Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 48-week results from a multicentre, randomised, double-blind, phase 2b study.

In biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) with F2–F3 fibrosis, weekly pemvidutide reduced liver fat by -45·2% (1·2 mg) and -54·7% (1·8 mg) at week 48 versus -8·2% with placebo.

• Why it matters: MASH with stage F2–F3 fibrosis needs effective therapies, and prior 24-week results left uncertainty about whether benefits persist and extend to key secondary liver measures by 48 weeks.
• What they did: In a 48-week multicentre, randomised, double-blind phase 2b trial (212 patients; 83 sites in the USA and Australia), patients received once-weekly subcutaneous pemvidutide 1·2 mg, 1·8 mg, or placebo without dose titration; week 48 assessed secondary endpoints using intention-to-treat analyses.
• The result: At week 48, pemvidutide also lowered corrected T1 relaxation time (difference from placebo -103·8 ms for 1·2 mg; -119·0 ms for 1·8 mg), alanine aminotransferase (difference from placebo -27·5 and -27·1 IU/L), and enhanced liver fibrosis score (difference from placebo -0·65 and -0·74), with nausea as the most frequent adverse event and no severe/serious events defined as medication related.

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