Long-acting amylin (and calcitonin) receptor agonist / amylin analogue
Cagrilintide
Investigationalaka AM833, NNC0174-0833
Cagrilintide is an experimental amylin-based peptide developed to reduce appetite and body weight, studied both alone and combined with semaglutide (CagriSema). Phase 2 monotherapy data and Phase 3 CagriSema data (REDEFINE in obesity, REIMAGINE in type 2 diabetes) report substantial weight reductions. It remains investigational and is not authorized for clinical use.
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Mechanism
In plain terms, cagrilintide mimics amylin, a hormone released with insulin that promotes fullness and slows digestion. Technically, it is a long-acting amylin analogue that agonizes amylin and calcitonin family receptors, reducing food intake, slowing gastric emptying, and enhancing satiety through central and peripheral pathways. Its mechanism is complementary to GLP-1 receptor agonism, which is the rationale for combining it with semaglutide in CagriSema.
Regulatory Status by Region
- United States (FDA)Investigational; not approved as a standalone product. As part of the CagriSema combination (with semaglutide), a new drug application has been filed and an FDA decision is expected later in 2026.
- Australia (TGA)Not entered on the ARTG; investigational only and not approved for supply.
- European Union (EMA)Not authorized; investigational, no marketing authorization.
- WADANot listed on the WADA Prohibited List. Amylin analogues are not banned substances; as an investigational agent it falls outside approved therapeutic use.
Key Studies
- Once-weekly cagrilintide for weight management in people with overweight and obesity: a dose-finding phase 2 trial (Lau et al.) (opens in a new tab) (Lancet 2021;398:2160-2172; DOI 10.1016/S0140-6736(21)01751-7; PMID 34798060)
- Safety, tolerability, pharmacokinetics of concomitant cagrilintide and semaglutide (Phase 1b; Enebo et al.) (opens in a new tab) (Lancet 2021;397:1736-1748; DOI 10.1016/S0140-6736(21)00845-X; PMID 33894838)
- A Research Study of How Well CagriSema Works in People Living With Overweight or Obesity (REDEFINE 1, Phase 3) (opens in a new tab) (ClinicalTrials.gov NCT05567796)
Related Clinical Trials
- A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 DiabetesPhase 2 · Withdrawn
- A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body WeightPhase 3 · Not Yet Recruiting
- A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 DiabetesPhase 3 · Not Yet Recruiting
- A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body WeightPhase 3 · Withdrawn
- Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse EventsPhase 1 · Recruiting
- A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose WeightPhase 3 · Recruiting
- A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body WeightPhase 1 · Active Not Recruiting
- A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or ObesityPhase 1 · Recruiting
Related News & Research
- This Week in Peptide Research: Survodutide's Phase 3 Obesity Data, Mazdutide's US Phase 2 Trial, and a Bone-Peptide Cluster
- This Week in Peptide Research: Bone-Building Peptide Mechanisms, Real-World GLP-1 Data, and a Reproductive-Axis Cluster
- This Week in Peptide Research: GIP Receptor Debate, Bone-Building Peptides, and New Safety Signals
- Zalfermin Plus Semaglutide Misses Its Primary Endpoint in Phase 2 Liver Fibrosis Trial
- BMJ Network Meta-Analysis Compares 19 Obesity Drugs on Weight Loss, Heart Risk, and Side Effects
Latest research
- Maximizing weight loss with cagrisema: a systematic review and GRADE-assessed meta-analysis of randomized controlled trials. (opens in a new tab)
Naunyn-Schmiedeberg's archives of pharmacology · Aug 17, 2026
Common Questions
- What is Cagrilintide?
- Cagrilintide is an investigational once-weekly long-acting amylin analogue from Novo Nordisk being studied for weight management, most prominently in a fixed-dose combination with semaglutide called CagriSema. As of 2026 it is not approved by any regulator; a CagriSema new drug application has been filed with the FDA with a decision expected later in 2026.
- Is Cagrilintide approved for medical use?
- Cagrilintide is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Investigational; not approved as a standalone product. As part of the CagriSema combination (with semaglutide), a new drug application has been filed and an FDA decision is expected later in 2026. European Union (EMA): Not authorized; investigational, no marketing authorization. Australia (TGA): Not entered on the ARTG; investigational only and not approved for supply.
- How does Cagrilintide work?
- In plain terms, cagrilintide mimics amylin, a hormone released with insulin that promotes fullness and slows digestion. Technically, it is a long-acting amylin analogue that agonizes amylin and calcitonin family receptors, reducing food intake, slowing gastric emptying, and enhancing satiety through central and peripheral pathways.
- Is Cagrilintide legal in Australia?
- Cagrilintide in Australia (TGA): Not entered on the ARTG; investigational only and not approved for supply.
- Is Cagrilintide banned in sport?
- Cagrilintide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List. Amylin analogues are not banned substances; as an investigational agent it falls outside approved therapeutic use.