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A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Study acronym: ZENITH-1
StatusRecruiting
PhasePhase 3
Started2025-10-24
View on ClinicalTrials.gov ↗
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Amendment history 1 change detected by DataLookout

2026-07-28
minor
Trial sites expanded: 49 → 91 locations
Trial Details
NCT Number NCT07221227
Lead Sponsor GlaxoSmithKline
Conditions Non-alcoholic Fatty Liver Disease
Enrollment 1,200 participants
Start Date 2025-10-24
Primary Completion 2028-03-29 (estimated)
Study Completion 2031-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-27