A randomized, double-blind, placebo-controlled, multicenter, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2/fibrosis 3 stage of liver fibrosis

Investigator: David Victor, MD

Study Coordinator:

Status: Enrolling

ClinicalTrials.gov Number: NCT04849728

Phone:

Protocol Number: PRO00031950

Description

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3. NASH - Nonalcoholic Steatohepatitis - Drug: IVA337 vs Drug: Placebo This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2, with the following primary objectives: Part 1 To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology. Part 2 To assess the effect of lanifibranor compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, or all-cause death.
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