Novo Nordisk(US:NVO) GLP1减重宝典·2025-07-09 08:39Core Viewpoint - Novo Nordisk's application for the 7.2 mg semaglutide for weight management has been accepted by the European Medicines Agency (EMA) based on positive results from the STEP UP trials [1][2]. Summary by Sections STEP UP Trial Overview - The STEP UP trial is a 72-week efficacy and safety study comparing the high-dose 7.2 mg semaglutide with 2.4 mg semaglutide and a placebo, involving 1,407 randomly assigned obese adults [2][4]. - The primary goal is to demonstrate that 7.2 mg semaglutide is superior to placebo in weight loss, with key secondary endpoints including the number of participants achieving weight loss of 10%, 15%, 20%, and 25% [4]. Trial Results - The trial achieved its primary endpoint, showing that patients receiving 7.2 mg semaglutide lost an average of 20.7% of their body weight after 72 weeks, compared to 17.5% for the 2.4 mg group and 2.4% for the placebo group [6]. - Among those treated with 7.2 mg semaglutide, 33.2% lost 25% or more of their body weight, while this figure was 16.7% for the 2.4 mg group and 0.0% for the placebo group [6]. - The treatment was well-tolerated, with gastrointestinal adverse events being the most common, mostly mild to moderate in severity [6]. Future Developments - Detailed results from the STEP UP trial are expected to be presented at a scientific conference in 2025 [7]. - Novo Nordisk has also initiated a second trial, STEP UP T2D, focusing on adults with type 2 diabetes and obesity, with results anticipated in the coming months [8]. Semaglutide Efficacy - The STEP series of studies indicate that semaglutide can achieve an average weight loss of 15% in obese patients, significantly outperforming previous weight loss medications that typically resulted in 5%-10% weight loss [12][16]. - In various STEP trials, semaglutide has shown consistent results in reducing body weight, improving body composition, and enhancing cardiovascular risk factors [14][15][16].