A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis

• Status: Recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inventiva Pharma

Criteria

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. Stable 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): Stable dose for at least 3 months

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

3. Statins: Stable dose for at least 3 months

4. All other chronically administered drugs must be stable 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. Abnormal synthetic liver function as defined by Screening central laboratory evaluation

8. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males

9. Patient currently receiving any approved treatment for NASH or obesity

10. Current or recent history (<5 years) of significant alcohol consumption

11. 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:

12. HbA1c >9% at Screening

13. Diabetes mellitus other than type 2

14. Current treatment with insulin

15. Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs])

Obesity related:

16. 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:

17. History of heart failure with reduced left ventricular ejection fraction (LVEF)

18. Atrial fibrillation requiring anticoagulation

19. Unstable heart failure

20. Uncontrolled hypertension at Screening (values >160/100 mm Hg)

General safety:

21. Women currently breastfeeding

22. Previous exposure to lanifibranor

23. Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer

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