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NCT04378010 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH
A Phase 2 study, sponsored by Enanta Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT04378010: Clinical Trial Phase 2 study, sponsored by Enanta Pharmaceuticals.
NCT04378010 is a Phase 2 study that was terminated before completion, run by Enanta Pharmaceuticals. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04378010, a Phase 2 study, was terminated before completion, sponsored by Enanta Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)
Primary Outcome
Proportion of participants who achieve ≥1 stage improvement in fibrosis without worsening of steatohepatitis and/or resolution of steatohepatitis and no worsening of liver fibrosis as determined by liver biopsy.
Interventions
- DRUG Placebo
- DRUG EDP-305 1.5 mg
- DRUG EDP-305 2 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2020-01-27 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 2 |
Why NCT04378010 stopped before completion
NCT04378010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04378010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04378010 about?
NCT04378010 is a clinical study titled "A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH". A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)
What is the current status of trial NCT04378010?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2020-01-27. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT04378010?
The interventions under investigation include: Placebo (DRUG), EDP-305 1.5 mg (DRUG), EDP-305 2 mg (DRUG).
Who is sponsoring clinical trial NCT04378010?
This trial is sponsored by Enanta Pharmaceuticals, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04378010's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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