Cagrilintide[AM833; the amylin component of CagriSema]
Compound snapshot
Class
Long-acting amylin analogue
FDA approved
No — investigational
Clinical development
Phase 3
Last reviewed
September 2026
Research areas
Body weight / Appetite regulation / Metabolic disease
Regulatory status
Investigational — not FDA-approved
Internet attention
High
Registry query
Cagrilintide
A long-acting analogue of amylin, a 37-amino-acid hormone normally released with insulin after eating. It is being studied as a standalone obesity treatment and as one half of CagriSema, its investigational combination with semaglutide.
Reality check — what we actually know
Supported by human evidence
- This compound has completed human trials in at least one approved indication — see the regulatory section for what was actually approved.
Animal research only
- Produced dose-dependent weight loss in a 26-week randomised Phase 2 trial of adults with overweight or obesity
- The highest studied Phase 2 group lost a mean 10.8% of body weight, compared with 3.0% with placebo and 9.0% with daily liraglutide
- Targets amylin signalling, providing a complementary appetite pathway to GLP-1 medicines
Mechanistically plausible
- Activates amylin and calcitonin receptor complexes involved in meal-related fullness. The signal acts in appetite-regulating brain regions, slows stomach emptying and reduces post-meal glucagon, which can lower food intake. This is a different pathway from the GLP-1 receptor activated by semaglutide.
Common internet claims
- Online discussion frequently presents Cagrilintide as a proven treatment rather than a research compound.
Not established
- Human efficacy for the outcomes commonly claimed
- Optimal route, quantity and duration in humans
- Long-term human safety
Evidence distribution
Each band is a live PubMed search for Cagrilintide, filtered to that kind of study. Top is the strongest evidence; the base is reasoning, not proof. A band with no records means that kind of study has not been published for this compound yet.
Mechanism and reported findings
Activates amylin and calcitonin receptor complexes involved in meal-related fullness. The signal acts in appetite-regulating brain regions, slows stomach emptying and reduces post-meal glucagon, which can lower food intake. This is a different pathway from the GLP-1 receptor activated by semaglutide.
- Produced dose-dependent weight loss in a 26-week randomised Phase 2 trial of adults with overweight or obesity
- The highest studied Phase 2 group lost a mean 10.8% of body weight, compared with 3.0% with placebo and 9.0% with daily liraglutide
- Targets amylin signalling, providing a complementary appetite pathway to GLP-1 medicines
- CagriSema — cagrilintide combined with semaglutide — produced an estimated 20.4% mean weight reduction at 68 weeks versus 3.0% with placebo in the Phase 3 REDEFINE 1 treatment-policy analysis
- In REDEFINE 4 (topline, February 2026), CagriSema did not meet non-inferiority against tirzepatide: 23.0% versus 25.5% weight loss at 84 weeks under the efficacy analysis
- CagriSema was filed with the FDA in December 2025 and remains under review; cagrilintide on its own is still in Phase 3
- Cagrilintide alone and CagriSema are separate investigational treatments; results from the combination cannot be attributed to cagrilintide alone
Strength of the evidence: Human evidence includes a randomised, placebo- and active-controlled Phase 2 trial of cagrilintide alone and the large Phase 3 REDEFINE and REIMAGINE programmes of CagriSema, including a head-to-head comparison with tirzepatide. These are meaningful clinical data, but cagrilintide remains investigational and has no FDA-approved indication.
Safety and known cautions
Gastrointestinal effects — especially nausea, constipation, diarrhoea and vomiting — were common in trials and were generally mild to moderate. Reduced appetite and slower stomach emptying may make adequate food and fluid intake harder. Longer-term and uncommon risks are still being defined. Do not use research-market products or change any medication without the prescribing clinician.
Evidence at a glance
No single score, on purpose. The line beside each bar shows how much reported outcomes vary between studies.
Development stage
- Discovery
- Preclinical
- Phase 1
- Phase 2
- Phase 3Current
- Regulatory review
- Approved