In the 68-week REDEFINE 1 trial, adults without diabetes lost an average of 20.4% of body weight on CagriSema, vs 3.0% on placebo, counting everyone who started [2]. In a head-to-head trial against tirzepatide 15 mg, the drug in Zepbound, it produced less average weight loss [3].
CagriSema is an investigational once-weekly injection from Novo Nordisk that combines cagrilintide, a long-acting amylin analogue, with semaglutide, a GLP-1 receptor agonist [2].
When will CagriSema be available?
Novo Nordisk submitted a New Drug Application for CagriSema to FDA on Dec 18, 2025, based on the REDEFINE 1 and REDEFINE 2 trials [2]. On Oct 20, 2026, Novo said a decision is expected in the fourth quarter of 2026 and that CagriSema's safety and efficacy have not been established [1]. FDA has not posted a decision as of Oct 24, 2026.
Approval would not mean same-day pharmacy stock. If FDA approves it, Novo sets the launch date and price. We found no launch date or price in Novo's releases. If FDA asks questions instead, the timeline moves. FDA says it may require a company to answer questions about existing data or run more studies before approval [5]. Track every drug in our GLP-1 pipeline tracker. Other drugs in the tracker have their own pages, including Amgen's MariTide and Boehringer Ingelheim's survodutide.
CagriSema trial results
Novo reports two kinds of averages. One counts everyone who started, whether or not they kept taking the drug (Novo calls it the treatment policy or treatment-regimen estimand). The other estimates the result if everyone had stayed on treatment (the trial product or efficacy estimand), and it is always the larger number.
| Trial | Who was in it | Length | CagriSema | Comparison | Source |
|---|---|---|---|---|---|
| REDEFINE 1 | 3,417 adults with obesity or overweight and a weight-related condition, without diabetes | 68 weeks | -20.4% (everyone who started); -22.7% (if all stayed on treatment) | Placebo: -3.0%; -2.3% | [2] |
| REDEFINE 4 | 809 adults with obesity and a weight-related condition; open label | 84 weeks | -20.2% (treatment regimen); -23.0% (efficacy) | Tirzepatide 15 mg: -23.6%; -25.5% | [3] |
| REDEFINE 1, women only (post hoc) | 2,309 women | 68 weeks | -25.0% (efficacy estimand) | Placebo: -3.0%; semaglutide alone: -19.0% | [1] |
In REDEFINE 1, 91.9% of people on CagriSema lost at least 5% of body weight, vs 31.5% on placebo [2]. REDEFINE 4 missed its main goal: CagriSema was not shown to be non-inferior to tirzepatide [3]. Novo says the women-only figures come from a post hoc look at REDEFINE 1, not a separate test [1].
CagriSema side effects in the trials
Stomach side effects were common. In REDEFINE 1, 79.6% of people on CagriSema had a gastrointestinal side effect, vs 39.9% on placebo [2].
| Side effect | CagriSema | Placebo |
|---|---|---|
| Nausea | 55% | 12.6% |
| Constipation | 30.7% | 11.6% |
| Vomiting | 26.1% | 4.1% |
| Stopped because of side effects | 5.9% | 3.5% |
Trial numbers come from supervised use
People in the trials got drug made by Novo Nordisk and were checked by study doctors. If you are in a trial and have severe stomach pain that will not go away, or signs of an allergic reaction such as swelling of the face or throat or trouble breathing, contact the study team or get medical help now. In an emergency, call 911.
How CagriSema works
CagriSema pairs two drugs in one weekly shot. Semaglutide acts on the GLP-1 receptor, like Wegovy. Cagrilintide is a long-acting copy of amylin, a hormone released with insulin. Novo says the two target complementary pathways in obesity [2]. For how GLP-1 drugs act on appetite, see how GLP-1 drugs work.
Novo is also testing a higher-dose version (cagrilintide 2.4 mg with semaglutide 7.2 mg), with results expected in the first half of 2028 [6].
CagriSema vs Wegovy and Zepbound
Two phase 3 trials tested CagriSema directly against tirzepatide. In REDEFINE 4, tirzepatide 15 mg produced more average weight loss [3]. In REIMAGINE 5, in adults with type 2 diabetes, CagriSema 1.0 mg/1.0 mg averaged 12.4% vs 9.1% on tirzepatide 5 mg at 60 weeks, by the efficacy estimand [11]. The other numbers come from separate trials with different people and lengths, so they are context, not a ranking.
