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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
• Age \>=18 and \<=75 years at enrollment
• History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition:
• Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
Locations
United States
Florida
GSK Investigational Site
RECRUITING
Miami
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2031-12-12
Participants
Target number of participants: 1200
Treatments
Experimental: Participants receiving dose level 1 of efimosfermin alfa
Experimental: Participants receiving dose level 2 of efimosfermin alfa
Placebo_comparator: Participants receiving Placebo
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline