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Novo Nordisk has shared promising results from the first part of its phase 3 ESSENCE trial, studying the effects of once-weekly semaglutide 2.4 mg in adults with MASH (metabolic dysfunction-associated steatohepatitis) and moderate to advanced liver fibrosis. According to the press release, the trial met its primary goals by showing significant improvement in liver fibrosis and resolution of steatohepatitis, with no worsening of either condition compared to placebo.
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Martin Holst Lange, MD, PhD, Novo Nordisk’s EVP, expressed optimism about semaglutide’s potential to help the millions living with MASH, a serious health issue impacting about 1 in 3 people with obesity.
ESSENCE is a two-part trial with 1,200 participants, testing semaglutide 2.4 mg over 240 weeks. Part 1 focused on changes in liver histology at 72 weeks, with positive results: 37% of those on semaglutide showed improved liver fibrosis (vs. 22.5% on placebo), and 62.9% had resolution of steatohepatitis (vs. 34.1% on placebo). Semaglutide was well-tolerated, with safety consistent with previous trials.
Novo Nordisk plans to pursue regulatory approvals in the US and EU in 2025, with detailed results expected at a scientific conference in 2024.
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