Efficacy and safety of efinopegdutide in adults with metabolic dysfunction-associated steatohepatitis and stage 2-3 fibrosis: a phase 2b, randomised, placebo-controlled study.

Efinopegdutide in adults with biopsy-confirmed non-cirrhotic MASH and stage 2–3 fibrosis achieved MASH resolution without worsening fibrosis in 56%–63% versus 13% with placebo at week 52.

• Why it matters: MASH with stage 2–3 fibrosis needs effective, safe therapies that improve histology, but prior options have limited evidence for achieving both resolution and non-worsening fibrosis.
• What they did: In a phase 2b, randomised, placebo-controlled, double-blind trial across 176 centres in 26 countries, adults received weekly subcutaneous efinopegdutide (4 mg, 7 mg, or 10 mg) or placebo, with semaglutide 2·4 mg open-label; the primary endpoint was assessed at week 52.
• The result: At week 52, MASH resolution without fibrosis worsening occurred in 31/55 (4 mg), 31/49 (7 mg), and 35/57 (10 mg) versus 7/53 on placebo; fibrosis improvement by ≥1 stage without steatohepatitis worsening occurred in 43%–52% on efinopegdutide versus 21% on placebo, with gastrointestinal adverse events highest at 10 mg.

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