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)
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures 2. Age \>=18 and \<=75 years at enrollment 3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition 4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist Exclusion Criteria: 1. Contraindication or ineligibility for percutaneous liver biopsy 2. ALT or AST \>=5 x upper limit of normal (ULN) 3. T…
Interventions
- DrugEfimosfermin alfa
Efimosfermin alfa will be administered
- DrugEfimosfermin alfa
Efimosfermin alfa will be administered
- DrugPlacebo
Placebo will be administered
Locations (49)
- GSK Investigational SiteArcadia, California
- GSK Investigational SiteCovina, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteSanta Maria, California
- GSK Investigational SiteVan Nuys, California
- GSK Investigational SiteBoynton Beach, Florida