Phase 2 Study of Efimosfermin Alfa Treatment in Adults With Biopsy-Confirmed Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis

What this Trial Is About

Researchers are evaluating the safety, tolerability, preliminary effectiveness, and how the body processes efimosfermin in adults with metabolic dysfunction-associated steatohepatitis MASH and compensated cirrhosis showing stage F4 fibrosis. This study focuses on people diagnosed by liver biopsy with advanced but stable liver disease caused by metabolic problems. It aims to understand the impact of efimosfermin on this condition. Participants will be randomly assigned to one of three groups two groups will receive different doses of efimosfermin, and one group will receive a placebo. All treatments are given as subcutaneous injections once every four weeks. The study will last up to 100 weeks for safety and includes monitoring drug levels in the blood up to 21 weeks. The comparison of two doses of efimosfermin versus placebo allows researchers to assess tolerability and drug behavior. During the trial, participants will be regularly assessed for any treatment-related side effects and have blood samples taken to measure drug concentrations. Researchers will monitor adverse events from the first day through 100 weeks. The study includes multiple visits for injections and evaluations. Participants will be observed closely to gather information on safety and the drugs effects over time, with the total duration extending up to nearly two years.

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