CagriSema: FDA Status, Weight Loss Results, and What Comes Next
CagriSema is not FDA-approved yet. Novo Nordisk filed on December 18, 2025; the company expects FDA review in 2026, and trade press anticipates a decision by late 2026. In REDEFINE 1, weight loss was 22.7% if all stayed on treatment, 20.4% regardless of adherence.
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No — CagriSema is not approved in the United States or the European Union as of the most recent published statements [1][2]. Novo Nordisk submitted a New Drug Application (NDA) to the FDA on December 18, 2025, asking for approval of once-weekly CagriSema injection for weight reduction and long-term weight maintenance in adults with obesity, or overweight with at least one weight-related condition, when used with a reduced-calorie diet and more physical activity [1][4]. The company says the FDA is expected to review the application in 2026, and trade press reports a decision is anticipated by late 2026 [1][4][5][6]. No FDA action date has been published in any source [1][4][5][6].
On weight loss: in the pivotal REDEFINE 1 trial, adults taking CagriSema lost an average of 22.7% of body weight over 68 weeks versus 2.3% for placebo, using the trial product estimand — the estimate of what would happen if everyone stayed on treatment [1][4]. Using the treatment policy estimand, which counts everyone regardless of whether they stayed on treatment, the figure was 20.4% versus 3.0% for placebo, a statistically significant difference [1][4]. CagriSema remains investigational; its safety and efficacy are not established, and there is no guarantee it will become commercially available [2].
Is CagriSema FDA-approved yet?
Not as of the source dates. Novo Nordisk states plainly that “CagriSema is not approved in the US or EU” [1], and a later company announcement states that CagriSema is not approved in the United States [2]. The FDA submission on December 18, 2025 is a request for approval, not an approval [1][4].
The indication Novo is seeking covers adults with obesity (BMI of 30 or above), or overweight (BMI of 27 or above) with at least one weight-related comorbid condition, used alongside a reduced-calorie diet and increased physical activity for weight reduction and long-term maintenance [1]. The NDA is based on results from the REDEFINE 1 and REDEFINE 2 phase 3 trials [1][5][6].
When will the FDA decide on CagriSema?
No official FDA action date has been published in any source [1][4][5][6]. What exists instead are expectations from the company and trade coverage: Novo Nordisk says the FDA is expected to review the application in 2026 [1][4], and press reports on the REDEFINE 4 announcement say a regulatory decision is anticipated by late 2026 [5][6].
For context on how the process works, the FDA first decides whether an NDA is complete enough to accept. Once it accepts a complete application, the review team has 6 to 10 months to decide whether to approve the drug [3]. That window is a general FDA timeline, not a CagriSema-specific date.
What is CagriSema, and how is it different from Wegovy?
CagriSema is a fixed-dose combination of two medicines in one injection: cagrilintide 2.4 mg, a long-acting amylin analog, plus semaglutide 2.4 mg, a GLP-1 receptor agonist [1][4][5][6]. It is given as a once-weekly injection under the skin [1][2][6]. If approved, it would be the first injectable treatment combining a GLP-1 receptor agonist with an amylin analog [1][4].
Semaglutide alone is already marketed under several brand names: Wegovy injection 2.4 mg, Wegovy HD injection 7.2 mg, Wegovy tablets 25 mg, Ozempic injection 0.5 mg, 1 mg, or 2 mg, and Ozempic tablets 4 mg or 9 mg [2]. CagriSema takes the same kind of active ingredient as Wegovy injection and adds cagrilintide, a second mechanism. The combination is described as decreasing hunger, increasing feelings of fullness, and lowering calorie intake [5][6].
CagriSema itself is investigational. Novo Nordisk states that safety and efficacy are not established and that there is no guarantee it will become commercially available for the uses being studied [2].
How much weight did people lose in the REDEFINE 1 trial?
REDEFINE 1 was a 68-week, phase 3, randomized, double-blind trial that was both placebo-controlled and active-controlled. It enrolled 3,417 adults with obesity (BMI 30 or above) or overweight (BMI 27 or above) with at least one obesity-related complication, and without diabetes [1][4][6]. Participants received CagriSema, semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all alongside lifestyle intervention [1][4].
The headline results, all at 68 weeks [1][4]:
| Measure | CagriSema | Placebo |
|---|---|---|
| Weight loss, trial product estimand (if all stayed on treatment) | 22.7% | 2.3% |
| Weight loss, treatment policy estimand (regardless of adherence) | 20.4% | 3.0% |
| Achieved at least 5% weight reduction | 91.9% | 31.5% |
| Reached BMI below 30 (among those with obesity at baseline) | 54% | 11.1% |
Average starting body weight was about 236 lb in the CagriSema group and 235 lb in the placebo group [1][4]. The 20.4% versus 3.0% difference was statistically significant [1][4].
REDEFINE 2 ran the same kind of comparison in 1,206 adults with type 2 diabetes and either obesity or overweight, over 68 weeks versus placebo [1][4][6].
