Clinical Trials

Inclusion Criteria:

1. Male or female, aged ≥ 18 years at the time of signing informed consent

2. Diagnosis of NASH, based on histology or ct1>875msecs by LiverMuliScan at screening

3. HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months

4. Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.

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. Documented history of human immunodeficiency virus (HIV) infection

6. ALT or AST > 5 × upper limit of normal (ULN)

7. Abnormal liver function as defined by central laboratory evaluation:

Albumin < LLN INR ≥ 1.3 (unless patient is on anticoagulants)

Total bilirubin level ≥ 1.3 mg/dL (22.2 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is within normal reference
range)

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

9. WBC < LLN

10. Platelet count < 150,000/µL

11. ALP > 2 × ULN

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

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

14. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.

Diabetes related:

15. Diabetes mellitus other than type 2

16. Diabetic ketoacidosis at Screening

17. Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening

18. Patients on pioglitazone in the last 12 months prior to Screening. Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, or other chronic
medications with known adverse effects on glucose tolerance levels, unless on stable doses in last 3 months

Obesity related:

19. BMI>45 kg/m2 at screening

20. Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12 months prior to Screening or planned bariatric surgery through Week 24.

Cardiovascular related:

21. History of or current unstable cardiac dysrhythmias

22. Unstable heart failure

23. Uncontrolled hypertension

24. Stroke or transient ischemic attack

General safety:

25. Significant systemic or major illnesses other than liver disease and pulmonary disease, organ transplantation, serious psychiatric disease, that, in the opinion of the investigator, would preclude treatment with lanifibranor and/or adequate follow up

26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min

27. Concomitant treatment with PPAR-? agonists (fibrates)

28. Have a known hypersensitivity to any of the IMPs

29. Previous exposure to lanifibranor or empagliflozin

30. Present pregnancy/lactation

31. Metallic implant of any sort that prevents MRI examination

32. Participation in any clinical trial of an approved or non approved investigational medicinal product/device within 3 months from Screening or five half-lives of the
investigational drug from Screening.

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

Eligibility last updated 5/8/23. Questions regarding updates should be directed to the study team contact.