CagriSema: What to Know Before FDA Approval
Quick Read
CagriSema is a once-weekly injection that pairs semaglutide, the active ingredient in Wegovy, with a newer medication called cagrilintide. In clinical trials, people lost an average of about 20% to 23% of their body weight, and the FDA is expected to make an approval decision by the end of 2026. Until then, FDA-approved GLP-1 medications are available now and work well for many people.
What is CagriSema?
CagriSema is an investigational once-weekly injection for weight management that combines two medications: cagrilintide and semaglutide. It's made by Novo Nordisk, the company behind Ozempic® and Wegovy®.
Each dose contains 2.4 mg of cagrilintide and 2.4 mg of semaglutide. Semaglutide is the same active ingredient in Wegovy®, at the same dose. Cagrilintide is a newer synthetic medication that mimics a natural hormone called amylin.
Novo Nordisk has applied for FDA approval of CagriSema for adults with obesity, or overweight adults and at least one weight-related health condition, such as high blood pressure. If approved, it would be the first weekly injection to combine a GLP-1 medication with an amylin medication.
How Does CagriSema Work?
CagriSema mimics two natural hormones that help you feel full, so you feel less hungry and eat less.
Semaglutide mimics GLP-1, a hormone your gut releases after you eat. It signals your brain that you're full, slows how quickly food leaves your stomach, and helps regulate blood sugar.
CagriSema's second ingredient, cagrilintide, mimics amylin. Your pancreas releases amylin alongside insulin after meals. Amylin also tells your brain you've had enough to eat, but it works through a different pathway from GLP-1.
Using both together targets appetite from two directions at once. That combined effect is why CagriSema led to more weight loss in trials than either medication on its own.
How Much Weight Did People Lose in CagriSema Trials?
In the main clinical trial, people taking CagriSema lost an average of 22.7% of their body weight after 68 weeks, compared to 2.3% for people taking a placebo.
That trial, called REDEFINE 1, was published in The New England Journal of Medicine in 2025. It included 3,417 adults with obesity or overweight who didn't have type 2 diabetes. Researchers compared CagriSema to each of its two ingredients on its own and to a placebo.
Treatment | Average weight loss at 68 weeks |
CagriSema | 22.7% |
Semaglutide alone | 16.1% |
Cagrilintide alone | 11.8% |
Placebo | 2.3% |
These averages come from people who stayed on treatment as directed. When researchers counted everyone who enrolled, including people who stopped early or missed doses, average weight loss with CagriSema was 20.4%. The first number shows what the medication can do when taken consistently. The second gives a more real-world picture.
Some people lost much more than the average. About 40% of people on CagriSema lost 25% or more of their body weight, compared to 16.2% of people on semaglutide alone.
A second trial, REDEFINE 2, included 1,206 adults with obesity or overweight and type 2 diabetes. People taking CagriSema lost an average of 15.7% of their body weight after 68 weeks, compared to 3.1% with placebo. People with type 2 diabetes tend to lose less weight on these medications overall, so this result is in line with what's expected for that group.
How Does CagriSema Compare to Zepbound® and Wegovy® ?
Zepbound led to more weight loss than CagriSema in a head-to-head trial, while CagriSema led to more weight loss than semaglutide, the active ingredient in Wegovy®.
In the REDEFINE 4 trial, 809 adults with obesity took either CagriSema or tirzepatide, the active ingredient in Zepbound, for 84 weeks. People who stayed on treatment lost an average of 23% of their body weight on CagriSema and 25.5% on tirzepatide. The trial set out to show CagriSema was at least as effective as tirzepatide, and it didn't meet that goal.
In REDEFINE 1, CagriSema led to more weight loss than semaglutide given at the same dose used in Wegovy®.
Medication | FDA status | How it's taken | Average weight loss in CagriSema trials |
CagriSema | Under review | Once-weekly injection | 22.7% at 68 weeks (REDEFINE 1), 23% at 84 weeks (REDEFINE 4) |
Zepbound® (tirzepatide) | Approved | Once-weekly injection | 25.5% at 84 weeks (REDEFINE 4) |
Wegovy® (semaglutide) | Approved | Once-weekly injection or daily pill | 16.1% at 68 weeks (REDEFINE 1) |
Trial averages are a starting point. Side effects, cost, insurance coverage, and your other health conditions all play a role in which medication fits you best.
