Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
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
Outcome
Missed primary endpoint
Stopped: “Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified”
registry analysis (superiority test); 120 mg Elafibranor vs Placebo; p = 0.0659; Mean Difference (Net) 0.043 (95% CI -0.003 to 0.090); Regression, Logistic NCT02704403 ↗
registry analysis (superiority test); 120 mg Elafibranor vs Placebo; Cox Proportional Hazard 0.950 (95% CI 0.619 to 1.457) NCT02704403 ↗
release “RESOLVE-IT Phase 3 trial, which did not meet the predefined primary surrogate efficacy endpoint” genfit.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elafibranor | Small molecule | 120 mg | Oral |