N Engl J Med

Semaglutide improves outcomes health in patients with MASH

May 6, 2025

Once-weekly semaglutide at a dose of 2.4 mg demonstrated significant efficacy in resolving steatohepatitis and reducing liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH), alongside beneficial effects on weight and glycemic control.

Study details: The phase 3, multicenter, randomized, double-blind, placebo-controlled ESSENCE trial (NCT04822181) evaluated the efficacy of semaglutide in patients with biopsy-confirmed MASH and fibrosis stage 2 or 3. A total of 1,197 patients were randomized in a 2:1 ratio to receive once-weekly SC semaglutide (2.4 mg) or placebo for 240 weeks. The interim analysis at week 72 included 800 patients.

Results: The primary endpoint of resolution of steatohepatitis without worsening of fibrosis was achieved in 62.9% of patients in the semaglutide group compared with 34.3% in the placebo group (estimated difference, 28.7 percentage points; 95% confidence interval [CI] 21.1 - 36.2; P<0.001). Additionally, 36.8% of patients in the semaglutide group showed a reduction in liver fibrosis without worsening of steatohepatitis, compared with 22.4% in the placebo group (estimated difference, 14.4 percentage points; 95% CI, 7.5 - 21.3; P<0.001). Secondary outcomes included significant weight loss and improved glycemic control in the semaglutide group. GI adverse events were more common with semaglutide.

Source:

Sanyal AJ, et al; ESSENCE Study Group. (2025, April 30). N Engl J Med. Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. https://pubmed.ncbi.nlm.nih.gov/40305708/