Novo Nordisk(US:NVO) GLP1减重宝典·2025-12-15 10:43Core Viewpoint - Novo Nordisk has submitted a supplemental new drug application (sNDA) to the FDA for a higher dose of semaglutide injection (7.2 mg) aimed at long-term weight management in adults with obesity, which is part of a fast-track approval process [3][4]. Group 1: Clinical Trial Results - The sNDA includes results from the STEP UP trial, a 72-week randomized, double-blind, placebo-controlled study involving 1,407 adults with obesity (BMI ≥ 30 kg/m²) [4]. - Patients receiving 7.2 mg of semaglutide lost an average of 20.7% of their body weight after 72 weeks, compared to 17.5% for those on 2.4 mg and 2.4% for the placebo group [4]. - Among patients who adhered to the treatment, 33.2% in the 7.2 mg group achieved a weight loss of 25% or more, compared to 16.7% in the 2.4 mg group and 0.0% in the placebo group [4]. Group 2: Weight Loss Metrics - In the 7.2 mg group, 90.7% of participants lost at least 5% of their body weight, while the figures were 89.9% for the 2.4 mg group and 36.8% for the placebo group [5]. - After 72 weeks, 31.2% of those on 7.2 mg achieved a weight loss of 25% or more, compared to 15.3% in the 2.4 mg group and 0.0% in the placebo group [5]. Group 3: Safety and Regulatory Status - The 7.2 mg group reported a higher incidence of gastrointestinal adverse events compared to the 2.4 mg and placebo groups, with serious adverse events reported at rates of 6.8%, 10.9%, and 5.5%, respectively [5]. - The European Medicines Agency (EMA) and other regulatory bodies are currently reviewing the new high-dose semaglutide, with a decision expected in Q1 2026 [5].