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NCT06161571 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 3 study of NASH/MASH and NAFLD/MASLD, sponsored by Akero Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT06161571: Active Phase 3 study of NASH/MASH and NAFLD/MASLD, sponsored by Akero Therapeutics.
NCT06161571 is a Phase 3 study of NASH/MASH and NAFLD/MASLD that is active but no longer recruiting, run by Akero Therapeutics. The registered enrollment target is 700 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06161571, a Phase 3 study of NASH/MASH and NAFLD/MASLD, is active but no longer recruiting, sponsored by Akero Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Primary Outcome
A participant's extent of exposure to study drug (weeks) will be generated from the data recorded in the study drug administration eCRF.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Efruxifermin
Study Locations (20)
California
- Akero Clinical Study Site - Chula Vista
- Akero Clinical Study Site - Coronado
- Akero Clinical Study Site - Cypress
- Akero Clinical Study Site - Inglewood
- Akero Clinical Study Site - La Mesa
- Akero Clinical Study Site - Lancaster
- Akero Clinical Study Site - Los Angeles
- Akero Clinical Study Site - Los Angeles
- Akero Clinical Study Site - Palm Springs
- Akero Clinical Study Site - San Diego
Arizona
- Akero Clinical Study Site - Chandler
- Akero Clinical Study Site - Flagstaff
- Akero Clinical Study Site - Peoria
- Akero Clinical Study Site - Tucson
- Akero Clinical Study Site - Tucson
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2023-11-10 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
What the registry record for NCT06161571 still lists
NCT06161571 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 2 conditions, with NASH/MASH appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06161571 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06161571 about?
NCT06161571 is a clinical study titled "A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)". The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
What is the current status of trial NCT06161571?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2023-11-10. Estimated completion is 2026-10.
What conditions does trial NCT06161571 study?
This clinical trial studies the following conditions: NASH/MASH, NAFLD/MASLD.
What interventions are being tested in trial NCT06161571?
The interventions under investigation include: Placebo (DRUG), Efruxifermin (DRUG).
Who is sponsoring clinical trial NCT06161571?
This trial is sponsored by Akero Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06161571 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
How this trial's enrollment target compares
Where NCT06161571's enrollment target sits among peer trials
700 506th of 2000 higher than 1,485 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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