CagriSema (Cagrilintide + Semaglutide)

CagriSema is a fixed-dose combination of semaglutide 2.4 mg (GLP-1 agonist) with cagrilintide 2.4 mg (long-acting amylin analog), administered as a once-weekly subcutaneous co-injection. Amylin is co-secreted with insulin and reduces post-meal glucagon, slows gastric emptying, and contributes to satiety through separate neural pathways -- targeting hunger from two distinct hormonal axes for a combined effect greater than either agent alone. Novo Nordisk filed the NDA with the FDA in December 2025. FDA review ongoing as of mid-2026; decision expected late 2026 to mid-2027. The REDEFINE 1 Phase 3 trial (N=3,400, 68 weeks) demonstrated 22.7% mean total body weight loss. Adherent population: 97.6% achieved 5%+ weight loss; 60.2% achieved 20%+; 40.4% achieved 25%+; 23.1% achieved 30%+. However, REDEFINE 4 (February 2026, 84 weeks) showed CagriSema achieved 23.0% weight loss but failed non-inferiority vs tirzepatide's 25.5% -- a commercial setback. The REIMAGINE trial in T2DM (ADA 2026) showed CagriSema reduced HbA1c and weight more than semaglutide alone. Not yet commercially available. Pricing not announced. Eligibility will mirror existing GLP-1 criteria once approved: BMI 30+ or BMI 27+ with weight-related comorbidity.