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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
2026-04-16
Healthy Volunteers
No
Conditions
Interventions
Efimosfermin Alfa
Efimosfermin Alfa will be administered
Placebo
Placebo will be administered
Locations (43)
GSK Investigational Site
Arcadia, California, United States
GSK Investigational Site
Covina, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Santa Maria, California, United States
GSK Investigational Site
Cape Coral, Florida, United States
GSK Investigational Site
Doral, Florida, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Inverness, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Kissimmee, Florida, United States
GSK Investigational Site
Lakeland, Florida, United States
GSK Investigational Site
Maitland, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Ocala, Florida, United States
GSK Investigational Site
Palmetto Bay, Florida, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Springfield, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Jersey City, New Jersey, United States
GSK Investigational Site
East Syracuse, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Morehead City, North Carolina, United States
GSK Investigational Site
Akron, Ohio, United States
GSK Investigational Site
Springboro, Ohio, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Brownsville, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
DeSoto, Texas, United States
GSK Investigational Site
Richmond, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Seabrook, Texas, United States
GSK Investigational Site
Tomball, Texas, United States
GSK Investigational Site
Waco, Texas, United States
GSK Investigational Site
Waco, Texas, United States
GSK Investigational Site
West Jordan, Utah, United States
GSK Investigational Site
Manassas, Virginia, United States
GSK Investigational Site
Seattle, Washington, United States