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CagriSema is an investigational combination of two peptides developed by Novo Nordisk: cagrilintide, a long-acting version of the hormone amylin, and semaglutide, the GLP-1 receptor agonist in Ozempic and Wegovy. The combination is not FDA-approved. Novo Nordisk submitted an application for weight management to the FDA on December 18, 2025, and has said it expects a decision by late 2026.
Semaglutide is approved on its own, but that does not make the combination approved. The FDA reviews each product separately.
The two parts act on different hormone systems involved in appetite. Semaglutide mimics GLP-1, a gut hormone released after eating that slows stomach emptying and signals fullness. Cagrilintide mimics amylin, a hormone the pancreas releases along with insulin that also signals fullness. Combining them was designed to produce more weight loss than either one alone.
Amylin-based medicines are not new in themselves. Pramlintide (Symlin), a short-acting amylin analogue, has been FDA-approved for diabetes since 2005. Cagrilintide is a newer, longer-acting analogue.
REDEFINE 1, published in the New England Journal of Medicine in 2025, enrolled 3,417 adults with obesity or overweight who did not have type 2 diabetes. After 68 weeks, average body weight changed by 20.4 percent with CagriSema and by 3.0 percent with placebo.
REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and overweight or obesity. After 68 weeks, average weight change was 13.7 percent with CagriSema and 3.4 percent with placebo.
REDEFINE 4 compared CagriSema head to head with tirzepatide, the active ingredient in Zepbound, over 84 weeks in an open-label trial. On February 23, 2026, Novo Nordisk announced that the trial did not meet its main goal of showing that CagriSema was non-inferior, meaning not meaningfully worse, than tirzepatide. Counting everyone assigned to each drug, average weight loss was 20.2 percent with CagriSema and 23.6 percent with tirzepatide.
Current status: Investigational – not FDA-approved.
The application Novo Nordisk filed in December 2025 was based on REDEFINE 1 and REDEFINE 2. As of late September 2026, we found no announcement of an FDA decision. Until the FDA approves it, CagriSema is available only to people taking part in authorized clinical trials.
No FDA-approved product contains cagrilintide. Products sold online as cagrilintide or "CagriSema" are not approved medicines and are not the Novo Nordisk product tested in these trials. The FDA has not reviewed their contents or quality.
In REDEFINE 1, gastrointestinal side effects were the most common problem, reported by about 80 percent of people on CagriSema compared with about 40 percent on placebo. Novo Nordisk reported that most were mild to moderate and eased over time.
Semaglutide products approved in the United States carry a boxed warning about thyroid C-cell tumors seen in rodent studies. If CagriSema is approved, its own FDA label will set out its warnings.
Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, we do not supply, prepare or distribute CagriSema in any form, and nothing on this page should be read as an offer.
If you have questions about CagriSema or about weight management medicines, talk to a licensed healthcare provider who knows your medical history.
See the full list of compound profiles in the Peptide Guide. For the two ingredients, see our profiles of cagrilintide and semaglutide. You can also read our overview of peptides for weight loss and our comparison of semaglutide vs. tirzepatide.
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