Foundayo® (orforglipron)
Wegovy® Pill (semaglutide)
Zepbound® (tirzepatide)
Wegovy® (semaglutide)
Saxenda® (liraglutide)
Ozempic® (semaglutide)
Mounjaro® (tirzepatide)
What are the Side Effects of CagriSema?
The most common side effects of CagriSema are digestive, including nausea, constipation, and vomiting, and most were mild to moderate and eased over time.
In REDEFINE 1, about 80% of people on CagriSema had at least one digestive side effect, compared to about 40% on placebo.
Side effect | CagriSema | Placebo |
Nausea | 55% | 12.6% |
Constipation | 30.7% | 11.6% |
Vomiting | 26.1% | 4.1% |
These side effects are similar to what people experience on other GLP-1 medications. In trials, the dose was increased gradually over several weeks to help the body adjust.
Few people stopped treatment because of side effects. In REDEFINE 1, 5.9% of people on CagriSema stopped for this reason, compared to 3.5% on placebo. In REDEFINE 2, those numbers were 8.4% and 3%.
The FDA will set CagriSema's full safety information if it's approved. Since it contains semaglutide, providers will likely review the same health history they check before prescribing Wegovy® , such as a personal or family history of certain thyroid cancers.
When Will CagriSema Be FDA Approved?
The FDA is expected to decide on CagriSema by the end of 2026. Novo Nordisk submitted its application on December 18, 2025, and confirmed a fourth-quarter 2026 decision window again in October 2026.
The FDA hasn't shared an exact decision date. When it finishes its review, there are three possible outcomes:
Approval, which means providers can prescribe CagriSema in the US
A complete response letter, which means the FDA won't approve CagriSema as submitted and explains what Novo Nordisk needs to fix before they can reapply
An extended review, which pushes the decision back
After approval, it can take a few weeks or months for a new medication to reach pharmacies and for insurance plans to decide on coverage.
Novo Nordisk is also running more CagriSema trials, including a longer study expected to report results in the first half of 2027 and a trial of a higher-dose version. CagriSema is one of several new weight loss medications in development, alongside retatrutide.
Can You Get CagriSema Now?
No, CagriSema isn't available yet, and the only way to take it before FDA approval is through a clinical trial.
Some websites sell products labeled as "compounded CagriSema" or cagrilintide. The FDA has stated that cagrilintide can't legally be used in compounded medications. These products haven't been reviewed for safety, quality, or dosing accuracy, and anyone selling CagriSema right now isn't selling the real medication.
How Much Will CagriSema Cost?
Novo Nordisk hasn't announced a price for CagriSema yet. Pricing is usually shared around the time a medication is approved.
The cost will depend on the list price, whether your insurance plan covers it, and whether Novo Nordisk offers a savings program. Coverage for weight management medications varies widely between plans, and new medications often take time to be added.
What are Your Options While You Wait for CagriSema?
You can start an FDA-approved weight management medication now and still consider CagriSema later if it's approved. Wegovy® , available as a weekly injection or a daily pill, and Zepbound® both led to significant weight loss in clinical trials and are available by prescription today.
Waiting for a new medication also means months without treatment. Starting now gives you time to build habits around eating, activity, and managing side effects, and those habits support any medication you take. Your health history, lab results, and progress records also give a provider a clear picture if you decide to try a different medication down the road.
To learn what to have ready if you change medications or providers later, read how to switch GLP-1 providers.
Get prescription weight loss medication — no injection required.
Find out if you're eligible for the Wegovy® pill, and get started on your weight loss journey. Program starting at $75/month .
How Can LifeMD Help You Start Weight Management Treatment Now?
LifeMD connects you with licensed providers who can help you find an FDA-approved weight management medication that fits your health and goals. Everything starts with an online consultation from home, so there's no waiting room or extra trip to schedule.
If a provider prescribes medication, your prescription is sent directly to your pharmacy. Ongoing follow-up visits help adjust your dose, manage side effects, and keep your progress on track.
Check your eligibility for the LifeMD Weight Management Program to get started.
The information provided is not a substitute for professional medical advice and is for informational purposes only. Availability of specific treatments and offerings varies by state. Medications prescribed if clinically appropriate based on completion of required consultation.
