A randomised double-blind placebo-controlled multicentre Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
Brief description of study
The 3 peroxisome proliferator-activated receptors (PPAR) isoforms play an important role in several components of NASH, from hepatic triglyceride accumulation to fibrosis. Lanifibranor, a pan-PPAR agonist, has demonstrated significant improvement in histological endpoints of NASH in the previous Phase 2b study in patients with highly active NASH. A positive effect of lanifibranor on glucose and lipid metabolism was also demonstrated. This suggests that lanifibranor has the potential to address histological and metabolic aspects of NASH and may be a promising candidate for its treatment. Primary Objective This Phase 3 study is conducted to evaluate Lanifibranorin 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 Lanifibranorcompared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology. Part 2 To assess the effect of Lanifibranorcompared 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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