What it is
Cagrilintide is a long-acting, lipidated analogue of amylin, a pancreatic hormone involved in satiety, developed by Novo Nordisk for obesity research. It has been studied alone and, more often, in a once-weekly combination with semaglutide known as CagriSema. Cagrilintide is not approved as a medicine on its own; the combination has reported Phase 3 results in obesity and type 2 diabetes.
How it works
It activates amylin receptors, a pathway studied for satiety, slower gastric emptying, and suppression of glucagon after meals. Research pairs it with semaglutide on the hypothesis that amylin and GLP-1 signalling have complementary effects on glycaemic control and body weight.
Regulatory status
- Cosmetic ingredient
- Research compound
- In clinical trials
- Approved medicine
In human clinical trials and not yet approved by the FDA or the EMA. Results to date are from trial populations under medical supervision.
What published research is studying
- Weight reduction with cagrilintide alone in adults with overweight or obesity (Phase 2)
- Weight reduction with cagrilintide plus semaglutide in adults with overweight or obesity, with and without type 2 diabetes (Phase 3)
- Glycaemic control in type 2 diabetes compared with semaglutide or cagrilintide alone (Phase 2 and Phase 3)
- Pharmacokinetics, tolerability, and gastrointestinal adverse events across dose levels
Key findings
In a 26-week Phase 2 dose-finding trial in 706 adults with overweight or obesity, mean weight reduction ranged from 6.0% to 10.8% across cagrilintide doses, against 3.0% with placebo, and the 4.5 mg group lost 10.8% against 9.0% with liraglutide 3.0 mg.
Lau DCW et al., Lancet 2021In a 32-week Phase 2 trial in 92 adults with type 2 diabetes, mean body weight fell 15.6% with cagrilintide plus semaglutide, 8.1% with cagrilintide alone, and 5.1% with semaglutide alone, while HbA1c fell 2.2, 0.9, and 1.8 percentage points respectively.
Frias JP et al., Lancet 2023In the 68-week Phase 3 REDEFINE 1 trial in 3,417 adults with overweight or obesity without diabetes, mean body weight fell 20.4% with cagrilintide plus semaglutide, against 3.0% with placebo, and gastrointestinal adverse events affected 79.6% and 39.9% of the two groups.
Garvey WT et al., N Engl J Med 2025In the 68-week Phase 3 REDEFINE 2 trial in 1,206 adults with overweight or obesity and type 2 diabetes, mean body weight fell 13.7% with the combination, against 3.4% with placebo, and 73.5% reached an HbA1c of 6.5% or less, against 15.9%.
Davies MJ et al., N Engl J Med 2025In a Phase 1b trial in 96 adults with overweight or obesity, cagrilintide showed a half-life of 159 to 195 hours, and at week 20 the 2.4 mg cagrilintide group, given alongside semaglutide 2.4 mg, had lost 17.1% of body weight against 9.8% with semaglutide plus placebo.
Enebo LB et al., Lancet 2021
What the studies measured
Study durations
- Phase 2 monotherapy trial: 26 weeks of treatment, including up to 6 weeks of dose escalation, then 6 weeks of follow-up (NCT03856047).
- Phase 2 type 2 diabetes trial: 32 weeks (NCT04982575).
- Phase 3 combination trials with semaglutide: 68 weeks (NCT05567796, NCT05394519).
- Phase 1b combination trial: 16 weeks of dose escalation, 4 weeks at target dose, then 5 weeks of follow-up (NCT03600480).
Endpoints
- Percent change in body weight from baseline
- Proportion reaching 5%, 20%, 25%, or 30% weight reduction
- Change in HbA1c and fasting plasma glucose
- Continuous glucose monitoring time in range
- Gastrointestinal adverse events, half-life, and treatment discontinuation
How strong is the evidence?
Human evidence includes large randomised Phase 3 trials, but almost all of it tests cagrilintide combined with semaglutide; data on cagrilintide alone come mainly from one 26-week Phase 2 trial and smaller comparison arms.
Common questions
Is Cagrilintide an approved medicine?
In clinical trials. In human clinical trials and not yet approved by the FDA or the EMA. Results to date are from trial populations under medical supervision.
How much human research is there on Cagrilintide?
Human evidence includes large randomised Phase 3 trials, but almost all of it tests cagrilintide combined with semaglutide; data on cagrilintide alone come mainly from one 26-week Phase 2 trial and smaller comparison arms.
Does UU supply Cagrilintide?
Yes, as premium-grade research material for laboratory use. Every batch is tested by an independent lab and the certificate of analysis is published.