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...
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.
New England Journal of Medicine · 2025
Phase 3 REDEFINE 1 trial found 20.4% mean weight reduction at week 68 versus 3.0% for placebo.
View Source →The Lancet · 2021
Phase 2 dose-finding trial found dose-dependent weight loss of 6.0-10.8% versus 3.0% for placebo, with the top dose beating liraglutide 3.0 mg.
View Source →The Lancet · 2021
Phase 1b trial found the cagrilintide/semaglutide combination produced 15.4-17.1% weight loss versus 8.0-9.8% for comparators, well tolerated.
View Source →Journal of Medicinal Chemistry · 2021
Describes the engineered, fibrillation-resistant amylin analogue design underlying cagrilintide.
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