A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

Conditions: Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 42

Sponsor: GlaxoSmithKline

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06920043). StuddyBuddy aggregates publicly available trial information.