Cagrilintide

BInvestigationalCagriSema (with semaglutide)amylin analogueAM833
In one paragraphCagrilintide is a once-weekly analogue of amylin, a hormone the pancreas releases alongside insulin that signals fullness. On its own it produced about 12% weight loss over 68 weeks; combined with semaglutide as CagriSema it produced 22.7% in a 3,417-person phase 3 trial published in the New England Journal of Medicine. Neither is approved yet, and the combination missed the 25% figure its developer had signalled.
Schematic 3D structure of Cagrilintide
37 residues · amylin analogue, helical · schematic
Overall gradeB Probable
Human trialsPhase 3 published
Outcomes graded3
Last reviewed2 September 2026
EvidenceWhat it isHow it worksUnknownsRegulationQuestionsReferences

What the human research shows

The first serious non-incretin addition to the weight-loss toolkit. The combination data are published and large, which is why the grade is B rather than D — but nothing is approved, and the standalone effect is modest next to what it is combined with.

OutcomeGradeEffect sizeHuman studiesWhere the evidence comes from
Body weight (with semaglutide, CagriSema)BProbableLarge1 large phase 3 RCTREDEFINE 1: −22.7% at 68 weeks in 3,417 adults vs −16.1% semaglutide alone, −11.8% cagrilintide alone, −2.3% placebo. 40.4% lost at least a quarter of body weight.1
Body weight (alone)BProbableModeratePhase 2 + phase 3 arm−11.8% at 68 weeks as monotherapy in REDEFINE 1 — meaningful, but below the incretin drugs.1
GI side effectsadverseBProbableModeratePhase 3Mostly mild-to-moderate nausea and vomiting, easing over time; the profile reported as consistent with GLP-1 drugs.1
AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 2 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

What it is

Amylin is co-secreted with insulin and slows gastric emptying and promotes satiety. An earlier analogue, pramlintide, required several injections a day. Cagrilintide is engineered to last a week, which is what makes a combination product practical.

Novo Nordisk's strategy is the combination: cagrilintide plus semaglutide in one injection, branded CagriSema, on the theory that two different satiety pathways add up. REDEFINE 1 is the trial that tested it.

How it is thought to work

Amylin receptors in the brainstem contribute to meal termination through a pathway distinct from GLP-1. Because the mechanisms differ, the effects appear at least partly additive rather than redundant — which is the case for the combination.

What is still unknown

  • Whether it will be approved, and when.
  • Long-term durability and what happens on stopping.
  • Whether the modest standalone effect has a role of its own.

Regulatory status

European Union
Not authorised — investigational

Under development; no marketing authorisation.

United States
Not approved

Phase 3 complete for CagriSema; filing and review pending.

Canada
Not authorised

No Health Canada authorisation; not prescribable.

Questions people actually ask

Is CagriSema better than semaglutide?
In REDEFINE 1, yes: 22.7% versus 16.1% at 68 weeks in the same trial. It fell short of the 25% figure the market had expected, which is why the result was reported as a disappointment despite being the larger number.
What is amylin?
A hormone released with insulin after eating that signals fullness and slows stomach emptying. Cagrilintide is a version engineered to last about a week.
Can you buy cagrilintide?
Not legally. It is investigational; anything sold under the name is unlicensed and of unknown content.

References

  1. 1
    Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).N Engl J Med, 2025; DOI 10.1056/NEJMoa25020813,417 adults, 68 weeks, four arms.

Change log

  • 2026-09-02Initial publication from the published REDEFINE 1 trial.