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Semaglutide Shows Potential to Transform Treatment of Advanced Fatty Liver Disease

Phase III trial results indicate the drug resolves liver inflammation in most patients with MASH and improves fibrosis, with FDA approval under priority review.

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Overview

  • The ESSENCE Phase III trial demonstrated semaglutide's efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH), resolving liver inflammation in 63% of patients and improving fibrosis in 37%.
  • Participants receiving semaglutide experienced significant weight loss, averaging 10.5% of body weight, compared to 2% in the placebo group.
  • MASH, a severe form of fatty liver disease linked to obesity and diabetes, affects 5–7% of U.S. adults and can lead to cirrhosis, liver failure, or cancer.
  • Adverse effects of semaglutide were primarily gastrointestinal, with low discontinuation rates, highlighting its tolerability in long-term use.
  • Novo Nordisk has submitted semaglutide for FDA approval to treat MASH, with a priority review decision expected by the end of 2025.