Trial intelligence / Profile preview

Lanifibranor Alone and With Empagliflozin in NASH and T2DM

NCT05232071Phase 2

Key facts

Status: Completed
Start: Jun 2022
Primary completion: May 2024
Countries: 5
Sponsor: Inventiva
Modality: Small Molecules

Drugs: lanifibranor
Conditions: Nonalcoholic steatohepatitis (NASH)type 2 diabetes mellitus (T2DM)

Overview

Phase 2, randomised, double-blind trial of lanifibranor in Nonalcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Inventiva. Primary endpoint: Absolute Change in HbA1c at 24 weeks. Started Jun 2022; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Lanifibranor (800 mg/day)
Lanifibranor 800 mg/day (two 400 mg tablets) QD
Matching placebo
Two lanifibranor placebo-matching tablets QD
Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day)
Lanifibranor 800 mg/day plus Empagliflozin 10 mg/day QD

Who it enrols

Adults with NASH and Type 2 Diabetes Mellitus (HbA1c 7-10%), excluding those with other liver diseases, advanced cirrhosis, or recent use of certain diabetes/obesity medications.

Endpoints

Primary

Absolute Change in HbA1c24 weeks

Secondary

Change in Liver Tests (ALT)24 weeks
Change in Liver Tests (AST)24 weeks
Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)24 weeks
Change in Insulin Resistance and Glycaemic Control (Insulin)24 weeks
Change in Insulin Resistance and Glycaemic Control (Adiponectin)24 weeks
Change in Lipid Parameters (HDL Cholesterol)24 weeks
Change in Body Weight and Body Composition (Body Weight)24 weeks
Change in Body Weight and Body Composition (VAT/SAT Ratio)24 weeks

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