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RECRUITING
NCT07221227
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2025-10-23

Completion Date

2031-12-12

Last Updated

2025-10-31

Healthy Volunteers

No

Interventions

DRUG

Efimosfermin alfa

Efimosfermin alfa will be administered

DRUG

Efimosfermin alfa

Efimosfermin alfa will be administered

DRUG

Placebo

Placebo will be administered

Locations (1)

GSK Investigational Site

Miami, Florida, United States