drugset / Trial / NCT02704403
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elafibranor | Small molecule | 120 mg | Oral |