How does CagriSema compare with tirzepatide?
The only direct head-to-head data come from REDEFINE 4, announced on February 23, 2026 [5][6]. It was an open-label, randomized phase 3 trial (ClinicalTrials.gov identifier NCT06131437) that enrolled 809 adults with obesity (BMI 30 or above) and at least one comorbidity, with a mean baseline body weight of 114.2 kg, or about 251.77 lb [5][6]. Both drugs were given as once-weekly injections under the skin for 84 weeks, with tirzepatide at its 15 mg dose as the comparator [5][6].
| Estimand | CagriSema | Tirzepatide 15 mg |
|---|---|---|
| Efficacy estimand (if all adhered to treatment) | 23.0% | 25.5% |
| Treatment regimen estimand (regardless of adherence) | 20.2% | 23.6% |
The primary endpoint was the relative percent change in body weight from baseline to week 84, tested as noninferiority — whether CagriSema was at least not meaningfully worse. That threshold was not met: tirzepatide produced more weight loss on both estimands [5][6]. Novo Nordisk’s chief scientific officer, Martin Holst Lange, was quoted calling the 23% result pleasing and saying the data document that cagrilintide adds to the existing benefits of semaglutide [5][6].
Why do two different weight-loss percentages get quoted?
Because trials report results under two different statistical assumptions, called estimands. The trial product (or efficacy) estimand estimates what the weight loss would be in an idealized scenario where everyone stayed on treatment and took no other weight-loss therapy [1][5]. The treatment policy (or treatment regimen) estimand estimates the effect regardless of whether people stayed on treatment or used other therapies — closer to real-world experience [1][5].
For CagriSema, the gap matters: 22.7% versus 20.4% in REDEFINE 1, and 23.0% versus 20.2% against tirzepatide in REDEFINE 4 [1][4][5][6]. Neither number is a prediction for any individual patient; each describes a specific assumption about adherence. When reading coverage of this drug, check which estimand a figure comes from.
What are the most common side effects?
In REDEFINE 1, adverse events were mainly gastrointestinal, reported by 79.6% of the CagriSema group versus 39.9% of the placebo group [1]. The specific rates [1]:
| Side effect | CagriSema | Placebo |
|---|---|---|
| Nausea | 55% | 12.6% |
| Constipation | 30.7% | 11.6% |
| Vomiting | 26.1% | 4.1% |
Discontinuation due to adverse events was low: 5.9% with CagriSema versus 3.5% with placebo in REDEFINE 1, and 8.4% versus 3% in REDEFINE 2 [1]. Novo Nordisk states the safety data from both trials were comparable with the GLP-1 receptor agonist class [1]. In REDEFINE 4, the most common adverse events were also gastrointestinal, mostly mild to moderate and diminishing over time [5][6].
There is no FDA-approved label for CagriSema because the drug is not approved [1][2]. A full side-effect profile would come with labeling only if the FDA approves it.
What other CagriSema trials are underway?
Several REDEFINE trials are currently underway [1]. REDEFINE 3 is an event-driven cardiovascular outcomes trial comparing CagriSema with placebo in people with established cardiovascular disease, with or without type 2 diabetes, enrolling about 7,000 patients [1][6]. REDEFINE 8 runs 104 weeks with 400 patients and includes a 52-week weight-maintenance extension; REDEFINE 9 runs 68 weeks with 300 adults with obesity or overweight versus placebo; and REDEFINE 11 runs 80 weeks with 600 patients with BMI of 30 or above, with an 80-week extension phase [6][1]. Novo’s R&D leadership has also said a higher-dose CagriSema trial is planned [6].
On the type 2 diabetes side, Novo Nordisk announced on May 27, 2026 that phase 3 results from the REIMAGINE 1–3 trials across a range of type 2 diabetes background therapies will be featured in a symposium at the ADA’s 2026 Scientific Sessions in New Orleans, June 5–8, 2026, with the CagriSema symposium scheduled for Sunday, June 7 from 4:30 to 6:00 pm CDT [2]. The company says a total of 40 abstracts will be presented at the meeting, including ones on CagriSema’s effects on appetite and functional brain activity (1035-OR) and on eating control in REDEFINE 1 (1695-P) [2].
What would approval change for patients?
If approved, CagriSema would become the first injectable GLP-1 receptor agonist plus amylin analog combination [1][4]. Novo Nordisk says that if approved, it would provide patients and healthcare professionals with an additional treatment option supported by results from the REDEFINE clinical program [1][4]. Two caveats are worth holding onto.
First, no price has been announced in any source — no list price, copay figure, or self-pay cost for CagriSema exists in the published material [1][2][4][5][6]. Any dollar figure circulating before approval is not supported by these sources.
Second, on efficacy, the only direct comparison against another drug put CagriSema below tirzepatide 15 mg on both estimands in REDEFINE 4 [5][6]. The REDEFINE 1 trial also compared CagriSema with semaglutide 2.4 mg alone and cagrilintide 2.4 mg alone, but the headline percentages published in these sources are versus placebo [1][4].
