Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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.
What This Study Doesn't 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.
Trust & Context
- Original Title:
- Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.
- Published In:
- The New England journal of medicine, 392(21), 2089-2099 (2025)
- Authors:
- Sanyal, Arun J(3), Newsome, Philip N(4), Kliers, Iris, Østergaard, Laura Harms, Long, Michelle T, Kjær, Mette Skalshøi, Cali, Anna M G, Bugianesi, Elisabetta, Rinella, Mary E, Roden, Michael, Ratziu, Vlad
- Database ID:
- RPEP-13417
Evidence Hierarchy
Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-13417APA
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
MLA
Sanyal, Arun J, et al. "Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.." The New England journal of medicine, 2025. https://doi.org/10.1056/NEJMoa2413258
RethinkPeptides
RethinkPeptides Research Database. "Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associ..." RPEP-13417. Retrieved from https://rethinkpeptides.com/research/sanyal-2025-phase-3-trial-of
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.