Cagriniltide: Safety Profile & Research Summary
19 PubMed CitationsExpert ReviewedGMP CertifiedLast Reviewed: February 2026
Preclinical Research Summary
Key Preclinical Studies
| Study | Model | Key Findings | Ref |
|---|---|---|---|
| Carvas et al. (2025) | 129S2/SvEv mice — WT vs RAMP1/3 KO; 3–300 nmol/kg SC | 30 nmol/kg: 24h food intake ↓51%; WT lost -3.4g (-6.6%), KO had no effect; 57% fewer AP neurons activated in KO | [8] |
| Kruse et al. (2021) | Male SD rats — 0.1–30 nmol/kg SC; PK: 10 nmol/kg IV/SC | Food intake reduced for several days at 1–10 nmol/kg; T½ 20h (IV), 27h (SC) | [3] |
| Dahl et al. (2024) | Rats — 30 nmol/kg single SC injection | Food intake reduced 85% at 0–24h and 84% at 24–48h; EC50: hAMY3R 49 pM, hCTR 62 pM | [13] |
Clinical / Human Studies
| Trial | Design | Key Results | Outcome |
|---|---|---|---|
| REDEFINE 1 NCT05567796 | Phase 3; n=3,417; 68-week RCT; CagriSema 2.4/2.4mg vs sema vs cagri vs placebo | Weight loss: 22.7% (CagriSema) vs 15–16% (sema) vs 11.8% (cagri); SBP -10.9 mmHg; GI AEs 79.6% | SUCCESS[5] |
| REDEFINE 2 NCT05394519 | Phase 3; n=1,206; 68-week RCT in T2D; CagriSema vs placebo | Weight loss: 13.7% vs 3.4%; 73.5% achieved HbA1c <6.5% vs 15.9% | SUCCESS[6] |
| REIMAGINE 2 NCT06065540 | Phase 3; n=2,728; 68-week active-controlled; CagriSema vs sema 2.4mg | HbA1c: -1.91% vs -1.76% (superiority); weight: 14.2% vs 10.2% | SUCCESS |
| Phase 2 T2D | n=92; 32-week; CagriSema vs sema vs cagri | HbA1c: -2.2% (CagriSema) vs -1.8% vs -0.9%; weight: -15.6% vs -5.1% vs -8.1% | SUCCESS[4] |
| Phase 2 Obesity | n=706; 26-week dose-finding; cagri (0.3–4.5mg) vs liraglutide vs placebo | 4.5mg: 10.8% loss; 2.4mg: 8.9%; liraglutide 3.0mg: 9.0% | SUCCESS[2] |
| Phase 1b | n=95; 20-week; cagri 2.4mg + sema 2.4mg | Weight loss: 17.1% vs 9.8% (sema alone) | SUCCESS[1] |
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References
- Enebo LB, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet, 397(10286), 1736-1748, 2021.
- 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. Lancet, 398(10317), 2160-2172, 2021.
- Kruse T, et al. Development of Cagrilintide, a Long-Acting Amylin Analogue. Journal of Medicinal Chemistry, 64(15), 11183-11194, 2021.
- Frias JP, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet, 402(10403), 720-730, 2023.
- Garvey WT, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine, 393(7), 635-647, 2025.
- Davies MJ, et al. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine, 393(7), 648-659, 2025.
- Verma S, et al. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1. Hypertension, 83(2), e26055, 2026.
- Carvas AO, et al. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3. EBioMedicine, 118, 105836, 2025.
- Cao J, et al. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. Nature Communications, 16, 3389, 2025.
- Gu YM, et al. Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors. Acta Pharmacologica Sinica, 47(1), 162-172, 2026.
- Wang Y, Feng Z, Yu L. The next frontier in metabolic health: Cagrilintide-Semaglutide and the evolving landscape of therapies. The Innovation Medicine, 3(3), 100150, 2025.
- Fletcher MM, et al. AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors: Pharmacological Comparison with Six Selective and Nonselective Agonists. JPET, 377(3), 417-440, 2021.
- Dahl K, et al. NN1213 – A Potent, Long-Acting, and Selective Analog of Human Amylin. Journal of Medicinal Chemistry, 67(14), 11688–11700, 2024.
- Becerril S, Frühbeck G. Cagrilintide plus semaglutide for obesity management. Lancet, 397(10286), 1687-1689, 2021.
- D'Ascanio AM, et al. Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity. Cardiology in Review, 32(1), 83-90, 2024.
- Mikhail N, Wali S. Cagrilintide Combined with Semaglutide: A New Approach for Treatment of Obesity and Type 2 Diabetes. Clinical Trials and Clinical Research, 2(5), 2023.
- Hales CM. Expanding the Treat-to-Target Toolbox for Obesity and Diabetes Care. New England Journal of Medicine, 393(7), 712-714, 2025.
- Gadde KM, Allison DB. Long-acting amylin analogue for weight reduction. Lancet, 398(10317), 2132-2134, 2021.
- Dehestani B, et al. Amylin as a Future Obesity Treatment. Journal of Obesity & Metabolic Syndrome, 30(4), 320-325, 2021.
Related Research Questions
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