Novo Nordisk's Weight Loss Injection CagriSema Data Sparks Investor Concern

Core Insights - The New England Journal of Medicine published results from Novo Nordisk's phase 3 REDEFINE 1 trial of CagriSema, showing significant weight loss in adults with obesity or overweight and weight-related medical complications [1][3]. CagriSema Overview - CagriSema is a once-weekly subcutaneous injectable treatment combining GLP-1 RA semaglutide and amylin analog cagrilintide, being investigated for weight management and type 2 diabetes [2]. REDEFINE 1 Trial Results - In the REDEFINE 1 trial, patients adhering to treatment with CagriSema experienced a weight loss of 22.7% at 68 weeks compared to 2.3% in the placebo group [3]. - Regardless of adherence, CagriSema users achieved a statistically significant weight loss of 20.4% versus 3.0% for the placebo group [3]. - 50.7% of participants treated with CagriSema reached a BMI of less than 30 kg/m², compared to 10.2% in the placebo group [4]. - 40.4% of those adhering to treatment achieved a weight reduction of ≥25%, and 23.1% lost ≥30% of their body weight [5]. REDEFINE 2 Study Insights - The REDEFINE 2 study showed a mean body weight change of -15.7% with CagriSema versus -3.1% with placebo for adherent participants [7]. - A higher percentage of participants on CagriSema lost significant weight compared to placebo: >5% (83.6% vs. 30.8%), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%) [8]. Safety Profile - Adverse events in the REDEFINE 1 trial were primarily gastrointestinal, with 79.6% in the CagriSema group versus 39.9% in the placebo group [12]. - Common adverse events included nausea (55% vs. 12.6%), constipation (30.7% vs. 11.6%), and vomiting (26.1% vs. 4.1%) [12]. Market Reaction - Following the trial results, Novo Nordisk's stock (NVO) declined over 7% in premarket trading, indicating market concerns regarding the side effect profile of CagriSema compared to competitors [10][13].