Trial intelligence / Profile preview

ZENITH-1 efimosfermin alfa in biopsy-confirmed F2/F3 MASH

2025-523675-39-00Phase 3Authorised

Sponsor
GSK
Start
Jul 2026
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Countries
29
01

Overview

Phase 3, randomised, double-blind trial of efimosfermin in metabolic dysfunction-associated steatohepatitis (MASH) (3 arms), sponsored by GSK. Primary endpoints: Fibrosis improvement without worsening of steatohepatitis at Week 52, Resolution of steatohepatitis without worsening of fibrosis at Week 52 and 1 more. Planned start Jul 2026; status: authorised.

02

Drugs

efimosfermin
03

Conditions

metabolic dysfunction-associated steatohepatitis (MASH)

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