| CagriSema | Wegovy (semaglutide) | Zepbound (tirzepatide) | |
|---|---|---|---|
| FDA status | Filed; decision expected Q4 2026 [1] | Approved | Approved |
| Main trial | REDEFINE 1, 68 weeks [2] | STEP 1, 68 weeks [7] | SURMOUNT-1, 72 weeks [8] |
| Average weight change | -20.4% (everyone who started) [2] | -14.9% on 2.4 mg vs -2.4% placebo [7] | -20.9% on 15 mg vs -3.1% placebo [8] |
| Head to head | -20.2% vs tirzepatide's -23.6% in REDEFINE 4 [3] | Semaglutide 2.4 mg arm in REDEFINE 1: women averaged -19.0% vs -25.0% on CagriSema, post hoc [1] | -23.6% vs CagriSema's -20.2% [3] |
| Self-pay price a month | None announced | $199 to $399, NovoCare, checked Oct 17, 2026 [9] | $299 to $449, LillyDirect, checked Oct 17, 2026 [10] |
Both approved drugs can be prescribed today. See Wegovy vs Zepbound, Wegovy cost and Zepbound cost.
How to get CagriSema legally
Until FDA approves it, the only legal way is a clinical trial. Search open studies on ClinicalTrials.gov. A pharmacy cannot make it for you: FDA says cagrilintide "cannot be used in compounding under federal law" [4]. FDA also warns that products sold online as "research use only" have unknown quality and may be harmful [4]. See research-use-only GLP-1s.
If you want a GLP-1 now, approved options include Wegovy, Zepbound and two pills. Compare online GLP-1 programs.
How we check
Status and trial numbers come from Novo Nordisk's own releases and SEC filing. Legal status comes from FDA's Oct 1, 2026 statement on unapproved GLP-1s. Prices for approved drugs come from the makers' self-pay pages. When FDA acts, this page and the pipeline tracker change.
Questions people ask
When will CagriSema be available?
Not before FDA approves it. Novo Nordisk filed in December 2025 and expects an FDA decision in the fourth quarter of 2026 [1]. No launch date or price has been announced in Novo's releases.
Is CagriSema FDA approved?
No. Novo Nordisk said on Oct 20, 2026 that CagriSema is not approved in the US and that an FDA decision is expected in the fourth quarter of 2026 [1].
How much weight do people lose on CagriSema?
In REDEFINE 1, adults without diabetes lost an average of 20.4% of body weight at 68 weeks, vs 3.0% on placebo, counting everyone who started; if everyone had stayed on treatment, the figures were 22.7% and 2.3% [2]. These are averages.
Is CagriSema better than Zepbound?
Not against the top Zepbound dose. In REDEFINE 4, people lost an average of 20.2% on CagriSema vs 23.6% on tirzepatide 15 mg at 84 weeks, and CagriSema missed its goal of non-inferiority [3]. In REIMAGINE 5, in adults with type 2 diabetes, CagriSema 1.0 mg/1.0 mg averaged 12.4% vs 9.1% on tirzepatide 5 mg at 60 weeks, by the efficacy estimand [11].
What are the side effects of CagriSema?
Mostly stomach side effects. In REDEFINE 1, nausea affected 55% on CagriSema vs 12.6% on placebo, constipation 30.7% vs 11.6% and vomiting 26.1% vs 4.1%; 5.9% stopped because of side effects vs 3.5% [2].
Can I buy CagriSema online?
Not legally. It is not approved, and FDA says cagrilintide cannot be used in compounding under federal law; FDA warns that research-use-only products have unknown quality [4]. The legal route is a clinical trial.
How much will CagriSema cost?
No price has been announced in Novo Nordisk's releases. For comparison, Novo's Wegovy pens cost $199 to $399 a month self-pay through NovoCare Pharmacy, checked Oct 17, 2026 [9].
Medical review: pending. A licensed clinician has not yet reviewed this page.
Sources
11 cited
- Novo's CagriSema was associated with 25% weight loss on average for women. Novo Nordisk, Oct 20, 2026.
- Novo Nordisk files for FDA approval of CagriSema. Novo Nordisk, Dec 18, 2025.
- CagriSema REDEFINE 4 results vs tirzepatide (company announcement 13/2026). Novo Nordisk, Feb 23, 2026.
- FDA's concerns with unapproved GLP-1 drugs used for weight loss. US Food and Drug Administration, Oct 1, 2026.
- Step 4: FDA drug review. US Food and Drug Administration, Jan 4, 2018.
- Novo Nordisk Form 6-K: financial report for the first six months of 2026. Novo Nordisk (SEC filing), Aug 5, 2026.
- Once-weekly semaglutide in adults with overweight or obesity (STEP 1). New England Journal of Medicine (PubMed), Feb 10, 2021.
- Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1). New England Journal of Medicine (PubMed), Jun 4, 2022.
- Wegovy self-pay offer. Novo Nordisk (NovoCare Pharmacy), Oct 17, 2026.
- Zepbound on LillyDirect: self-pay prices. Eli Lilly and Company (LillyDirect), Oct 17, 2026.
- Novo's CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trial. Novo Nordisk, Sep 21, 2026.
This page is general information, not medical advice. Talk with a licensed clinician about your own care.