This record provides bibliographic details and links to the original research. An editorial study breakdown is not available.
What the researchers found
Semaglutide 2.4 mg resolved MASH in 62.9% of patients versus 34.3% with placebo, and reduced liver fibrosis in 36.8% versus 22.4%, at the 72-week interim analysis.
Why it matters
MASH (fatty liver disease with inflammation and scarring) has no widely approved drug treatment. This landmark NEJM trial positions semaglutide as a potential first-line therapy for a disease affecting millions.
The numbers in context
n=1,197 (2:1 randomization); MASH resolution: 62.9% vs 34.3% (diff 28.7%, p<0.001); fibrosis reduction: 36.8% vs 22.4% (diff 14.4%, p<0.001); combined: 32.7% vs 16.1% (p<0.001); weight: -10.5% vs -2.0% (p<0.001)
How the study worked
Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Patients with biopsy-confirmed MASH and fibrosis stage 2-3. Weekly SC semaglutide 2.4 mg vs placebo for 240 weeks. Interim analysis at 72 weeks (first 800 patients). Primary endpoints: MASH resolution without fibrosis worsening; fibrosis improvement without MASH worsening.
Who was studied
Adults with biopsy-confirmed MASH and liver fibrosis stage 2 or 3
What this study cannot tell us
Interim analysis; full trial (240 weeks) still ongoing. GI adverse events common with semaglutide. Pain scores did not improve. Long-term durability and effect on liver-related clinical events unknown.
Read the original research
Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.
The New England journal of medicine, 392(21), 2089-2099
Citation
Sanyal, Arun J; Newsome, Philip N; Kliers, Iris; Østergaard, Laura Harms; Long, Michelle T; Kjær, Mette Skalshøi; Cali, Anna M G; Bugianesi, Elisabetta; Rinella, Mary E; Roden, Michael; Ratziu, Vlad. (2025). Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.. The New England journal of medicine, 392(21), 2089-2099. https://doi.org/10.1056/NEJMoa2413258