Summary
Cagrilintide is a long-acting amylin analogue developed by Novo Nordisk, designed to mimic the satiety hormone amylin. It is primarily being developed in combination with semaglutide as 'CagriSema' — a once-weekly co-formulation targeting both amylin and GLP-1 pathways. Phase 3 topline results (REDEFINE-2) reported in early 2025 showed CagriSema achieved superior HbA1c reduction and weight loss compared to semaglutide alone in type 2 diabetes. Cagrilintide is not a licensed medicine in the UK.
Mechanism
Cagrilintide is a long-acting amylin analogue. It mimics the endogenous hormone amylin, which is co-secreted with insulin. It promotes satiety, slows gastric emptying, and suppresses glucagon secretion, collectively reducing food intake. When combined with semaglutide (a GLP-1 receptor agonist) as CagriSema, it targets two complementary pathways for enhanced weight loss and glycaemic control.
Evidence base
Phase 3 topline results (REDEFINE-2, reported March 2025) show CagriSema achieving superior HbA1c reduction and weight loss vs semaglutide alone in type 2 diabetes. Full peer-reviewed publication is pending. Phase 2 data (Lancet 2021) demonstrated significant weight loss for cagrilintide alone and in combination with semaglutide. Evidence quality: moderate (Phase 3 topline but not yet fully published; Phase 2 peer-reviewed).
Protocols
Once-weekly subcutaneous injection. CagriSema co-formulation: cagrilintide 2.4 mg + semaglutide 2.4 mg. Cagrilintide alone: 0.3–2.4 mg once weekly. Dose titration is used to manage gastrointestinal side effects. Trial durations: 26–68 weeks.
UK legal status
Cagrilintide is an investigational compound, not a licensed medicine in the UK. It is not a controlled substance. Purchase and possession for research purposes is generally legal, but it cannot be marketed or sold as a medicine. The MHRA continues pharmacovigilance monitoring of metabolic agents.
References
- Novo Nordisk. Novo Nordisk announces headline results from REDEFINE-2. Press release, March 2025. Available at: https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=166301
- Lau CW, et al. Once-Weekly Cagrilintide for Weight Loss in People with Obesity and Type 2 Diabetes. Lancet 2021. DOI: 10.1016/S2213-8587(21)00152-X.
- ClinicalTrials.gov. REDEFINE-2 — CagriSema in Type 2 Diabetes. Available at: https://clinicaltrials.gov
- MHRA Drug Safety Update: GLP-1 Receptor Agonists. Available at: https://www.gov.uk/drug-safety-update