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NCT06419374 · ClinicalTrials.gov record · last posted 2026-08-05

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

StatusRecruiting
PhasePhase 3
Started2024-05-24
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Protocol amendment history 5 changes detected by DataLookout

2026-08-06
Trial sites expanded: 317 → 321 locations
2026-07-09
Trial sites expanded: 303 → 317 locations
2026-06-05
Trial sites expanded: 296 → 303 locations
2026-05-07
Trial sites expanded: 291 → 296 locations
2026-04-04
Trial sites expanded: 284 → 291 locations
Trial Details
NCT Number NCT06419374
Lead Sponsor 89bio, Inc.
Conditions Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Enrollment 762 participants
Start Date 2024-05-24
Primary Completion 2028-06 (estimated)
Study Completion 2031-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-05