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A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Sponsor: GlaxoSmithKline
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
Conditions
Interventions
Efimosfermin alfa
Efimosfermin alfa will be administered
Efimosfermin alfa
Efimosfermin alfa will be administered
Placebo
Placebo will be administered
Locations (1)
GSK Investigational Site
Miami, Florida, United States