CagriSema (cagrilintide plus semaglutide)
CagriSema pairs the amylin analog cagrilintide with semaglutide in one weekly injection. Novo Nordisk filed it with the FDA in December 2025, and no approval is recorded yet.
Also searched as: cagrisema, cagri-sema, cagrilintide semaglutide, CagriSema FDA, cagri sema.
Educational information. This page does not give dosing instructions or tell you what to take. Ask a prescriber about your own care.
In plain English
CagriSema combines two medicines in one weekly injection. Semaglutide is the GLP-1 drug in Wegovy and Ozempic. Cagrilintide imitates amylin, a hormone released from the pancreas alongside insulin that helps you feel full. Pairing them switches on two different appetite signals instead of one.
In the REDEFINE 1 trial, adults without diabetes lost about 20% of their body weight over 68 weeks on average, compared with 3% on placebo. In adults with type 2 diabetes (REDEFINE 2) the figure was about 14%. Both trials are published in the New England Journal of Medicine and were paid for by the maker, Novo Nordisk.
In a head-to-head trial against tirzepatide (REDEFINE 4), Novo Nordisk reported that CagriSema did not meet its goal of being at least as effective. Those results come from a company announcement, and the announcement did not say they would be published in a journal. The medicine is not approved. Novo Nordisk announced in December 2025 that it had applied to the FDA.
Brand names and products
A generic name identifies the drug itself. A brand name identifies one company's product. One drug can come in several products with different forms and approved uses, so the brand name often tells you more about what a prescription is for.
No brand name is recorded for this medicine because there is no approved product.
Approved and investigational. Every use of CagriSema is investigational or under review. There is no approved product.
How it works
Cagrilintide is a long-acting analog of amylin and activates amylin receptors, which are linked to fullness after meals and slower stomach emptying. Semaglutide activates the GLP-1 receptor, which lowers appetite and raises insulin release after eating. The two are given together at the same strength (2.4 mg each) in the trials. Cagrilintide on its own produced less weight loss than the combination in REDEFINE 1.
Forms and approval status
| Form | How it is taken | U.S. status |
|---|---|---|
| CagriSema injection (under FDA review) | Once weekly in trials. Weekly injection used in trials only. It is not available as an approved product. | Not approved. Novo Nordisk announced on December 18, 2025 that it had submitted a new drug application to the FDA, based on the REDEFINE 1 and REDEFINE 2 trials. No approval was recorded as of mid-October 2026. Novo Nordisk said only that the FDA was expected to review the application in 2026; some third-party trackers report a decision in the fourth quarter of 2026, but the company has not confirmed a date. |
What the trials found
These are group averages from published trials in adults without diabetes unless stated. See how to read trial numbers before comparing.
REDEFINE 1
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 3,417 adults with obesity, or overweight plus an obesity-related condition, without diabetes
- Length
- 68 weeks
- Compared with
- Placebo, with lifestyle support in all groups. Semaglutide-alone and cagrilintide-alone groups were also included
- What was measured
- Average change in body weight at week 68
- Analysis approach
- Treatment-policy estimand: effects regardless of treatment discontinuation
- Other results
- The gap from placebo was 17.3 percentage points. More people on CagriSema than placebo reached weight losses of at least 5%, 20%, 25% and 30% (percentages are in the full paper).
- Safety
- Gastrointestinal side effects affected 79.6% on CagriSema vs 39.9% on placebo. They were mostly temporary and mild to moderate.
- Limits
- Funded by the manufacturer. Participants did not have diabetes. The semaglutide-alone and cagrilintide-alone results are not shown here because the abstract does not list them. Group averages do not predict one person's result.
Sources: Garvey WT 2025
REDEFINE 2
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 1,206 adults with obesity or overweight and type 2 diabetes
- Length
- 68 weeks
- Compared with
- Placebo, with lifestyle support in both groups
- What was measured
- Average change in body weight at week 68
- Analysis approach
- Treatment-policy estimand: effects regardless of treatment discontinuation
- Other results
- The gap from placebo was 10.4 percentage points. A blood sugar level (HbA1c) of 6.5% or lower was reached by 73.5% on CagriSema vs 15.9% on placebo.
- Safety
- Gastrointestinal side effects affected 72.5% on CagriSema vs 34.4% on placebo. Most were temporary and mild or moderate.
- Limits
- Funded by the manufacturer. All participants had type 2 diabetes, so results may not match people without it. Group averages do not predict one person's result.
Sources: Davies MJ 2025
Safety
Summarized from FDA-approved labels of medicines in this class. The official label is the controlling source for warnings. The points below are a summary and may be incomplete.
Boxed warning and label notes
- CagriSema injection (under FDA review): Not applicable until approval.
Warnings labels describe
- Not approved, so no official label exists. Safety information is limited to trial reports.
- Semaglutide, one of the two ingredients, carries a boxed warning on its own label about thyroid C-cell tumors seen in rodents. What the label for CagriSema would say is unknown.
Most common in trials
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
Less common but serious
- The published abstracts do not list serious side effects. Full lists are in the papers and, if approved, will be in the official label.
- Gastrointestinal side effects overall affected about 80% of people without diabetes on CagriSema (vs 40% on placebo) in REDEFINE 1.
What is still unknown
- Whether and when the FDA will approve it, for which people, and what the final label will say.
- How it compares with tirzepatide. The one head-to-head trial reported so far (REDEFINE 4, 809 adults, 84 weeks, open label) came from a company announcement. If everyone had stayed on treatment as planned, weight loss was 23.0% on CagriSema vs 25.5% on tirzepatide 15 mg. Counting everyone regardless of whether they stayed on treatment, it was 20.2% vs 23.6%. Novo Nordisk said the trial did not show CagriSema to be at least as effective. The results have not been published in a journal.
- Whether it lowers the risk of heart attacks and strokes. REDEFINE 3, with about 7,000 adults with heart disease, is still running.
- Long-term safety and how much weight returns after stopping.
Compiled from public information: FDA-approved labels, manufacturer websites, ClinicalTrials.gov and published journal articles. Sources are listed at the bottom of this page.
Sources
- Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management Novo Nordisk company announcement, December 18, 2025. Company announcement; not peer reviewed. Company announcement, not peer reviewed
- CagriSema FDA approval status 2026: decision timeline Remy Research, last checked October 12, 2026. Third-party tracker citing Novo Nordisk statements; secondary source. Trade press, secondary source
- ClinicalTrials.gov U.S. National Library of Medicine. Trial registry
- REDEFINE 4 trial record, CagriSema vs tirzepatide (NCT06131437) ClinicalTrials.gov identifier NCT06131437. Trial registry
- CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity; the primary endpoint was not achieved Novo Nordisk company announcement No 13/2026, February 23, 2026. Company announcement; not peer reviewed. Company announcement, not peer reviewed
- Wegovy (semaglutide) injection and tablets: prescribing information Novo Nordisk, on DailyMed (U.S. National Library of Medicine). Label version 6/2026. One label covers both the injection and the tablets. Official FDA label on DailyMed
- Mechanisms of action and therapeutic application of glucagon-like peptide-1 Drucker DJ. Cell Metab. 2018;27(4):740-756. PMID 29617641. Journal article
- Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1) Garvey WT, et al. N Engl J Med. 2025;393(7):635-647. PMID 40544433. Funding: Novo Nordisk. Journal article
- Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2) Davies MJ, et al. N Engl J Med. 2025;393(7):648-659. PMID 40544432. Funding: Novo Nordisk. Journal article