Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

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≥875ms assessed by LiverMultiScan orcT1≥825ms assessed by LiverMultiScan and hepatic fat content ≥ 10% assessed byMRI-PDFF at screening

3. HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/ordipeptidyl 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 atleast 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 ≥ 1.5 mg/dL (25.7 µmol/L) (patients with a documented history of Gilbert's syndromecan be enrolled if direct bilirubin is ≤ 0.45 mg/dL (7.7 μmol/L) )

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

9. WBC < LLN. A lower count is acceptable in patients with benign ethnic neutropenia,if considered to be clinical insignificant by the investigator

10. Platelet count < 140,000/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 toScreening. 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), insulinor sulfonylurea or treatment within the last 3 months prior to Screening

18. Patients on pioglitazone in the last 12 months prior to Screening.

19. Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, orother chronic medications with known adverse effects on glucose tolerance levels,unless on stable doses in last 3 months Obesity related:

20. BMI>45 kg/m2 at screening

21. Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12months 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 pulmonarydisease, organ transplantation, serious psychiatric disease, that, in the opinion ofthe investigator, would preclude treatment with lanifibranor and/or adequate followup 26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR)value < 60 mL/min 27. Concomitant treatment with PPAR-⍺ agonists (fibrates) 28.Patients on Vitamin E at doses ≥ 400 IU/day; doses of ≥ 400 IU/day are allowed whenno qualitative change in dose for 6 months prior to Screening 29. Have a knownhypersensitivity to any of the IMPs 30. Previous exposure to lanifibranor orempagliflozin 31. Present pregnancy/lactation 32. Metallic implant of any sort thatprevents MRI examination 33. Participation in any clinical trial of an approved ornon approved investigational medicinal product/device within 3 months from Screeningor five half-lives of the investigational drug from Screening.