NCT03008070

Phase 2b Study in NASH to Assess IVA337

A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Inventiva Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.

Detailed description

Randomized (stratified on diabetes), placebo-controlled, double-blind, parallel-assignment, dose-range multicenter study There are 3 parallel treatment groups: placebo, IVA337 800mg once a day (Quaque Die, QD) and IVA337 1200mg QD (identical tablets of 400mg IVA337 or placebo). Both, patient and investigator are blinded. For each patient, the study duration will be an overall of 6 to 8 months (with a 10-day to 4-week selection period, a 24-week treatment period and a 4-week follow-up period).

Conditions

• Non-Alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	IVA337	1200mg
DRUG	IVA337	800mg
DRUG	Placebo	Placebo to match

Timeline

• Start date: 2017-02-07
• Primary completion: 2020-02-20
• Completion: 2020-03-16
• First posted: 2017-01-02
• Last updated: 2023-07-19
• Results posted: 2021-04-12

Locations

85 sites across 16 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Italy, Mauritius, Poland, Slovenia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study