Quick answer: what is CagriSema?
CagriSema is an investigational once-weekly injection combining two peptides — the amylin analog cagrilintide and the GLP-1 drug semaglutide — for weight management.
New to peptides? Start with what are peptides? and how do peptides work?
Quick facts
- Class
- Fixed-dose amylin analog + GLP-1 receptor agonist
- Components
- Cagrilintide 2.4 mg + semaglutide 2.4 mg
- Maker
- Novo Nordisk
- Studied for
- Chronic weight management; type 2 diabetes
- Status
- NDA filed with FDA (Dec 2025); not yet approved
- Components
- Cagrilintide 2.4 mg + semaglutide 2.4 mg
- Key trial
- REDEFINE 1 / REDEFINE 2 (Phase 3)
- Status
- FDA review; decision expected 2026
Key takeaways
- In the Phase 3 REDEFINE 1 trial it produced about 22.7% weight loss at 68 weeks, more than either component alone.
- It would be the first approved GLP-1 plus amylin combination; Novo Nordisk filed for FDA approval in December 2025.
- It is not yet approved, and anything sold as CagriSema outside a future approved supply chain is unregulated.
Overview
CagriSema is not a new molecule but a combination of two peptides the body's weight-regulation systems respond to: cagrilintide, a long-acting analog of the satiety hormone amylin, and semaglutide, the GLP-1 receptor agonist behind Ozempic and Wegovy. Pairing them in one once-weekly injection is designed to curb appetite through two complementary pathways at once.[1]
Developed by Novo Nordisk, it would be the first approved GLP-1 plus amylin combination. Novo filed for FDA approval in December 2025, with a decision expected in 2026; it is not yet approved.
How it works
The two components hit different appetite systems. Semaglutide mimics GLP-1, slowing stomach emptying and acting on brain appetite centres. Cagrilintide mimics amylin, a hormone co-released with insulin that promotes fullness and further slows gastric emptying through a separate receptor.[1][3]
Combining a GLP-1 agonist with an amylin analog is one of the most active strategies in obesity medicine, on the theory that engaging two independent satiety pathways produces greater, more durable weight loss than either alone.
Clinical evidence
In the Phase 3 REDEFINE 1 trial, adults with overweight or obesity (without diabetes) lost roughly 22.7% of body weight at 68 weeks on CagriSema — more than semaglutide or cagrilintide alone in the same study.[1] In REDEFINE 2, in people with type 2 diabetes, it produced substantial weight loss and improved blood-sugar control.[2] Earlier Phase 2 work in type 2 diabetes established the combination's efficacy and tolerability.[3]
The side-effect profile is dominated by the gastrointestinal effects typical of this drug class. As an investigational combination, its full benefit-risk picture is still being assessed by regulators.
Safety & status
CagriSema's side effects mirror those of its components — chiefly nausea, vomiting, diarrhea, and constipation — and it carries the class considerations of GLP-1 and amylin therapies. Because it is not yet FDA-approved, it is not commercially available; products sold as "CagriSema" outside a future approved supply chain are unregulated and not quality-assured. See semaglutide and cagrilintide for the components.
Frequently asked questions
What is CagriSema?
CagriSema is a once-weekly investigational weight-loss injection that combines two peptides in one fixed dose: cagrilintide (an amylin analog) and semaglutide (the GLP-1 drug in Ozempic and Wegovy). It is under FDA review and not yet approved.
How much weight loss does CagriSema cause?
In the Phase 3 REDEFINE 1 trial, adults with overweight or obesity lost about 22.7% of body weight at 68 weeks on CagriSema — more than semaglutide or cagrilintide alone in the same study.
Is CagriSema FDA-approved?
Not yet. Novo Nordisk filed for FDA approval in December 2025, with a decision expected in 2026. Until it is approved it is not commercially available, and products sold under its name are unregulated.
How is CagriSema different from Ozempic?
Ozempic is semaglutide alone (a GLP-1 drug). CagriSema adds cagrilintide, an amylin analog, so it engages two separate appetite-regulating pathways at once, which produced greater weight loss in trials.
References
Each source links to its original record — peer-reviewed studies, regulator pages, or reference texts, labelled by type. We summarize findings neutrally; a citation is a reference, not an endorsement, and not a claim that its authors reviewed this page.
- Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025. Peer-reviewed study
- Davies MJ, Bajaj HS, Broholm C, et al. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025. Peer-reviewed study
- Frias JP, Deenadayalan S, Erichsen L, et al. Efficacy and safety of co-administered once-weekly cagrilintide with once-weekly semaglutide in type 2 diabetes: a phase 2 trial. Lancet. 2023. Peer-reviewed study