A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis

This phase 2, double blind, placebo controlled trial evaluated the efficacy and safety of subcutaneous semaglutide in 320 patients with biopsy confirmed NASH and liver fibrosis (stages F1–F3). Participants were randomized to receive once daily semaglutide (0.1 mg, 0.2 mg, or 0.4 mg) or placebo for 72 weeks. The primary endpoint was NASH resolution without worsening fibrosis, achieved in 59% of the 0.4mg group versus 17% with placebo (P<0.001). However, improvement in fibrosis stage (secondary endpoint) did not differ significantly between groups (43% vs. 33%, P=0.48). Semaglutide also induced dose dependent weight loss (mean 13% with 0.4 mg vs. 1% placebo) and reduced liver enzymes. Gastrointestinal adverse events (e.g., nausea, vomiting) were more frequent with semaglutide. The study concluded that semaglutide significantly improved NASH resolution but not fibrosis, supporting further investigation of GLP1 agonists in NASH treatment.

This phase 2, double blind, placebo controlled trial evaluated the efficacy and safety of subcutaneous semaglutide in 320 patients with biopsy confirmed NASH and liver fibrosis (stages F1–F3). Participants were randomized to receive once daily semaglutide (0.1 mg, 0.2 mg, or 0.4 mg) or placebo for 72 weeks. The primary endpoint was NASH resolution without worsening fibrosis, achieved in 59% of the 0.4mg group versus 17% with placebo (P<0.001). However, improvement in fibrosis stage (secondary endpoint) did not differ significantly between groups (43% vs. 33%, P=0.48). Semaglutide also induced dose dependent weight loss (mean 13% with 0.4 mg vs. 1% placebo) and reduced liver enzymes. Gastrointestinal adverse events (e.g., nausea, vomiting) were more frequent with semaglutide. The study concluded that semaglutide significantly improved NASH resolution but not fibrosis, supporting further investigation of GLP1 agonists in NASH treatment.