Novo Nordisk has revealed encouraging outcomes from a late-stage study of
semaglutide in patients suffering from
metabolic dysfunction-associated steatohepatitis (MASH), a
chronic liver disease. The ongoing ESSENCE trial focuses on the effects of the
GLP-1 receptor agonist in adults with MASH and
moderate to severe liver fibrosis.
The initial results from the study indicated that 37% of patients receiving a weekly dose of 2.4mg semaglutide showed an improvement in liver fibrosis without a deterioration in steatohepatitis over a period of 72 weeks. In contrast, only 22.5% of patients given a placebo experienced similar improvements. Furthermore, 62.9% of those treated with semaglutide achieved resolution of steatohepatitis without any worsening of liver fibrosis, compared to 34.1% in the placebo group.
MASH, also referred to as nonalcoholic steatohepatitis, is a condition caused by an excessive accumulation of fat in the liver, which can lead to severe liver diseases, including liver cancer. This disease is strongly associated with obesity and conditions like type 2 diabetes, affecting more than one-third of individuals who are overweight or obese.
Semaglutide is already marketed under brand names such as Ozempic and Wegovy and is approved for various uses, including diabetes management, weight control, and reducing cardiovascular risks. Novo Nordisk is planning to seek regulatory approvals for semaglutide in the treatment of MASH in the United States and the European Union in the first half of 2025.
Martin Holst Lange, executive vice president and head of development at Novo Nordisk, expressed satisfaction with the ESSENCE trial results, highlighting the potential of semaglutide to benefit individuals with MASH. He emphasized the significant impact of the disease on people who are overweight or obese, noting the substantial unmet medical need.
These findings follow Novo Nordisk's recent announcement of entering into a substantial partnership with NanoVation Therapeutics. This multi-year collaboration, valued at $600 million, aims to advance genetic treatments for cardiometabolic and rare diseases. The partnership brings together Novo Nordisk's expertise in these medical areas with NanoVation's innovative lipid nanoparticle technology for RNA delivery to cells outside the liver.
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