Efruxifermin in Compensated Liver Cirrhosis Caused by MASH
Abstract
In this phase 2b, randomized, placebo controlled trial, the efficacy and safety of efruxifermin, a bivalent fibroblast growth factor 21 (FGF21) analogue, were evaluated in patients with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH). The primary outcome was a reduction of at least one stage of fibrosis without worsening of MASH at week 36. Results showed no significant difference between efruxifermin and placebo at week 36, but a potential benefit was observed at week 96, particularly with the 50-mg dose. Efruxifermin also improved noninvasive markers of fibrosis and metabolic parameters. Adverse events were primarily gastrointestinal and mild to moderate in severity. The study highlights the need for longer-term trials to assess clinical outcomes in this high-risk population.