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A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Sponsor: GlaxoSmithKline
Summary
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Official title: A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1740
Start Date
2026-07-22
Completion Date
2033-08-24
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
Efimosfermin alfa
Efimosfermin alfa (subcutaneous injection) will be administered.
Placebo
Placebo (subcutaneous injection) will be administered.
Locations (15)
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Folsom, California, United States
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
Arlington, Texas, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Bellaire, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Humble, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Ōgaki, Gifu, Japan
GSK Investigational Site
Kawasaki-shi, Japan