A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

NCT06528314Phase 3Recruiting

Lead sponsor
Akero Therapeutics, Inc (Industry)
Enrollment
2,150 (estimated)
Start date
4 Oct 2024
Primary completion
Feb 2030 (estimated)
Study completion
1 Mar 2030
Last update posted
13 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Efruxifermin Drug
  • Placebo Drug

Conditions and primary outcome

  • NASH - Nonalcoholic Steatohepatitis
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

Primary outcome

Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. (5 years); Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis (96 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 NCT06528314.

CT-VCA trial quality

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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