Clinical Trials

Prescreening Criteria:

- Diagnosed with NASH on prior liver biopsy

- Type 2 diabetes with high waist circumference or obesity or hepatic steatosis on
ultrasound

- 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 the
Steatosis-Activity-Fibrosis (SAF):

1. Steatosis score ≥1

2. Activity score: A3 or A4

3. Fibrosis score: F2 or F3

3. No qualitative change in dose for the drugs listed below:

1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1
receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2
inhibitors): for at least 3 months

2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months

3. Statins: for at least 3 months

4. No qualitative change in dose for all other chronically administered drugs for at
least 3 months prior to Screening

5. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy
and Baseline (no more than 5% change for both periods)

6. Negative serum pregnancy test at study Screening for females of childbearing potential
confirmed by central laboratory. Females of childbearing potential must practice a
consistent and proper use of highly effective method of contraception throughout the
study 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 laboratory
evaluation

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 before
screening or historical biopsy.

Obesity related:

17. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to
the qualifying liver biopsy; malabsorptive procedures and procedures combining both
restrictive and malabsorptive methods are not allowed within 5 years of the qualifying
liver 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 3
months from Screening or 5 half-lives from Screening, whichever is longer

25. Concomitant treatment with PPAR-alpha agonists (fibrates)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/22/23. Questions regarding updates should be directed to the study team contact.