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A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * Ability to understand and sign a written informed consent form (ICF) * Age 18 through 75 years at enrollment * History or presence of 2 or more of the 5 components of metabolic syndrome * Liver biopsy confirmation of MASH consistent with stage F4 fibrosis * Other inclusion criteria may apply. Exclusion Criteria: * Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease * History of type 1 diabetes * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN) * Other exclusion criteria may apply.
About the study
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
What is being tested
- Efimosfermin (drug)
- Placebo (drug)
Sponsor: GlaxoSmithKline · Participants: 42 · Started: Apr 9, 2025
Contact the study team
- US GSK Clinical Trials Call Center · Phone: 877-379-3718
- EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466
Official record on ClinicalTrials.gov — NCT06920043
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.