Short answer: cagrilintide is a long-acting amylin analogue from Novo Nordisk, and its key data come from the REDEFINE 1 phase 3 trial (NEJM, 2025). On its own, it produced about 11.8% weight loss at 68 weeks. Combined with semaglutide as “CagriSema,” it reached about 22.7%, versus 16.1% for semaglutide alone and 2.3% for placebo. The trade-off is the same as with other incretin-era drugs: gastrointestinal side effects in roughly four out of five people on the combination. Here is what the trial showed.
What amylin and cagrilintide do
Amylin is a hormone released by the pancreas alongside insulin after meals. It slows stomach emptying and signals fullness to the brain. Natural amylin lasts minutes and clumps easily; cagrilintide was engineered to last about a week, allowing once-weekly injection. Because amylin and GLP-1 act on partly different appetite pathways, combining them was expected to add up, and REDEFINE 1 tested exactly that. For the broader GLP-1 landscape, see retatrutide vs tirzepatide vs semaglutide.
REDEFINE 1 in numbers
3,417 adults with obesity or overweight (without diabetes), 68 weeks, randomized and double-blind.
| Arm | Participants | Weight change (on treatment) |
|---|---|---|
| CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) | 2,108 | −22.7% |
| Semaglutide alone | 302 | −16.1% |
| Cagrilintide alone | 302 | −11.8% |
| Placebo | 705 | −2.3% |
In the intention-to-treat analysis, CagriSema produced −20.4% vs −3.0% for placebo. In REDEFINE 2, in people with type 2 diabetes, CagriSema produced −13.7% vs −3.4%. A later head-to-head trial against tirzepatide (REDEFINE 4) did not meet its primary non-inferiority endpoint.
Side effects
- Gastrointestinal effects (nausea, vomiting, diarrhea, constipation) were the main adverse events: about 80% on CagriSema vs about 40% on placebo in REDEFINE 1, and 72.5% on CagriSema in REDEFINE 2.
- Most were mild to moderate and concentrated during dose escalation; investigators attributed relatively low discontinuation to flexible dosing.
- Cagrilintide alone is generally reported as better tolerated than the combination, but with less weight loss.
- As with any significant weight loss, gallbladder problems and loss of lean mass are recognized considerations for this drug class.
Regulatory status
| FDA (USA) | Novo Nordisk filed CagriSema with the FDA in December 2025. Check current status before relying on any approval claim. |
|---|---|
| Health Canada | Not approved. Research-grade cagrilintide sold online is an unauthorized drug. |
| Sport | Not approved for human use; athletes in tested sport should treat it as prohibited under WADA’s non-approved substances rule. |
See TrueLabs Cagrilintide and its COA →
Frequently asked questions
Cliquez sur une question pour afficher la réponse.
How much weight loss did cagrilintide cause?
In REDEFINE 1, cagrilintide alone produced about 11.8% weight loss at 68 weeks; combined with semaglutide (CagriSema), about 22.7%, vs 2.3% with placebo.
What are the side effects of cagrilintide?
Mainly gastrointestinal: nausea, vomiting, diarrhea and constipation. About 80% of people on CagriSema had GI adverse events vs about 40% on placebo, mostly mild to moderate.
What is CagriSema?
CagriSema is a once-weekly combination of cagrilintide (an amylin analogue) and semaglutide (a GLP-1 agonist) developed by Novo Nordisk.
Is cagrilintide approved?
Not in Canada. CagriSema was submitted to the US FDA in December 2025.
How is amylin different from GLP-1?
Both reduce appetite and slow stomach emptying, but they act through different receptors and brain pathways, which is why combining them adds to weight loss.
Related reading
References
- Garvey WT, et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). N Engl J Med. 2025. DOI
- TCTMD. Amylin analogue boosts weight loss when added to GLP-1. TCTMD
- Drugs.com. CagriSema FDA approval status. Drugs.com
All TrueLabs products are sold for in vitro and laboratory research use only. They are not intended for human or veterinary use, and nothing in this article is medical advice.