A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NCT06215716Phase 3Recruiting
- Lead sponsor
- Akero Therapeutics, Inc (Industry)
- Enrollment
- 1,650 (estimated)
- Start date
- 1 Dec 2023
- Primary completion
- Feb 2033 (estimated)
- Study completion
- 1 Feb 2033
- Last update posted
- 15 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 3
Interventions
- Efruxifermin Drug
- Placebo Drug
Conditions and primary outcome
- NASH With Fibrosis
- MASH With Fibrosis
Primary outcome
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis (52 Weeks); Event-free survival (240 Weeks)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06215716.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06215716 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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