CagriSema for Weight Loss
Novo Nordisk's once-weekly combination of cagrilintide and semaglutide. Not yet FDA approved. It was filed for review in December 2025 and produced about 22.7% average weight loss in the REDEFINE 1 trial, though it lost a head-to-head trial against Zepbound.
Reviewed by GlobalGLP1 editorial team • Last reviewed March 2026 • Sources: FDA prescribing information, peer-reviewed clinical trials
Overview
CagriSema is an investigational once-weekly injection from Novo Nordisk that puts two drugs in one shot: cagrilintide, which copies a hormone called amylin, and semaglutide, the GLP-1 drug already sold as Wegovy and Ozempic. It is the first amylin and GLP-1 combination to reach the FDA. Novo Nordisk filed it for approval on December 18, 2025, for adults with obesity, or with overweight plus a weight-related health condition. The company expects a decision in the last three months of 2026. Neither the FDA nor Novo Nordisk has published a target decision date, so treat any specific day quoted elsewhere as a guess. In the main trial, REDEFINE 1, people on CagriSema lost about 22.7% of their body weight over 68 weeks. In a later trial that put it directly against Zepbound, it lost.
How CagriSema Works
CagriSema works on two hunger pathways at once instead of one. The semaglutide half copies GLP-1, the gut hormone that tells your brain you are full and slows how fast food leaves your stomach. That is the same mechanism Wegovy uses. The cagrilintide half copies a different hormone called amylin, which your pancreas releases alongside insulin whenever you eat. Amylin slows digestion and signals fullness through a separate route in the brainstem. Because the two hormones act through different pathways, combining them produces more weight loss than either one on its own. Both come in a single once-weekly shot.
How You Take It
CagriSema is not FDA approved. The only legitimate way to receive it today is through an active clinical trial. Anything sold online as "CagriSema" or "cagrilintide" outside a trial is not FDA approved, has unverified purity and dosing, and is illegal to sell or import.
How Much Weight You Can Lose
REDEFINE 1 followed 3,417 adults with obesity, or overweight plus a weight-related condition, but without type 2 diabetes, for 68 weeks. People on CagriSema lost an average of 22.7% of their body weight if they stayed on treatment, and 20.4% when everyone who started is counted. Placebo lost 2.3 to 3.0%. About 92% of people on CagriSema lost at least 5% of their body weight, against about 32% on placebo. For a 200-pound person, 22.7% is roughly 45 pounds. A second trial, REDEFINE 2, followed 1,206 adults who also had type 2 diabetes and found about 15.7% average weight loss over the same 68 weeks. Weight loss runs smaller in people with type 2 diabetes across every GLP-1 trial, so that gap is expected rather than a warning sign.
Side Effects
Common Side Effects
- Nausea (about 55% of users in REDEFINE 1, against 12.6% on placebo)
- Constipation (about 31% of users, against 11.6% on placebo)
- Vomiting (about 26% of users, against 4.1% on placebo)
- Diarrhea
- Decreased appetite (common, and part of how the drug works)
- Abdominal pain
- Fatigue
- Injection site reactions (uncommon, mild redness near the shot)
Rare but Serious
- Pancreatitis (rare)
- Gallbladder disease
- Thyroid C-cell tumors (boxed warning class effect for GLP-1 medications)
- Hypoglycemia (when combined with insulin or sulfonylureas)
- Kidney injury (from dehydration if vomiting or diarrhea is severe)
- Allergic reactions
Managing side effects: Stomach side effects were more common in the CagriSema trials than in the trials for Wegovy (nausea about 44%) or Zepbound (about 33%). That is worth knowing before you decide to wait for it. The pattern itself was familiar: worst in the first weeks and during dose increases, then easing, and most cases were mild or moderate. If CagriSema is approved, expect the same advice that applies to every drug in this class, which is to step the dose up slowly, eat smaller meals, and stay hydrated.
CagriSema Cost & Savings (2026)
Savings programs: CagriSema is not on the market, so no price has been announced. Novo Nordisk sells the Wegovy pens to cash-paying patients for $349 per month through NovoCare Pharmacy, and the Wegovy pill from $149 per month. Those are the closest guide we have to where a combination product might land, and they are a guide rather than a forecast. Clinical trial participants receive the drug at no cost.
Who Should Not Take CagriSema
- Personal or family history of medullary thyroid carcinoma (MTC) (class effect with all GLP-1 medications)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Pregnancy or planning to become pregnant
- Active pancreatitis
- Known allergy to semaglutide, cagrilintide, or any ingredient in the combination
What to Expect, Month by Month
Trial participants reported reduced hunger within the first few weeks, on the lowest step of the dose escalation.
