drugset / Trial / NCT02704403

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

NCT02704403

Phase 3 Terminated 2157 enrolled Genfit
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Timeline

Start
2016-03
Primary completion
2020-10-28
Completion
2020-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Elafibranor Small molecule 120 mg Oral