Phase 3 Clinical Study Evaluating Efimosfermin Alfa Injection Versus Placebo for Adults with Compensated Cirrhosis from Metabolic Dysfunction-associated Steatohepatitis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of efimosfermin alfa in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH. This phase 3 clinical trial aims to understand how this treatment compares to a placebo in preventing liver-related complications over a long period. Participants will receive either efimosfermin alfa or a placebo through subcutaneous injections. The study uses a randomized, parallel design with quadruple masking, meaning participants and study staff will not know who receives the active drug or placebo. The treatment period lasts up to 356 weeks, during which various liver function and fibrosis markers will be monitored. Throughout the study, participants will undergo regular assessments including liver stiffness measurements, fibrosis scores, blood tests for diabetes and cholesterol markers, and patient-reported outcomes on fatigue and liver disease impact. Safety will be closely monitored by tracking adverse events and laboratory abnormalities. The total duration of participation includes treatment and follow-up visits spanning several years.

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)