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

> **NCT02704403** · PHASE3 · TERMINATED · sponsor: **Genfit** · enrollment: 2157 (actual)

## Conditions studied

- Nonalcoholic Steatohepatitis (NASH) With Fibrosis

## Interventions

- **DRUG:** Elafibranor
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02704403
- **Lead sponsor:** Genfit
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2016-03
- **Primary completion:** 2020-10-28
- **Final completion:** 2020-10-28
- **Target enrollment:** 2157 (ACTUAL)
- **Why stopped:** Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified
- **Last updated:** 2022-03-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02704403

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02704403, "Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT02704403. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*