[Articles] Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study

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Source: The Lancet

Original: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02114-2/fullt...

Published: 2025-11-11T13:00:01Z

Weekly treatment with pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) achieved significant improvement at 24 weeks, with 59.1% of patients achieving resolution of MASH without worsening fibrosis in an intention-to-treat (ITT) analysis at the 1.2 mg dose, versus 19.1% in the placebo group. However, the second primary endpoint, improvement of fibrosis without deterioration of MASH, was not met statistically significantly, although improvement of fibrosis occurred in 28–36% of patients treated with pemvidutide. The treatment also produced an average weight loss of up to 6.2% over 24 weeks with no signs of weight loss stopping. The study was a multicenter, randomized, and double-blind phase 2b study, and the treatment was well tolerated with a low percentage of premature discontinuations (9%). Further studies of longer duration are planned to confirm these results and assess long-term effects. Pemvidutide received Fast Track designation from the FDA in October 2023 for the treatment of MASH.