Merck reports Phase 2b trial shows 56%‑63% MASH resolution with efinopegdutide
Merck announced that its investigational GLP‑1/glucagon co‑agonist efinopegdutide met the primary efficacy endpoint in a Phase 2b study of adults with metabolic dysfunction‑associated steatohepatitis (MASH) and stage F2‑F3 fibrosis. Across three dose levels, 56%‑63% of patients achieved MASH resolution without fibrosis worsening at 52 weeks, compared with 13% on placebo. The drug also showed fibrosis improvement of 34%‑52% versus 21% for placebo and received FDA Fast Track designation.
Why it matters
The company says the data give Merck a potential entry into the emerging MASH market, which analysts estimate could exceed $1 billion in annual sales. The Fast Track designation may accelerate regulatory review if Phase 3 trials are pursued.
Key facts
- 1The MK‑6024‑013 Phase 2b trial enrolled 386 adults with biopsy‑confirmed MASH and stage F2 or F3 fibrosis. merck.com
- 2381 participants received at least one dose: efinopegdutide 4 mg (n=77), 7 mg (n=77), 10 mg (n=79), placebo (n=79) and open‑label semaglutide (n=69). merck.com
- 3MASH resolution without fibrosis worsening at 52 weeks was 56% (4 mg), 63% (7 mg) and 61% (10 mg) versus 13% for placebo. merck.com
- 4Fibrosis improvement of at least one stage was 43% (4 mg), 52% (7 mg) and 34% (10 mg) versus 21% for placebo. merck.com
- 5Discontinuations due to adverse events were 3% (4 mg), 4% (7 mg) and 11% (10 mg) versus 1% for both semaglutide and placebo. merck.com
- 6Efinopegdutide has received FDA Fast Track designation for the treatment of MASH. merck.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.