CagriSema, a fixed-dose combination of cagrilintide 2.4 mg (an amylin analogue) and semaglutide 2.4 mg, achieved 22.7% average weight loss in the REDEFINE 1 Phase 3 trial — exceeding #2 Wegovy's 14.9% by adding amylin receptor activation for synergistic appetite suppression. Among completers, 91.9% lost at least 5% of body weight versus 31.5% with placebo, with one-third losing 25% or more. An NDA was submitted to the FDA on December 18, 2025, positioning it as the most advanced next-generation obesity therapy. Approval is expected by late 2026 or early 2027; no list price or commercial brand is yet available.
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