Anyone weighing treatment options now should talk with a clinician about medicines that are actually approved and available, since CagriSema cannot be prescribed in the US today.
How can someone join a CagriSema study?
Study records are searchable at clinicaltrials.gov, where each trial has a registry ID [7][8]. REDEFINE 4 is registered as NCT06131437, and REDEFINE 3 as NCT05669755 [5][1]. On a study’s record, the Contacts and Locations section lists the contacts at each study site, which is the place to ask about enrollment [7][8]. Multiple REDEFINE trials are described as currently underway [1].
What else is in Novo Nordisk’s pipeline?
Novo is also developing zenagamtide, formerly known as amycretin — a single molecule that acts as both a long-acting GLP-1 and amylin receptor agonist, under investigation in both oral and subcutaneous forms [2]. Phase 2b results in type 2 diabetes are listed among the abstracts to be presented at the ADA 2026 Scientific Sessions, per the company’s May 27, 2026 announcement [2]. Like CagriSema, zenagamtide is not approved in the United States, and Novo states there is no guarantee these investigational medicines will become commercially available [2].
Sources
- Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management.
- Novo Nordisk. Novo Nordisk advances cardiometabolic pipeline with new data featuring CagriSema and zenagamtide at the American Diabetes Association’s 2026 Scientific Sessions. May 27, 2026.
- US Food and Drug Administration. Step 4: FDA Drug Review.
- Pharmaceutical Executive. Novo Nordisk Submits NDA to FDA for CagriSema. December 18, 2025.
- MPR. REDEFINE 4: CagriSema Weight Loss Results Compared With Tirzepatide.
- HCPLive. CagriSema Demonstrates Weight Loss, Fails to Achieve Primary Endpoint Compared to Tirzepatide. February 23, 2026.
- ClinicalTrials.gov. REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels (NCT05669755).
- ClinicalTrials.gov. Clinical study record NCT07607587.
- ClinicalTrials.gov. Clinical study record NCT07564414.
- ClinicalTrials.gov. A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight (NCT07253285).
- NovoCare. Wegovy (semaglutide) Cost, Coverage, & Savings Resources.
Frequently asked questions
Is CagriSema FDA-approved yet?
No. CagriSema is not approved in the US or EU as of the source dates. Novo Nordisk submitted an NDA to the FDA on December 18, 2025, seeking approval for weight management in adults with obesity or overweight plus at least one weight-related condition. The drug remains investigational, and its safety and efficacy are not established.
When will the FDA decide on CagriSema?
No official FDA action date has been published. Novo Nordisk says the FDA is expected to review the application in 2026, and trade press reports a decision is anticipated by late 2026. Under general FDA process, once an NDA is accepted as complete, the review team has 6 to 10 months to decide.
How much weight loss did CagriSema cause in its main trial?
In REDEFINE 1, adults taking CagriSema lost 22.7% of body weight at 68 weeks versus 2.3% on placebo under the trial product estimand, which assumes everyone stayed on treatment. Under the treatment policy estimand, weight loss was 20.4% versus 3.0% for placebo, a statistically significant difference.
Is CagriSema better or worse than Zepbound (tirzepatide)?
In the only direct comparison, REDEFINE 4, CagriSema did not meet its primary endpoint of noninferiority to tirzepatide 15 mg. Weight loss at 84 weeks was 23.0% for CagriSema versus 25.5% for tirzepatide under the efficacy estimand, and 20.2% versus 23.6% under the treatment regimen estimand.
Why do two different weight-loss percentages get quoted for CagriSema?
The numbers come from two statistical approaches called estimands. The trial product estimand estimates results if all patients stayed on treatment; the treatment policy estimand counts everyone regardless of adherence or other weight-loss therapy. For CagriSema in REDEFINE 1, that yields 22.7% and 20.4% respectively. Neither predicts any individual's result.
What are the most common CagriSema side effects?
In REDEFINE 1, adverse events were mainly gastrointestinal: nausea in 55% of CagriSema users versus 12.6% on placebo, constipation in 30.7% versus 11.6%, and vomiting in 26.1% versus 4.1%. Discontinuation due to adverse events was 5.9% versus 3.5% on placebo. Novo says the safety profile was comparable with the GLP-1 RA class.
Will CagriSema cost more than Wegovy?
No price for CagriSema has been announced in any source — no list price, copay card, or self-pay figure exists in the published material, and the drug is not approved. Any specific dollar figure circulating now is unsupported by the published sources.
Does CagriSema have proven heart benefits?
Not yet. REDEFINE 3, an event-driven cardiovascular outcomes trial of CagriSema versus placebo in about 7,000 patients with established cardiovascular disease, with or without type 2 diabetes, is still underway, and no results appear in these sources. The FDA filing is based on the REDEFINE 1 and 2 weight and diabetes trials.
This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.