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NCT06215716 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
A Phase 3 study of MASH With Fibrosis and NASH With Fibrosis, sponsored by Akero Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,650
- Enrollment target
- 20
- Study locations
NCT06215716: Recruiting Phase 3 study of MASH With Fibrosis and NASH With Fibrosis, sponsored by Akero Therapeutics.
NCT06215716 is a Phase 3 study of MASH With Fibrosis and NASH With Fibrosis that is actively recruiting participants, run by Akero Therapeutics. The registered enrollment target is 1,650 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (114% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06215716, a Phase 3 study of MASH With Fibrosis and NASH With Fibrosis, is actively recruiting participants, sponsored by Akero Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,650 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 non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Primary Outcome
Based on NAS (scored by 0-3 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
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 - Mesa
- Akero Clinical Study Site - Peoria
- 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 - Chula Vista
- Akero Clinical Study Site - Coronado
- Akero Clinical Study Site - Escondido
- Akero Clinical Study Site - Folsom
- Akero Clinical Study Site - Inglewood
- Akero Clinical Study Site - La Mesa
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 | 1,650 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2032-11 |
| Phase | Phase 3 |
What NCT06215716 shows while recruiting
NCT06215716 is an interventional study that assigns participants to a tested intervention. Its 1,650 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (114% higher).
The record links to 2 conditions, with MASH With Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06215716 names 20 study sites across 4 states, led by Arizona, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06215716 about?
NCT06215716 is a clinical study titled "A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis". This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
What is the current status of trial NCT06215716?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,650 participants. The study started on 2023-12-01. Estimated completion is 2032-11.
What conditions does trial NCT06215716 study?
This clinical trial studies the following conditions: MASH With Fibrosis, NASH With Fibrosis.
What interventions are being tested in trial NCT06215716?
The interventions under investigation include: Placebo (DRUG), Efruxifermin (DRUG).
Who is sponsoring clinical trial NCT06215716?
This trial is sponsored by Akero Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06215716 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06215716's enrollment target sits among peer trials
1,650 139th of 2000 higher than 1,862 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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