NCT05232071

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

A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Inventiva Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• NASH - Nonalcoholic Steatohepatitis
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	IVA337	800 mg
DRUG	Placebo	Placebo to match
DRUG	Empagliflozin	10 mg

Timeline

• Start date: 2022-06-29
• Primary completion: 2024-03-30
• Completion: 2024-06-04
• First posted: 2022-02-09
• Last updated: 2024-07-09

Locations

42 sites across 5 countries: United States, Belgium, France, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study