Semaglutide Shows Promise in Treating MASH with Liver Fibrosis in Phase III Trial

Novo Nordisk查看公司主页's semaglutide查看药品详情 2.4mg has shown positive results in the treatment of metabolic dysfunction-associated steatohepatitis (MASH (搜索)搜索该疾病) and moderate to advanced liver fibrosis (搜索)搜索该疾病. The Phase III ESSENCE trial met its primary endpoints, demonstrating a significant improvement in liver fibrosis compared to placebo.

The double-blinded, 240-week study involved 1,200 adults with MASH (搜索)搜索该疾病 and stage two or three liver fibrosis (搜索)搜索该疾病. During the first part of the trial, the effects of semaglutide查看药品详情 on liver tissue were assessed in 800 participants over 72 weeks. Semaglutide 2.4mg, a glucagon-like peptide 1 (GLP-1) receptor agonist known as Wegovy, was administered subcutaneously once weekly.

Key Findings from the ESSENCE Trial

The trial revealed that 37% of participants treated with semaglutide查看药品详情 experienced an improvement in liver fibrosis (搜索)搜索该疾病 without steatohepatitis worsening at 72 weeks, compared to 22.5% in the placebo group. Additionally, 62.9% of participants in the semaglutide group achieved resolution of steatohepatitis without any worsening of liver fibrosis, versus 34.1% in the placebo group.

The safety and tolerability profile of semaglutide查看药品详情 2.4mg was consistent with previous trials, reinforcing its potential as a viable treatment option for MASH (搜索)搜索该疾病.

Regulatory Plans and Future Outlook

Novo Nordisk查看公司主页 plans to seek regulatory approvals in the US and European Union (EU) in the first half of next year. The second part of the ESSENCE trial is ongoing, with results expected in 2029.

Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk查看公司主页, stated, "We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide查看药品详情 to help people living with MASH (搜索)搜索该疾病... Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need."

Context of MASH and Semaglutide

MASH (搜索)搜索该疾病 is a severe and progressive liver disease associated with metabolic disorders. Semaglutide查看药品详情 (Wegovy) is already approved for use alongside a reduced-calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (MACE) in adults with cardiovascular disease and obesity or those deemed overweight in the US.

Novo Nordisk查看公司主页 also plans to file for a label expansion for its oral semaglutide查看药品详情, Rybelsus, in the US and EU, following positive outcomes from the Phase III SOUL trial.