Stepwise increase to the full cagrilintide 2.4 mg and semaglutide 2.4 mg combination. Stomach side effects were most common during this stretch.
The bulk of the weight loss in REDEFINE 1 happened during the first year on the full dose.
Average 22.7% of body weight lost in adults without diabetes, and about 15.7% in adults who also had type 2 diabetes.
Other Medications to Watch
Like every GLP-1, CagriSema combined with insulin or a sulfonylurea can push blood sugar dangerously low. Expect dose adjustments if it is approved.
CagriSema slows digestion through two separate pathways, so pills you swallow may absorb differently. Final guidance will come with the FDA label.
Special Situations
Pregnant participants were excluded from the trials. CagriSema would carry a pregnancy warning consistent with other GLP-1 medications.
Studied separately in REDEFINE 2, which enrolled 1,206 adults with type 2 diabetes and found about 15.7% average weight loss over 68 weeks. Novo Nordisk filed for weight management, not for diabetes treatment.
Adults over 65 were included in the REDEFINE trials. Detailed subgroup results have not been broken out publicly.
Not studied in adolescents. Any use in teens would need its own trials and a separate FDA decision.
What Happens If You Stop
No published trial has followed people after they stopped CagriSema. Half of the combination is semaglutide, and the STEP 1 extension found that people regained about two-thirds of the weight they had lost within a year of stopping it. There is no reason yet to expect CagriSema to behave differently.
How to make stopping easier: If it is approved, expect the same long-term logic that applies to Wegovy and Zepbound: build eating and exercise habits while the drug is doing the hard part, and plan for either long-term use or a low maintenance dose rather than a clean stop.
CagriSema FAQs
No. Novo Nordisk filed the application on December 18, 2025, and the company has said it expects a decision in the last three months of 2026. Neither the FDA nor Novo Nordisk has published a target decision date, so any specific day quoted elsewhere is someone guessing. Approval would not mean instant availability either, since supply usually takes months to reach normal pharmacies.
In REDEFINE 1, the main trial in 3,417 adults with obesity but without diabetes, people lost an average of 22.7% of their body weight over 68 weeks if they stayed on treatment, and 20.4% counting everyone who started. Placebo lost 2.3 to 3.0%. In REDEFINE 2, which enrolled adults who also had type 2 diabetes, average weight loss was about 15.7%.
No, based on the only trial that compared them directly. REDEFINE 4 put CagriSema against Zepbound in 809 adults for 84 weeks. CagriSema produced 23.0% average weight loss and Zepbound produced 25.5%. The trial was designed to show CagriSema was at least as good as Zepbound, and it did not meet that goal. Novo Nordisk reported the result in February 2026. CagriSema is still a strong drug by any normal standard. It just did not beat the best option already on the market.
Wegovy is semaglutide on its own. CagriSema is semaglutide plus a second drug, cagrilintide, which copies a different hormone called amylin. The second hormone works through its own pathway in the brain, which is why the combination produced more weight loss than semaglutide alone in trials (about 22.7% against about 15%). The trade-off is more stomach upset: 55% of people in the CagriSema trial reported nausea, against about 44% in the Wegovy trial.
Cagrilintide is a long-acting copy of amylin, a hormone your pancreas releases along with insulin whenever you eat. Amylin slows how fast your stomach empties and signals fullness through a different part of the brain than GLP-1 does. On its own it produces modest weight loss. Its value is as a partner to a GLP-1, where the two pathways add up.
For most people, no. Even if the FDA approves it late in 2026, supply usually takes months to reach normal pharmacies and insurance coverage takes longer still. Meanwhile Zepbound beat CagriSema in the one head-to-head trial that exists, and you can get it today. If you are losing weight steadily on a GLP-1 that is already available, there is no medical argument for waiting.
No, not legally. It is not approved, so no US pharmacy can fill it. Anything sold online under that name has unverified contents, no dosing standard, and no legal route into the country. Research-chemical sellers marketing peptides to consumers are not a supply chain, and we strongly advise against them.
Related CagriSema resources
Want to try CagriSema?
CagriSema is investigational. The only legitimate path to access it today is enrollment in an active clinical trial. Anything sold online is not FDA approved and may be unsafe.
Medical Disclaimer: This guide is for informational purposes only and is not medical advice. All clinical data is sourced from FDA prescribing information and published peer-reviewed trials. Individual results vary. Always consult a qualified healthcare provider before starting, stopping, or switching any medication.