37" spread="0.46"/>
                    <measurement group_id="O2" value="-2.05" spread="0.47"/>
                    <measurement group_id="O3" value="0.11" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Alpha2 Macroglobulin</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Alpha2 Macroglobulin</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.38"/>
                    <measurement group_id="O2" value="0.15" spread="0.40"/>
                    <measurement group_id="O3" value="0.05" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Haptoglobulin</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Haptoglobulin</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.</description>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.099" spread="0.378"/>
                    <measurement group_id="O2" value="-0.053" spread="0.256"/>
                    <measurement group_id="O3" value="0.074" spread="0.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change of Fasting Plasma Glucose</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change of Fasting Plasma Glucose</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.12"/>
                    <measurement group_id="O2" value="-0.78" spread="0.12"/>
                    <measurement group_id="O3" value="0.24" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Insulin</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Insulin</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-114.91" spread="11.75"/>
                    <measurement group_id="O2" value="-118.66" spread="11.66"/>
                    <measurement group_id="O3" value="-35.7" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in HOMA Index</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in HOMA Index</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.46" spread="0.58"/>
                    <measurement group_id="O2" value="-5.79" spread="0.58"/>
                    <measurement group_id="O3" value="-1.47" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in HbA1c</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in HbA1c</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" spread="0.05"/>
                    <measurement group_id="O2" value="-0.38" spread="0.05"/>
                    <measurement group_id="O3" value="0.07" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Total Cholesterol</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Total Cholesterol</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.07"/>
                    <measurement group_id="O2" value="-0.02" spread="0.08"/>
                    <measurement group_id="O3" value="0.01" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change of HDL-Cholesterol</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change of HDL-Cholesterol</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.02"/>
                    <measurement group_id="O2" value="0.16" spread="0.02"/>
                    <measurement group_id="O3" value="0.01" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change of LDL-Cholesterol</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change of LDL-Cholesterol</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.07"/>
                    <measurement group_id="O2" value="0.03" spread="0.07"/>
                    <measurement group_id="O3" value="0.01" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Triglycerides</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Triglycerides</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="0.09"/>
                    <measurement group_id="O2" value="-0.49" spread="0.09"/>
                    <measurement group_id="O3" value="0.06" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Apo A1</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Apo A1</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.39" spread="2.16"/>
                    <measurement group_id="O2" value="-0.29" spread="2.19"/>
                    <measurement group_id="O3" value="0.03" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Adiponectin</title>
        <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IVA337 1200mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>IVA337 800mg</title>
            <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Adiponectin</title>
          <description>Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.</description>
          <units>microgram/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.12" spread="1.44"/>
                    <measurement group_id="O2" value="11.95" spread="1.51"/>
                    <measurement group_id="O3" value="-0.35" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage</title>
        <description>Resolution of NASH is defined as a CRN Inflammation score equel to 0 or 1, and a CRN ballooning score equal to 0. Improvement of firbosis is defined as a decrease of at least one stage in CRN Fibrosis score.</description>
        <time_frame>From baseline to Week 24.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lanifibranor 1200mg</title>
            <description>Lanifibranor 400mg, once a day (Quaque Die, QD) with food&#xD;
Lanifibranor: 1200mg</description>
          </group>
          <group group_id="O2">
            <title>Lanifibranor 800mg</title>
            <description>Lanifibranor 400mg, once a day (Quaque Die, QD) with food&#xD;
Lanifibranor: 800mg</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
          </group>
        </group_list>
        <measure>
          <title>Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage</title>
          <description>Resolution of NASH is defined as a CRN Inflammation score equel to 0 or 1, and a CRN ballooning score equal to 0. Improvement of firbosis is defined as a decrease of at least one stage in CRN Fibrosis score.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On or after the first dose of treatment up to 30 days post last dose.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IVA337 1200mg</title>
          <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 1200mg</description>
        </group>
        <group group_id="E2">
          <title>IVA337 800mg</title>
          <description>IVA337 400mg, once a day (Quaque Die, QD) with food&#xD;
IVA337: 800mg</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo to match, once a day (Quaque Die, QD) with food&#xD;
Placebo: Placebo to match</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumobilia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Undifferentiated connective tissue disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Foot operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="60" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="83"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="83"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="83"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="83"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="83"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="83"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="83"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="83"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="83"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="83"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="83"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="83"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="83"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="81"/>
              </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>Dr Michael Cooreman, Chief Medical Officer</name_or_title>
      <organization>Inventiva S.A.</organization>
      <phone>+33380447616</phone>
      <email>native.public@inventivapharma.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/NCT03008070
org study id: IVA_01_337_HNAS_16_002
secondary id: 2016-001979-70
nct id: NCT03008070
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may
      progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes
      mellitus, or insulin resistance and is very common. However, Treatment of NASH is a
      significant unmet clinical need.

      IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated
      receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and
      fibrotic.

      The purpose of this research is to evaluate the efficacy and the safety of two doses of
      IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver
      steatosis and moderate to severe necroinflammation without cirrhosis.
Randomized (stratified on diabetes), placebo-controlled, double-blind, parallel-assignment,
      dose-range multicenter study

      There are 3 parallel treatment groups: placebo, IVA337 800mg once a day (Quaque Die, QD) and
      IVA337 1200mg QD (identical tablets of 400mg IVA337 or placebo). Both, patient and
      investigator are blinded.

      For each patient, the study duration will be an overall of 6 to 8 months (with a 10-day to
      4-week selection period, a 24-week treatment period and a 4-week follow-up period).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)
time frame: 24 weeks
description: SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score.
No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
measure: NASH Improvement
time frame: 24 weeks
description: NASH improvement is defined as a decrease of at least 2 points in NAS score (sum of CRN Steatosis, Inflammation and Ballooning scores) without worsening of CRN Fibrosis score.
measure: NASH Resolution and no Worsening of Fibrosis
time frame: 24 weeks
description: Resolution of NASH is defined as a CRN Inflammation score equal to 0 or 1, and a CRN Ballooning score equal to 0. No worsening of fibrosis means that the CRN fibrosis score remains stable or decreases.
measure: Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH
time frame: 24 weeks
description: Improvement of fibrosis is defined as a decrease of at least one stage in CRN Fibrosis score. No worsening of NASH is defined as no increase of CRN Steatosis score, no increase of CRN Inflammation score ans no increase of CRN Ballooning score.
measure: Activity (SAF-A) Improvement
time frame: 24 weeks
description: SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score. Improvement of SAF-A is defined as a decrease of at least 1 point.
measure: Steatosis (CRN-S) Improvement
time frame: 24 weeks
description: Improvement of CRN Steatosis score (CRN-S) is defined as a decrease of at least 1 point.
measure: Lobular Inflammation (CRN-I) Improvement
time frame: 24 weeks
description: Improvement of CRN Lobular inflammation score (CRN-I) is defined as a decrease of at least 1 point.
measure: Hepatocyte Balooning (CRN-B) Improvement
time frame: 24 weeks
description: Improvement of CRN Ballooning (CRN-B) is defined as a decrease of at least 1 point.
measure: Fibrosis (CRN-F) Improvement
time frame: 24 weeks
description: Improvement of CRN Fibrosis score (CRN-F) is defined as a decrease of at least 1 point.
measure: Modified ISHAK Fibrosis (ISHAK-F) Improvement
time frame: 24 weeks
description: Improvement of Modified ISHAK Fibrosis (ISHAK-F) is defined as a decrease of at least 1 point.
measure: Absolute Change in ALT
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change in AST
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change in GGT
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change in Fibrinogen
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change in Hs-CRP
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change in Alpha2 Macroglobulin
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change in Haptoglobulin
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
measure: Absolute Change of Fasting Plasma Glucose
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in Insulin
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in HOMA Index
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in HbA1c
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in Total Cholesterol
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change of HDL-Cholesterol
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change of LDL-Cholesterol
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in Triglycerides
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in Apo A1
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Absolute Change in Adiponectin
time frame: 24 weeks
description: Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
measure: Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage
time frame: From baseline to Week 24.
description: Resolution of NASH is defined as a CRN Inflammation score equel to 0 or 1, and a CRN ballooning score equal to 0. Improvement of firbosis is defined as a decrease of at least one stage in CRN Fibrosis score.
arm group label: IVA337 1200mg
arm group type: Experimental
description: IVA337 400mg, once a day (Quaque Die, QD) with food
arm group label: IVA337 800mg
arm group type: Experimental
description: IVA337 400mg, once a day (Quaque Die, QD) with food
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo to match, once a day (Quaque Die, QD) with food
intervention type: Drug
intervention name: IVA337
description: 1200mg
arm group label: IVA337 1200mg
intervention type: Drug
intervention name: IVA337
description: 800mg
arm group label: IVA337 800mg
intervention type: Drug
intervention name: Placebo
description: Placebo to match
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sven FRANCQUE, MD, PhD
role: Principal Investigator
affiliation: Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
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country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Czechia
country: France
country: Germany
country: Italy
country: Mauritius
country: Poland
country: Slovenia
country: Spain
country: Switzerland
country: United Kingdom
country: United States
country: Czech Republic
country: Netherlands
country: Portugal
country: Réunion
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
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