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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and confirm a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inventiva Pharma
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

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

2. Diagnosis of NASH

3. HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy.

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

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

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

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

Diabetes related:

11. Diabetes mellitus other than type 2

12. Diabetic ketoacidosis at Screening

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

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

Obesity related:

15. 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:

16. History of or current unstable cardiac dysrhythmias

17. Unstable heart failure

18. Uncontrolled hypertension

19. Stroke or transient ischemic attack

General safety:

20. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min/1.73 m2

21. Concomitant treatment with PPAR-⍺ agonists (fibrates)

22. Previous exposure to lanifibranor or empagliflozin

23. Present pregnancy/lactation

24. 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.