Quick answer: CagriSema is Novo Nordisk’s once-weekly injection combining cagrilintide 2.4 mg (an amylin analog) with semaglutide 2.4 mg.[1] In the 68-week REDEFINE 1 trial it produced 20.4% average weight loss versus 3.0% on placebo, but it lost a head-to-head trial against tirzepatide.[1][3] It was submitted to FDA in December 2025 with a decision expected by late 2026, and it was not FDA-approved as of our mid-October 2026 review.[3]
This guide covers how CagriSema works, every major trial, side effects, how it compares with Zepbound and Wegovy, and where it stands with FDA. For the amylin component on its own, see our cagrilintide profile.
What is CagriSema?
CagriSema pairs two hormones that reduce appetite in different ways:
- Semaglutide is a GLP-1 receptor agonist, the drug in Wegovy and Ozempic. See our semaglutide profile.
- Cagrilintide is a long-acting analog of amylin, a 37-amino-acid hormone made by the same pancreatic cells that make insulin. Amylin helps regulate blood sugar and energy balance, acting mainly on appetite-related areas of the brain. An older, shorter-acting amylin drug, pramlintide, is used for diabetes.[11]
Both are given together as a single weekly injection under the skin, with the dose raised gradually to 2.4 mg of each.[1][4]
CagriSema results: weight loss
| Trial | Who | Weeks | CagriSema | Comparison |
|---|---|---|---|---|
| REDEFINE 1 | 3,417 adults with obesity, no diabetes | 68 | −20.4% | Placebo −3.0% |
| REDEFINE 2 | 1,206 adults with obesity and type 2 diabetes | 68 | −13.7% | Placebo −3.4% |
| REDEFINE 4 | Adults with obesity | 84 | −20.2% | Tirzepatide 15 mg −23.6% |
| REDEFINE 5 | 331 adults in Japan and Taiwan | 68 | −18.4% | Semaglutide 2.4 mg −11.9% |
Sources: REDEFINE 1,[1] REDEFINE 2,[2] REDEFINE 4 company report[3] and REDEFINE 5.[6]
REDEFINE 1: the main obesity trial
REDEFINE 1 randomized participants to CagriSema, semaglutide alone, cagrilintide alone or placebo.[1] Counting everyone regardless of whether they kept taking the drug, weight fell 20.4% on CagriSema, 14.9% on semaglutide, 11.5% on cagrilintide and 3.0% on placebo.[4] Among people who stayed on treatment, CagriSema produced 22.7%, and 40.4% lost at least 25% of their body weight.[4]
One caveat: the trial let people stay on lower doses, and only about 57% of the CagriSema group were on the highest dose at the end.[4]
REDEFINE 2: people with type 2 diabetes
Weight loss was smaller in people with type 2 diabetes, as with other GLP-1 drugs: 13.7% versus 3.4% on placebo. Blood sugar improved too, with 73.5% reaching an HbA1c of 6.5% or lower, versus 15.9% on placebo.[2]
CagriSema vs tirzepatide (Zepbound)
REDEFINE 4 compared CagriSema directly with tirzepatide 15 mg over 84 weeks in an open-label trial.[3]
- Counting everyone: 20.2% weight loss on CagriSema versus 23.6% on tirzepatide.
- Among people who stayed on treatment: 23.0% versus 25.5%.
- CagriSema did not meet the trial’s main goal of showing it was at least as effective as tirzepatide (non-inferiority).
In people with type 2 diabetes, the REIMAGINE 4 trial found CagriSema matched tirzepatide 15 mg on weight loss but not on lowering HbA1c.[5] For a fuller comparison, see CagriSema vs Zepbound and our tirzepatide profile.
CagriSema for type 2 diabetes
Novo Nordisk is also testing CagriSema for blood sugar control (the REIMAGINE program).
- Phase 2: in a 32-week trial of 92 adults with type 2 diabetes, HbA1c fell 2.2 points on CagriSema, 1.8 on semaglutide and 0.9 on cagrilintide; the gap versus semaglutide alone was not statistically significant. Weight fell 15.6%, 5.1% and 8.1%, and no clinically significant or severe low blood sugar was reported.[10]
- REIMAGINE 2: in 2,713 people on metformin, CagriSema 2.4 mg/2.4 mg lowered HbA1c by 1.91 points versus 1.75 on semaglutide 2.4 mg alone over 68 weeks.[7]
CagriSema side effects
As with other GLP-1 drugs, the main side effects are digestive.
- REDEFINE 1: gastrointestinal side effects, including nausea, vomiting, diarrhea, constipation and stomach pain, affected 79.6% on CagriSema versus 39.9% on placebo. Most were temporary and mild to moderate.[1]
- REDEFINE 2: 72.5% versus 34.4%.[2]
- REDEFINE 5: stomach side effects were similar to semaglutide alone (53% versus 51%).[6]
- REIMAGINE 2: adverse events of any kind were reported by 86.9% on CagriSema versus 81.2% on semaglutide 2.4 mg, most often digestive.[7]
For practical tips on these effects, see GLP-1 nausea and GLP-1 side effects.
Long-term heart safety is still being tested in REDEFINE 3, which randomized 7,076 adults with established heart disease to CagriSema or placebo.[8]
CagriSema FDA status and what’s next
- FDA submission: Novo Nordisk submitted CagriSema for weight management in December 2025, based on REDEFINE 1 and 2, and said an FDA decision was anticipated by late 2026.[3]
- Status now: it was still listed as awaiting a US decision in Novo Nordisk’s August 2026 half-year report.[5] We found no FDA approval for it in Drugs@FDA or DailyMed as of mid-October 2026.
- Lower doses: the REDEFINE 9 trial of CagriSema 1.0 mg/1.0 mg and 1.7 mg/1.7 mg beat placebo, with full results due at a conference later in 2026.[5]
- Higher dose: a phase 3 trial of cagrilintide 2.4 mg with semaglutide 7.2 mg started in 2026 and is expected to report in the first half of 2028.[5]
- REDEFINE 11, testing the standard dose’s full potential, is expected to report in the first half of 2027.[3]
If FDA approves CagriSema, the label will set the official doses and warnings. Until then, the trial numbers above are the best guide.
Can you get CagriSema now?
Only in a clinical trial. FDA states that cagrilintide cannot be used in compounding under federal law and has not been found safe and effective for any condition.[9] Products sold online as cagrilintide or “CagriSema” are unapproved and of unknown quality.
Approved options today include semaglutide (Wegovy) and tirzepatide (Zepbound). See GLP-1 drugs compared, semaglutide weight loss results and the GLP-1 drugs hub.
Questions to ask your clinician
- Am I a candidate for an approved GLP-1 medicine now, rather than waiting for CagriSema?
- Is there a CagriSema clinical trial near me?
- If CagriSema is approved, how might it compare with what I am taking?
- How would we manage stomach side effects during dose increases?
