A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

Prescreening Criteria:

• Diagnosed with NASH on prior liver biopsy
• Type 2 diabetes with high waist circumference or obesity or hepatic steatosis onultrasound
• At least 3 of the components of metabolic syndrome Inclusion Criteria:

1. Male or female, aged ≥18 years at the time of signing informed consent
2. Upon central biopsy reading process: diagnosis of NASH according to theSteatosis-Activity-Fibrosis (SAF):
3. Steatosis score ≥1
4. Activity score: A3 or A4
5. Fibrosis score: F2 or F3
6. No qualitative change in dose for the drugs listed below:
7. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2inhibitors): for at least 3 months
8. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
9. Statins: for at least 3 months
10. No qualitative change in dose for all other chronically administered drugs for atleast 3 months prior to Screening
11. Weight stable for 6 months prior to Screening and between the qualifying liver biopsyand Baseline (no more than 5% change for both periods)
12. Negative serum pregnancy test at study Screening for females of childbearing potentialconfirmed by central laboratory. Females of childbearing potential must practice aconsistent and proper use of highly effective method of contraception throughout thestudy and for 1 month after treatment discontinuation.

Exclusion Criteria: Liver-related:

1. Documented causes of chronic liver disease other than NASH
2. Histologically documented liver cirrhosis (fibrosis stage F4)
3. History or current diagnosis of hepatocellular carcinoma (HCC)
4. History of or planned liver transplant
5. Positive human immunodeficiency virus (HIV) serology
6. ALT or AST >5 × ULN
7. AST<0.6 ULN if the liver biopsy has to be performed in the scope of the study
8. Abnormal synthetic liver function as defined by Screening central laboratoryevaluation
9. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males
10. Patient currently receiving any approved treatment for NASH or obesity
11. Current or recent history (<5 years) of significant alcohol consumption
12. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD)administered for at least 2 weeks within 12 months prior to qualifying liver biopsy Glycaemia related:
13. HbA1c >9% at Screening
14. Diabetes mellitus other than type 2
15. Current treatment with insulin
16. Treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 12 months beforescreening or historical biopsy. Obesity related:
17. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior tothe qualifying liver biopsy; malabsorptive procedures and procedures combining bothrestrictive and malabsorptive methods are not allowed within 5 years of the qualifyingliver biopsy. Cardiovascular related:
18. History of heart failure with reduced left ventricular ejection fraction (LVEF)
19. Atrial fibrillation requiring anticoagulation
20. Unstable heart failure
21. Uncontrolled hypertension at Screening (values >160/100 mm Hg) General safety:
22. Women currently breastfeeding
23. Previous exposure to lanifibranor
24. Participation in any clinical trial investigational medicinal product/device within 3months from Screening or 5 half-lives from Screening, whichever is longer
25. Concomitant treatment with PPAR-alpha agonists (fibrates)