NCT07701993PHASE3Recruiting
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)
GlaxoSmithKline
Start Date
7/22/2026
Completion Date
8/24/2033
Summary
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Eligibility Criteria
Age Range: 18 years to 75 years
Inclusion Criteria:
* Participants aged between 18 and 75 years at enrollment.
* Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
* Participants with history or presence of at least two components of metabolic syndrome.
Exclusion Criteria:
* Participants with other chronic liver diseases.
* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
* Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.
* Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
* Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
* Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5 times upper limit normal (ULN).
* Participants with current or history of excessive alcohol intake.
Interventions
DRUG
Efimosfermin alfa
DRUG
Placebo
Conditions
Metabolic Dysfunction-associated Steatohepatitis
Locations
GSK Investigational Site
Little Rock, Arkansas 72211
United States
GSK Investigational Site
Folsom, California 95630
United States
GSK Investigational Site
Miami, Florida 33135-4661
United States
GSK Investigational Site
Miami, Florida 33155
United States
GSK Investigational Site
Ocala, Florida 34471
United States
GSK Investigational Site
St Louis, Missouri 63141
United States
GSK Investigational Site
Arlington, Texas 76012
United States
GSK Investigational Site
Austin, Texas 78745-5675
United States
GSK Investigational Site
Bellaire, Texas 77401
United States
GSK Investigational Site
Dallas, Texas 75243-1921
United States
GSK Investigational Site
Humble, Texas 77346
United States
GSK Investigational Site
San Antonio, Texas 78209
United States
GSK Investigational Site
San Antonio, Texas 78215
United States
GSK Investigational Site
Ōgaki, Gifu 503-8502
Japan
GSK Investigational Site
Kawasaki-shi, 215-0026
Japan