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Novo Nordisk's Combo Drug CagriSema Shows 16% Weight Reduction In Second Phase 3 Trial
Novo NordiskNovo Nordisk(US:NVO) Benzingaยท2025-03-11 12:35

Core Insights - Novo Nordisk A/S announced results from the REDEFINE 2 phase 3 trial, which investigated the efficacy and safety of CagriSema, a combination of cagrilintide and semaglutide, in patients with obesity or overweight and type 2 diabetes [1][6] Trial Overview - The REDEFINE 2 trial lasted 68 weeks and included 1,206 randomized participants with a mean baseline body weight of 102 kg [1] - The trial allowed for flexible dosing modifications by patients throughout the study [2] Efficacy Results - After 68 weeks, patients treated with CagriSema achieved a weight loss of 15.7%, compared to 3.1% with placebo [3] - A co-primary endpoint of weight loss of 5% or more was achieved by 89.7% of patients on CagriSema, versus 30.3% for placebo [4] - When applying the treatment policy estimand, CagriSema resulted in a weight loss of 13.7% compared to 3.4% with placebo [4] Safety Profile - CagriSema demonstrated a safe and well-tolerated profile, with the most common adverse events being mild to moderate gastrointestinal issues that diminished over time [5] Future Outlook - Novo Nordisk plans to file for the first regulatory approval of CagriSema in Q1 2026, with detailed results from both REDEFINE 1 and REDEFINE 2 expected to be presented at a scientific conference in 2025 [6] Market Reaction - Following the announcement, NVO stock increased by 0.49% to $79.35 during the premarket session [7]