Phase 3 Trial of Semaglutide in Metabolic Dysfunction–Associated Steatohepatitis

This phase 3 trial evaluated the efficacy and safety of once-weekly subcutaneous semaglutide (2.4 mg) in 800 patients with biopsy-confirmed MASH and stage 2 or 3 liver fibrosis. At 72 weeks, semaglutide significantly improved histologic outcomes compared to placebo: 62.9% of patients achieved resolution of steatohepatitis without worsening fibrosis (vs. 34.3% placebo), and 36.8% showed fibrosis reduction (vs. 22.4% placebo). Semaglutide also led to a mean weight loss of 10.5% and improved cardiometabolic markers (e.g., glycemic control, blood pressure). Gastrointestinal adverse events were more common with semaglutide, but no new safety signals emerged. These results support semaglutide as a potential treatment for MASH with moderate to advanced fibrosis.

This phase 3 trial evaluated the efficacy and safety of once-weekly subcutaneous semaglutide (2.4 mg) in 800 patients with biopsy-confirmed MASH and stage 2 or 3 liver fibrosis. At 72 weeks, semaglutide significantly improved histologic outcomes compared to placebo: 62.9% of patients achieved resolution of steatohepatitis without worsening fibrosis (vs. 34.3% placebo), and 36.8% showed fibrosis reduction (vs. 22.4% placebo). Semaglutide also led to a mean weight loss of 10.5% and improved cardiometabolic markers (e.g., glycemic control, blood pressure). Gastrointestinal adverse events were more common with semaglutide, but no new safety signals emerged. These results support semaglutide as a potential treatment for MASH with moderate to advanced fibrosis.