Peptide Profile
Cagrilintide
Long-Acting Amylin Analog / Dual Amylin and Calcitonin Receptor Agonist (DACRA)
CLINICAL DEVELOPMENT STAGE:
Phase 3
Cagrilintide is an investigational long-acting amylin analog that activates amylin and calcitonin receptors. It is currently in Phase 3 clinical development, with research focused primarily on satiety, metabolic regulation, and body-weight regulation.
Compound Overview
Molecular Formula
C₁₉₄H₃₁₂N₅₄O₅₉S₂
Molecular Weight
4,409 g/mol
CAS Number
1415456-99-3
Classification
Long-Acting Amylin Analog / Dual Amylin and Calcitonin Receptor Agonist (DACRA)
Regulatory Status
Investigational; not FDA approved.
Targets / Receptors
Amylin receptor signaling; calcitonin receptor activation; satiety regulation; appetite control; gastric emptying; energy intake; body-weight regulation; glucose metabolism
Research Focus
Amylin receptor signaling; satiety regulation; body-weight regulation; energy intake; glucose metabolism; gastric emptying; metabolic signaling
Mechanism of Action
Cagrilintide is a long-acting amylin analog that activates amylin and calcitonin-family receptors. Amylin receptor signaling is involved in satiety, food-intake regulation, gastric emptying, and glucose-related metabolic signaling.
Amylin receptors are complexes formed from the calcitonin receptor and receptor activity-modifying proteins. Structural research published in 2025 demonstrated cagrilintide binding and activation at AMY1, AMY2, AMY3 and calcitonin receptors, supporting its classification as a dual amylin/calcitonin receptor agonist.
Research Evidence
Cagrilintide has progressed from early clinical studies into Phase 3 development. In a randomized Phase 2 study involving 706 participants assigned to cagrilintide, multiple cagrilintide groups produced greater mean body-weight reductions than placebo over 26 weeks. The highest studied group in that trial showed a 10.8% mean reduction compared with 3.0% with placebo under the trial-product estimand.
Cagrilintide was subsequently evaluated as a monotherapy arm within the Phase 3 REDEFINE 1 program. A 2025 analysis reported a mean body-weight reduction of 11.8% versus 2.3% with placebo after 68 weeks under the estimand assuming treatment adherence. These findings led Novo Nordisk to advance standalone cagrilintide into the dedicated RENEW Phase 3 program.
Cagrilintide is also being studied in combination with the GLP-1 receptor agonist semaglutide as CagriSema. Results involving CagriSema should be distinguished from cagrilintide monotherapy because the combination activates two separate hormonal signaling pathways.
Safety & Limitations
Cagrilintide remains investigational, so its full long-term safety profile and benefit-risk profile have not yet been established through regulatory approval.
In the Phase 2 study, the most frequently reported adverse events were gastrointestinal, particularly nausea, constipation, and diarrhea, along with administration-site reactions.
Phase 3 cagrilintide data have also reported gastrointestinal adverse events including nausea, vomiting, diarrhea, and constipation, generally described in the trial population as primarily transient and mild to moderate. However, ongoing Phase 3 studies are specifically intended to provide additional evidence regarding efficacy and safety.
Evidence from CagriSema should not automatically be attributed to cagrilintide alone, since semaglutide contributes GLP-1 receptor activity that cagrilintide itself does not possess.
Key References
- Lau DCW, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. The Lancet. 2021.
- Garvey WT, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. 2025.
- Cao J, et al. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. Nature Communications. 2025.
- Gu Y-M, et al. Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors. Acta Pharmacologica Sinica. 2026.
Last scientifically reviewed: August 27, 2026
