Denmark-based pharmaceutical company Novo Nordisk (NYSE: NVO; CPH: Novo-B) has announced that part 1 of the Phase III ESSENCE study, a pivotal 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, has successfully reached its primary endpoints. The trial evaluated the efficacy of once-weekly semaglutide 2.4 mg on liver tissue compared to placebo, in conjunction with standard care, for the initial 800 randomized participants over 72 weeks.
Semaglutide Demonstrates Significant Improvements in Liver Health
At the 72-week mark, 37.0% of participants treated with semaglutide 2.4 mg experienced an improvement in liver fibrosis without a worsening of steatohepatitis, compared to 22.5% on placebo. Additionally, 62.9% of those treated with semaglutide 2.4 mg achieved resolution of steatohepatitis without liver fibrosis worsening, versus 34.1% on placebo. Semaglutide 2.4 mg also showed a safe and well-tolerated profile, consistent with previous trials of the drug.
Semaglutide’s Global Reach and Upcoming Regulatory Filings
Semaglutide, an oral glucagon-like peptide-1 (GLP-1) analogue, was first approved in the US in 2017 and is now available in 52 countries/regions worldwide. In China, its injection form was approved for marketing in 2021 for the treatment of type 2 diabetes, and its oral dosage form received a green light in January this year. Novo Nordisk anticipates filing for regulatory approvals in the US and EU during the first half of 2025. Detailed results from the ESSENCE trial are scheduled to be presented at a scientific conference in 2024, with part 2 of the trial expected to report findings in 2029.- Flcube.com
