FDA OKs Semaglutide 2.4 mg for Treatment of MASH Without Cirrhosis: Daily Dose

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On August 15, 2025, we reported on the US FDA approval of semaglutide 2.4 mg (Wegovy; Novo Nordisk) for the treatment of noncirrhotic metabolic dysfunction–associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (stages F2 to F3), in combination with a reduced-calorie diet and increased physical activity.

The approval

The accelerated approval for semaglutide was based on part 1 of the phase 3 ESSENCE trial, which met its primary endpoints. At week 72, 36.8% of patients receiving semaglutide achieved improvement in liver fibrosis with no worsening of steatohepatitis compared with 22.4% receiving placebo. Resolution of steatohepatitis with no worsening of liver fibrosis occurred in 62.9% of patients in the semaglutide group compared with 34.3% in the placebo group.

ESSENCE is a two-part, 240-week trial randomizing 1,200 adults with MASH and F2–F3 fibrosis to semaglutide 2.4 mg or placebo in addition to standard of care. Part 1 assessed histologic outcomes at 72 weeks; part 2 will evaluate whether semaglutide reduces the risk of liver-related clinical events, with results expected in 2029.

Wegovy was first approved in 2021 for chronic weight management in adults with obesity or overweight with weight-related comorbidities, and its indications have since expanded to include adolescents with obesity and cardiovascular risk reduction in certain adults with obesity or overweight.

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