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Merck Announces Positive Results from Phase 2b Trial of Efinopegdutide in Adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Stage 2-3 Fibrosis

MRK
  • Merck announced positive Phase 2b results for efinopegdutide (MK-6024), an investigational once-weekly GLP-1/glucagon receptor co-agonist, for treating adults with MASH & stage F2 or F3 liver fibrosis.
  • The trial met its primary endpoint, showing a statistically significant greater proportion of participants achieved MASH resolution without worsening of fibrosis versus placebo at 52 weeks.
  • MASH resolution rates at 52 weeks were 56% (4 mg), 63% (7 mg), & 61% (10 mg) for efinopegdutide doses compared to 13% for placebo (p<0.0001 for all doses).
  • Meaningful improvements in liver fibrosis (at least one stage) without worsening of steatohepatitis were observed in 43% (4 mg), 52% (7 mg), & 34% (10 mg) of participants versus 21% for placebo.
  • The safety profile was generally consistent with semaglutide, though nausea rates were higher for efinopegdutide (29%-44%) compared to placebo (11%).
  • Discontinuation rates due to adverse events were 3%, 4%, & 11% for the 4 mg, 7 mg, & 10 mg efinopegdutide groups respectively, compared to 1% for both placebo & semaglutide.
  • The study enrolled 386 adults, with 381 randomized & 92% completing the 52-week treatment period.
  • Efinopegdutide has received Fast Track designation from the FDA & is being developed under an exclusive licensing agreement between Merck & Hanmi Pharmaceutical.
  • Results were presented at The Liver Meeting in Denver & simultaneously published in The Lancet.