Cagrilintide
Phase 3 (REDEFINE program); Novo Nordisk filed an NDA for the combination product CagriSema (cagrilintide + semaglutide) in December 2025, FDA decision anticipated late 2026.
Cagrilintide is a long-acting synthetic amylin analogue that agonizes amylin (AMY1R/AMY3R) and calcitonin receptors, slowing gastric emptying and increasing satiety via hindbrain signaling. It is stud...
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Mechanism of Action
Cagrilintide is a long-acting synthetic amylin analogue that agonizes amylin (AMY1R/AMY3R) and calcitonin receptors, slowing gastric emptying and increasing satiety via hindbrain signaling. It is studied both alone and, more prominently, in combination with semaglutide, where it synergizes via complementary appetite pathways. In the Phase 3 REDEFINE 1 trial, the combination produced 20.4% mean weight reduction at 68 weeks versus 3.0% for placebo; gastrointestinal adverse events (nausea, vomiting, constipation) were the dominant safety finding, occurring in roughly 80% of combination-treated participants versus 40% on placebo, mostly mild-to-moderate.