The CagriSema injection pairs cagrilintide and semaglutide for weight loss. Learn how it works, trial results, side effects, and its FDA approval status.
CagriSema injection is an investigational once-weekly shot that combines cagrilintide and semaglutide to treat obesity and type 2 diabetes. Novo Nordisk is developing it, and the CagriSema injection is not FDA-approved for any use in the United States, not available by prescription, and not sold legally outside of clinical trials. Early data show larger average weight loss than semaglutide alone, but the product still has to clear regulatory review before a clinician could prescribe it.
What Is the CagriSema Injection?
CagriSema is a fixed-dose combination product, which means both active ingredients arrive premixed in a single pen. Each weekly dose delivers 2.4 mg of cagrilintide and 2.4 mg of semaglutide.
- Cagrilintide is a long-acting analog of amylin, a hormone the pancreas releases alongside insulin. Amylin helps signal fullness and slows how quickly the stomach empties.
- Semaglutide is a GLP-1 receptor agonist, the same active ingredient found in Ozempic and Wegovy. It reduces appetite and food intake through brain pathways that regulate satiety.
Pairing an amylin analog with a GLP-1 is not a new idea, but CagriSema is the most advanced version of it. Researchers hope the two mechanisms act on different appetite circuits, which may produce more weight loss than either drug alone.
In trials, participants inject CagriSema under the skin of the abdomen, thigh, or upper arm once a week. Doses are raised gradually over several weeks, because starting at a high dose tends to cause severe nausea.
CagriSema Injection Clinical Trial Results
Novo Nordisk built the CagriSema program around the REDEFINE trials, a group of late-stage studies that enrolled thousands of adults. The two headline trials reported results in 2024 and 2025.
| Study | Participants | Average weight loss at 68 weeks |
|---|---|---|
| REDEFINE 1 | Adults with obesity or excess weight plus a related condition, without diabetes | 22.7% with CagriSema; 11.8% with semaglutide 2.4 mg; 2.3% with placebo |
| REDEFINE 2 | Adults with type 2 diabetes and excess weight | 15.7% with CagriSema; 3.1% with placebo |
The boldest finding from REDEFINE 1 was the comparison against semaglutide 2.4 mg: CagriSema produced roughly double the average weight loss of the current Wegovy dose inside the same trial. About 40% of people on CagriSema lost at least a quarter of their starting body weight.
Two caveats matter. These are group averages, so individual responses ranged from minimal loss to more than 30%. REDEFINE 1 also used a flexible dosing schedule, meaning not every participant reached the highest dose.
Additional studies are still running. REDEFINE 3 is testing whether CagriSema reduces cardiovascular events, and REDEFINE 4 compares it head-to-head with tirzepatide, the active ingredient in Zepbound.
CagriSema Injection Side Effects and Safety
Gastrointestinal side effects dominate the safety profile, which is typical for this drug class. In the REDEFINE trials, the most common complaints were:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Injection site reactions
Most of these symptoms were mild to moderate and became less frequent as the body adjusted. A small share of participants stopped treatment because of them.
Because semaglutide belongs to the GLP-1 class, CagriSema carries the same warnings. These include pancreatitis, gallbladder disease, low blood sugar when combined with insulin or sulfonylureas, kidney injury from dehydration, and worsening of diabetic retinopathy. The class also carries a boxed warning about thyroid C-cell tumors observed in rodents and is contraindicated for people with a personal or family history of medullary thyroid carcinoma or MEN2 syndrome.
Anyone who is pregnant, planning pregnancy, or taking other diabetes medication should talk with a healthcare professional before considering any GLP-1 or amylin-based therapy.
Is the CagriSema Injection FDA-Approved?
No. CagriSema has not been approved by the FDA or any other regulator as of this writing, and no legal prescription version exists.
Novo Nordisk has said it intends to file for regulatory approval, with submissions expected around 2026, but filing is not the same as approval. Until a decision is issued, several things simply do not exist yet:
- An approved dose for weight management or diabetes
- Published prescribing information
- A pharmacy price or insurance coverage policy
- Any legitimate compounded version
If a website claims to sell CagriSema injection with overnight shipping, it is selling a product that has never been evaluated for purity, potency, or sterility.
Beware of Research Peptide Sellers
Injectable peptides are a booming gray market, and weight-loss drugs attract the worst of it. Vendors sell freeze-dried powders labeled for research use only, and buyers are left to reconstitute them at home. A common follow-up search is what is bacteriostatic water for injection used for, because the vial arrives with no instructions and the buyer has to source bac water for injection to dissolve the powder.
That same market carries aod-9604 injection, publishes comparisons like kpv peptide oral vs injection, and advertises unapproved GLP-1 powders. Some peptides do have legitimate FDA approval for specific conditions, including vyleesi injection for low sexual desire in premenopausal women, but approval of one peptide says nothing about the safety of another. Unregulated powders can be underdosed, contaminated, or something else entirely.
How CagriSema Compares With Approved Weight Loss Injections
| Medication | Status | Active ingredients | Schedule |
|---|---|---|---|
| Wegovy | FDA-approved for chronic weight management | Semaglutide 2.4 mg (GLP-1) | Weekly injection |
| Zepbound | FDA-approved for chronic weight management | Tirzepatide (GIP and GLP-1) | Weekly injection |
| CagriSema | Investigational, not approved | Cagrilintide plus semaglutide | Weekly injection |
If you are seeking treatment now, approved options exist and are worth discussing with a clinician. CagriSema may join that list later, but that decision belongs to regulators, not to marketing pages.
Clinical trials remain the only legitimate route to the drug today, and enrollment requires meeting specific criteria. People who want to participate can search ClinicalTrials.gov or ask a healthcare professional about study sites nearby.
Frequently Asked Questions
Is the CagriSema injection available in the US yet?
No. CagriSema is investigational and has not been approved by the FDA, so it cannot be prescribed or purchased legally in the United States. The only way to receive it right now is through a clinical trial. Novo Nordisk has said it plans to file for regulatory approval, but no decision has been issued.
How much weight loss does CagriSema cause?
In the REDEFINE 1 trial, adults without diabetes lost an average of 22.7% of their body weight at 68 weeks, compared with 11.8% on semaglutide 2.4 mg and 2.3% on placebo. In REDEFINE 2, which enrolled adults with type 2 diabetes, average weight loss was 15.7% versus 3.1% with placebo. Individual results varied widely, and no one should expect a specific number.
What are the side effects of the CagriSema injection?
The most common side effects in trials were nausea, diarrhea, vomiting, constipation, and injection site reactions. Because it contains semaglutide, it also carries GLP-1 class warnings for pancreatitis, gallbladder disease, and a boxed warning about thyroid C-cell tumors seen in rodents. A healthcare professional can help weigh those risks against the benefits.
This page provides educational research information and does not replace medical advice, diagnosis, or treatment.