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NCT02704403 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
A Phase 3 study, sponsored by Genfit.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,157
- Enrollment target
NCT02704403: Clinical Trial Phase 3 study, sponsored by Genfit.
NCT02704403 is a Phase 3 study that was terminated before completion, run by Genfit. The registered enrollment target is 2,157 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (179% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02704403, a Phase 3 study, was terminated before completion, sponsored by Genfit.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,157 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.
Interventions
- DRUG Placebo
- DRUG Elafibranor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,157 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-10-28 |
| Phase | Phase 3 |
Why NCT02704403 stopped before completion
NCT02704403 is an interventional study that assigns participants to a tested intervention. Its 2,157 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (179% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02704403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02704403 about?
NCT02704403 is a clinical study titled "Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)". 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.
What is the current status of trial NCT02704403?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,157 participants. The study started on 2016-03. Estimated completion is 2020-10-28.
What interventions are being tested in trial NCT02704403?
The interventions under investigation include: Placebo (DRUG), Elafibranor (DRUG).
Who is sponsoring clinical trial NCT02704403?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02704403's enrollment target sits among peer trials
2,157 96th of 2000 higher than 1,905 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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