Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06528314 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT06528314 · ClinicalTrials.gov record · last posted 2026-08-19

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

StatusRecruiting
PhasePhase 3
Started2024-09-04
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-08-20
Trial sites expanded: 323 → 329 locations
2026-05-19
Trial sites expanded: 318 → 321 locations
2026-04-25
Primary endpoint(s) modified
WasCohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis, Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events
NowCohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis, Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.
2026-04-25
Enrollment increased: 1150 → 2150 participants
2026-04-25
Primary completion pushed: 2029-09 → 2030-02
2026-04-25
Completion pushed: 2029-10 → 2030-03
Trial Details
NCT Number NCT06528314
Lead Sponsor Akero Therapeutics, Inc
Conditions NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Enrollment 2,150 participants
Start Date 2024-09-04
Primary Completion 2030-02 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-19