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Cagrilintide

Grade B: Human evidence, not approved for this use

TL;DR: Cagrilintide is an investigational once-weekly long-acting amylin analog developed by Novo Nordisk, studied primarily as a component of the combination product CagriSema and as a monotherapy. Phase 2 dose-finding RCT data established dose-dependent weight loss, with nausea rates of approximately 20-47% across the dose range. In the Phase 3 REDEFINE 1 trial (68 weeks), cagrilintide 2.4 mg monotherapy produced approximately 11.8% mean body weight reduction, with approximately 31.6% of participants achieving at least 15% weight loss versus 4.7% with placebo. Novo Nordisk has announced advancement of cagrilintide into a dedicated clinical programme following REDEFINE data. The compound is not independently FDA-approved; evidence is Grade B.

Key Takeaways

  • Grade B: Human evidence, not approved for this use
  • Not FDA approved: Investigational; advancing in dedicated clinical programme; NDA not submitted as of June 2026.
  • Compounding: Not approved by FDA as of June 2026. Cagrilintide is not listed for compounding under 503A or 503B; it is not eligible for compounding as an unapproved investigational substance.
Cagrilintide chemical structure
Structure via PubChem CID 171397054

Mechanism

Long-acting analogue of amylin (a hormone co-secreted with insulin) that activates amylin receptors 1 and 3 in the brain to suppress appetite and slow gastric emptying.

Evidence

Cagrilintide is an investigational once-weekly long-acting amylin analog developed by Novo Nordisk, studied primarily as a component of the combination product CagriSema and as a monotherapy. Phase 2 dose-finding RCT data established dose-dependent weight loss, with nausea rates of approximately 20-47% across the dose range. In the Phase 3 REDEFINE 1 trial (68 weeks), cagrilintide 2.4 mg monotherapy produced approximately 11.8% mean body weight reduction, with approximately 31.6% of participants achieving at least 15% weight loss versus 4.7% with placebo. Novo Nordisk has announced advancement of cagrilintide into a dedicated clinical programme following REDEFINE data. The compound is not independently FDA-approved; evidence is Grade B.

Safety and risks

Gastrointestinal adverse events are the primary safety signal, consistent with the compound's mechanism of slowing gastric emptying: nausea rates of 20-47% were observed across Phase 2 doses in a dose-dependent manner. In REDEFINE 1 Phase 3 data, approximately 1.0% of cagrilintide-treated participants discontinued due to nausea versus 0.1% on placebo. Vomiting and constipation were also reported across studies. Cagrilintide does not carry the thyroid C-cell tumor class warning applicable to GLP-1 receptor agonists, as it acts on amylin receptors rather than GLP-1 receptors; however, when co-administered with semaglutide as CagriSema, the GLP-1 class risk applies to the semaglutide component. No unique safety signals attributable specifically to the amylin mechanism were identified in published Phase 3 data. Cagrilintide notably does not produce clinically relevant QTc prolongation as confirmed in a dedicated thorough QT study. The full monotherapy risk profile remains to be established in regulatory review.

Interactions

No approved label; may potentiate glycemic effects when co-administered with antidiabetic agents. When combined with semaglutide as CagriSema, all GLP-1 receptor agonist class interactions apply. Confirm at prescribing.

Compounding legality

Not approved by FDA as of June 2026. Cagrilintide is not listed for compounding under 503A or 503B; it is not eligible for compounding as an unapproved investigational substance.

Sources

  1. Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity. (2024) other
  2. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. (2025) rct
  3. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. (2025) rct
  4. 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. (2021) rct
  5. Development of Cagrilintide, a Long-Acting Amylin Analogue. (2021) other
  6. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3. (2025) other
  7. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. (2025) other
  8. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2ยท4 mg for weight management: a randomised, controlled, phase 1b trial. (2021) rct
  9. Characterization of 0839 - A tool compound for pre-clinical mode-of-action studies of amylin analogues such as cagrilintide. (2025) other
  10. Cagrilintide plus semaglutide for obesity management. (2021) other
  11. Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors. (2026) other
  12. Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. (2024) rct
  13. A Cross-Species Atlas of the Dorsal Vagal Complex Reveals Neural Mediators of Cagrilintide's Effects on Energy Balance. (2025) other
  14. Does receptor balance matter? - Comparing the efficacies of the dual amylin and calcitonin receptor agonists cagrilintide and KBP-336 on metabolic parameters in preclinical models. (2022) other
  15. Cagrilintide and CagriSema for weight reduction and metabolic risk modification in overweight or obesity: a systematic review and meta-analysis. (2026) review

Cagrilintide is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).