Cagrilintide: clinical evidence record
Also known as: AM833, NNC0174-0833, Long-acting amylin analogue
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-07-19
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AI-friendly summary · Cagrilintide
Novo Nordisk investigational compound. A phase 1b combination study and a phase 2 dose-finding trial were published in The Lancet in 2021, a phase 2 combination trial in type 2 diabetes in 2023, and phase 3 results for the fixed-dose cagrilintide and semaglutide combination (CagriSema) in the New England Journal of Medicine in 2025 and The Lancet Diabetes and Endocrinology in 2026. Reported adverse events across the programme are predominantly gastrointestinal (nausea, vomiting, constipation) and drive most treatment discontinuation. Cagrilintide has no marketing authorisation in the United Kingdom and is not licensed anywhere as at July 2026: a US application for the combination product was filed in December 2025 and remains under review. Anything sold as cagrilintide outside a clinical trial is unlicensed, of unverified identity and purity, and falls squarely inside the category the MHRA targeted in its largest ever seizure of unlicensed weight-loss medicines on 28 May 2026, which explicitly named peptide products alongside retatrutide and tirzepatide.
Mechanism of action
How Cagrilintide works
Acylated long-acting analogue of human amylin, the beta-cell hormone co-secreted with insulin. Non-selective agonist at the calcitonin receptor and the amylin receptor complexes AMY1 to AMY3. Preclinical work locates the bodyweight effect at amylin receptors 1 and 3 in the brain, with a lipidation strategy giving a half-life compatible with once-weekly dosing.
Top peer-reviewed citations
Selection of the most-cited peer-reviewed literature on Cagrilintide. Where a verified PMID or DOI is shown, the citation links to the original record. Other citations list the title, authors, journal and year so the reader can locate the paper through the journal index or the PubMed search linked below. PeptideClear publishes editorial commentary, not clinical guidance.
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Development of Cagrilintide, a Long-Acting Amylin Analogue
Kruse T, Hansen JL, Dahl K, et al.. Journal of medicinal chemistry, 2021.
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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
Lau DCW, Erichsen L, Francisco AM, et al.. Lancet (London, England), 2021.
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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
Enebo LB, Berthelsen KK, Kankam M, et al.. Lancet (London, England), 2021.
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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
Frias JP, Deenadayalan S, Erichsen L, et al.. Lancet (London, England), 2023.
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Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity
Garvey WT, Blüher M, Osorto Contreras CK, et al.. The New England journal of medicine, 2025.
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Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study
Buse JB, Bajaj HS, Dalskov SM, et al.. The lancet. Diabetes & endocrinology, 2026.
Full PubMed search: https://pubmed.ncbi.nlm.nih.gov/?term=cagrilintide.
Registered clinical trials
As of 2026-07-13, no interventional trials for Cagrilintide are listed on ClinicalTrials.gov or the ISRCTN registry. This is itself informative: much of the Cagrilintide evidence base is preclinical, which is why the evidence grade above matters.
Source: ClinicalTrials.gov and the ISRCTN registry, refreshed 2026-07-13. See the peptide clinical-trials tracker for the full picture across compounds.
UK regulatory status
Plain-English summary of where Cagrilintide sits under the four UK and international frameworks that govern peptide supply. Editorial commentary, not legal advice.
- Misuse of Drugs Act 1971: Not controlled under the Misuse of Drugs Act 1971.
- Psychoactive Substances Act 2016: Not scheduled under the Psychoactive Substances Act 2016.
- MHRA medicines classification: No UK marketing authorisation as a medicine.
- WADA Prohibited List: Not currently listed on the WADA Prohibited List.
Risks and unknowns
What the literature does not yet show about Cagrilintide
Known concerns
- Cagrilintide has been studied in randomised human trials, which is a materially stronger position than most compounds on this site. Trial populations, endpoints and durations are still narrower than everyday use, so results describe the trial, not every person.
- The body of published work on Cagrilintide is small, at 6 papers in our record. A thin literature means individual findings carry more weight than they should, and one contrary result can change the picture.
- There are no registered interventional clinical trials for Cagrilintide on ClinicalTrials.gov or the ISRCTN registry. Nobody is currently running the study that would answer the safety and efficacy questions.
- Cagrilintide holds no UK marketing authorisation, so nothing you can buy has been assessed by a regulator, released by batch, or dispensed by an accountable pharmacy. Purity, dose accuracy and sterility rest entirely on the seller's own documentation.
Open questions in the literature
- Long-term outcomes beyond the duration of the published trials are unknown, and the published trials are considerably shorter than the periods over which people actually use these compounds.
- Interactions between Cagrilintide and prescribed medicines are not systematically studied, which matters most for anyone already on treatment for a long-term condition.
- Effects on body composition, and whether any change is maintained after stopping, are among the least well characterised parts of the metabolic literature.
Regulatory note
No UK marketing authorisation as a medicine. Not currently listed on the WADA Prohibited List. The moment a UK seller or commentator makes a therapeutic claim, MHRA can treat the product as an unlicensed medicinal product.
Important: PeptideClear publishes encyclopedia commentary only and does not recommend human use. Speak to a UK-registered prescriber before any medical decision.
Related reading on PeptideClear
Frequently asked questions
What is the evidence level for Cagrilintide?
What is the UK regulatory status of Cagrilintide?
Has Cagrilintide been tested in human clinical trials?
Where can I read the source literature for Cagrilintide?
Last verified 2026-07-19. Editorial commentary, not legal or clinical advice. Citations without a linked identifier can be located through the PubMed search and the journal index.