On 1 November 2024, Novo Nordisk announced positive results from part 1 of a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.
The trial (ESSENCE) is reported to have shown significant improvement in liver fibrosis and resolution of steatohepatitis without worsening liver conditions in the semaglutide group compared to placebo. After 72 weeks, 37% of semaglutide-treated participants saw improvement in liver fibrosis with no worsening of steatohepatitis, while 62.9% achieved resolution of steatohepatitis with no worsening of fibrosis, demonstrating the efficacy and tolerability of semaglutide.
The ESSENCE trial is a two-part, 240-week study designed to assess the long-term impact of semaglutide on liver health and clinical outcomes in MASH patients. Novo Nordisk plans to seek regulatory approvals based on the trial results in the US and EU by mid-2025. Final results from part 2 of the trial are expected in 2029.
This news follows Novo Nordisk’s announcement in October 2024 of positive results from its semaglutide cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide) on major adverse cardiovascular events (MACE) in individuals with type 2 diabetes and established cardiovascular disease (CVD) or chronic kidney disease (CKD).