Medicine and research reference
Cagrilintide
What human trials of this amylin analogue show, their limits, and the current U.S. regulatory context.
Source and review status
Published sources checked
Sources checked on: 6 September 2026
Qualified clinical review: Pending. This page has not been clinically reviewed.
About this source check
AI-assisted editorial source checking covers the cited material and its stated limits. It is not a systematic review, verification of a supplied product, or clinical sign-off.
Editorial role: InfoAddict. Last material change: 6 September 2026. Next source review: 6 December 2026.
What it is
Cagrilintide is a long-acting analogue of amylin, a hormone involved in fullness. It is a different molecule from semaglutide, the GLP-1 medicine with which it has also been studied.
Sources: Lau and colleagues, The Lancet; indexed by PubMed, Garvey and colleagues, New England Journal of Medicine; indexed by Europe PMC
Human research
A 2021 phase 2 trial randomised 706 adults with overweight or obesity, without diabetes, to cagrilintide, liraglutide or placebo. Over 26 weeks, weight reductions were greater in the cagrilintide groups than with placebo. Novo Nordisk funded the trial. These results concern its defined participants and study product, rather than every product bearing the ingredient name.
Safety and product status
Gastrointestinal effects, including nausea, constipation and diarrhoea, and local reactions were prominent in the trial. A weight outcome does not establish long-term safety or a benefit for a different health condition.
At the source check, FDA states that cagrilintide is not a component of an FDA-approved medicine. This is a U.S. statement; it does not establish registration in another country.
Sources: U.S. Food and Drug Administration
Published sources
- 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 and colleagues, The Lancet; indexed by PubMed. Published 16 November 2021 online; accessed 6 September 2026.
Supports: Amylin-analogue identity and a 706-participant trial, including gastrointestinal adverse events. Not evidence for a retatrutide mixture.
- Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity
Garvey and colleagues, New England Journal of Medicine; indexed by Europe PMC. Published 22 June 2025 online; accessed 6 September 2026.
Supports: REDEFINE 1: 3,417 participants, 68-week weight outcomes and adverse events for the studied combination.
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
U.S. Food and Drug Administration. Current FDA reference; accessed 6 September 2026.
Supports: U.S. status of retatrutide and cagrilintide and concerns about unapproved products sold for human use.
Change history
| Date | Change | Clinical-review status |
|---|---|---|
| 6 September 2026 | Source-linked reference published | Pending |
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