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NCT03976401 · ClinicalTrials.gov registry record · Phase 2
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Akero Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT03976401: Completed Phase 2 study, sponsored by Akero Therapeutics.
NCT03976401 is a Phase 2 study that has completed, run by Akero Therapeutics. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03976401, a Phase 2 study, has completed, sponsored by Akero Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.
Primary Outcome
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Interventions
- DRUG Placebo
- DRUG EFX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2022-01-10 |
| Phase | Phase 2 |
What the finished NCT03976401 record still lists
NCT03976401 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03976401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03976401 about?
NCT03976401 is a clinical study titled "A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)". This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.
What is the current status of trial NCT03976401?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2019-05-28. Estimated completion is 2022-01-10.
What interventions are being tested in trial NCT03976401?
The interventions under investigation include: Placebo (DRUG), EFX (DRUG).
Who is sponsoring clinical trial NCT03976401?
This trial is sponsored by Akero Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03976401's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 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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