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NCT04767529 · ClinicalTrials.gov registry record · Phase 2
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Akero Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT04767529: Completed Phase 2 study, sponsored by Akero Therapeutics.
NCT04767529 is a Phase 2 study that has completed, run by Akero Therapeutics. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04767529, a Phase 2 study, has completed, sponsored by Akero Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
Primary Outcome
Proportions of subjects in EFX vs placebo groups with improvement in liver fibrosis, defined as ≥ 1 stage NASH Clinical Research Network \[CRN\] fibrosis score (score ranges from 0 to 4, increasing with fibrosis severity), and no worsening of steatohepatitis (no increase in NASH Activity Score \[NAS\], which ranges from 0 to 8 and is the sum of scores of steatosis, lobular inflammation, and hepatocyte ballooning), at Week 24
Interventions
- DRUG Placebo
- DRUG Efruxifermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2024-05-02 |
| Phase | Phase 2 |
What the finished NCT04767529 record still lists
NCT04767529 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04767529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04767529 about?
NCT04767529 is a clinical study titled "A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)". This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
What is the current status of trial NCT04767529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2021-02-16. Estimated completion is 2024-05-02.
What interventions are being tested in trial NCT04767529?
The interventions under investigation include: Placebo (DRUG), Efruxifermin (DRUG).
Who is sponsoring clinical trial NCT04767529?
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 NCT04767529's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 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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