Phase 3 Trial Evaluating Efimosfermin Alfa Injection Compared to Placebo in 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 aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH. This Phase 3, multi-center, randomized study includes two parts Part A compares efimosfermin alfa with a placebo, while Part B is an open-label phase for participants who complete Part A and meet inclusion criteria. The study is sponsored by GlaxoSmithKline. In Part A, participants will be randomly assigned to receive either efimosfermin alfa or a placebo, both given as subcutaneous injections. Those who finish Part A and qualify can join Part B, where all participants receive efimosfermin alfa. The treatment period in Part A lasts up to 96 weeks, with ongoing monitoring of liver health and safety throughout. Participants will undergo various assessments including liver biopsies, vibration-controlled transient elastography to measure liver stiffness, and enhanced liver fibrosis scoring at baseline and Week 96. Researchers will also monitor treatment-emergent adverse events and laboratory results to evaluate safety. The main outcome is improvement in liver fibrosis by at least one stage without worsening of MASH at Week 96. The total study duration extends through 2033, allowing for long-term observation and follow-up.

A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)