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A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
Sponsor: GlaxoSmithKline
Summary
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1250
Start Date
2025-12-12
Completion Date
2028-03-24
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Efimosfermin Alfa
Efimosfermin Alfa will be administered
Placebo
Placebo will be administered
Locations (6)
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Ocala, Florida, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Waco, Texas, United States