Lanifibranor

DRUG5 trials

Conditions

Diabetes Mellitus, Type 2Healthy SubjectsNASH - Nonalcoholic SteatohepatitisNon-alcoholic steatohepatitis (NASH)Nonalcoholic Fatty Liver Disease (NAFLD)PharmacokineticType 2 Diabetes (T2DM)

Phase 1

Multiple Ascending Dose Phase I Study in Order to Define Lanifibranor (IVA337) Supra-thjerapeutic Dose

CompletedNCT03866369

Inventiva PharmaHealthy Subjects

Start: 2019-01-17End: 2019-08-27Updated: 2019-11-01

A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects

CompletedNCT06126562

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Pharmacokinetic

Start: 2023-10-31End: 2023-12-15Updated: 2024-01-02

Phase 2

Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease

CompletedNCT03459079

University of FloridaNonalcoholic Fatty Liver Disease (NAFLD), Type 2 Diabetes (T2DM)

Start: 2018-08-14End: 2023-06-01Updated: 2024-09-19

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

CompletedNCT05232071

Inventiva PharmaNASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2

Start: 2022-06-29End: 2024-06-04Updated: 2026-09-09

Phase 3

A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patient with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

Active, not recruitingCTIS2023-508248-23-00

InventivaNon-alcoholic steatohepatitis (NASH)

Start: 2021-11-26Target: 236Updated: 2025-11-10

Related Papers

Pan-PPAR agonist lanifibranor improves insulin resistance and hepatic steatosis in patients with T2D and MASLD.

2025-01-1536 citations

From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis