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NCT06528314 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
A Phase 3 study of NASH - Nonalcoholic Steatohepatitis and MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Akero Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,150
- Enrollment target
- 20
- Study locations
NCT06528314: Recruiting Phase 3 study of NASH - Nonalcoholic Steatohepatitis and MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Akero Therapeutics.
NCT06528314 is a Phase 3 study of NASH - Nonalcoholic Steatohepatitis and MASH - Metabolic Dysfunction-Associated Steatohepatitis that is actively recruiting participants, run by Akero Therapeutics. The registered enrollment target is 1,150 participants, above the 221-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (420% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06528314, a Phase 3 study of NASH - Nonalcoholic Steatohepatitis and MASH - Metabolic Dysfunction-Associated Steatohepatitis, is actively recruiting participants, sponsored by Akero Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,150 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Primary Outcome
Measured by composite of protocol-specified clinical events
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Efruxifermin
Study Locations (20)
Arizona
- Akero Clinical Study Site - Chandler
- Akero Clinical Study Site - Flagstaff
- Akero Clinical Study Site - Peoria
- Akero Clinical Study Site - Scottsdale
- Akero Clinical Study Site - Tucson
- Akero Clinical Study Site - Tucson
- Akero Clinical Study Site - Tucson
- Akero Clinical Study Site - Tucson
California
- Akero Clinical Study Site - Coronado
- Akero Clinical Study Site - Escondido
- Akero Clinical Study Site - Folsom
- Akero Clinical Study Site - Lancaster
- Akero Clinical Study Site - Long Beach
- Akero Clinical Study Site - Los Angeles
Arkansas
- Akero Clinical Study Site - Conway
- Akero Clinical Study Site - Jonesboro
- Akero Clinical Study Site - Little Rock
- Akero Clinical Study Site - North Little Rock
Alabama
- Akero Clinical Study Site - Birmingham
- Akero Clinical Study Site - Dothan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,150 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2029-10 |
| Phase | Phase 3 |
What NCT06528314 shows while recruiting
NCT06528314 is an interventional study that assigns participants to a tested intervention. Its 1,150 participants enrollment target places it among the larger protocols in the corpus, above the 221-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (420% higher).
The record links to 2 conditions, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06528314 names 20 study sites across 4 states, led by Arizona, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06528314 about?
NCT06528314 is a clinical study titled "A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH". This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
What is the current status of trial NCT06528314?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,150 participants. The study started on 2024-09-04. Estimated completion is 2029-10.
What conditions does trial NCT06528314 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis.
What interventions are being tested in trial NCT06528314?
The interventions under investigation include: Placebo (DRUG), Efruxifermin (DRUG).
Who is sponsoring clinical trial NCT06528314?
This trial is sponsored by Akero Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06528314 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06528314's enrollment target sits among peer trials
1,150 2nd of 28 the highest of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis 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.
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