CagriSema: Novo Nordisk''s 22.7% Weight Loss Drug Explained
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Understand CagriSema, a weekly injection combining cagrilintide and semaglutide, with details on its components and current status.
CagriSema is Novo Nordisk's most ambitious new obesity drug. It combines two separate hormone-targeting mechanisms in a single weekly injection, and Phase 3 data shows it significantly outperforms either component on its own.
The FDA has been reviewing the application since December 2025. As of October 2026, CagriSema is not approved in the US, EU or India and is available only in clinical trials.
What is CagriSema?
CagriSema is a fixed-dose combination injection containing:
- Cagrilintide 2.4 mg - a long-acting amylin analogue (investigational)
- Semaglutide 2.4 mg - the same GLP-1 agonist in Wegovy (already approved)
It is given as a once-weekly subcutaneous injection, the same format as Wegovy and Mounjaro.
The combination matters because amylin and GLP-1 suppress appetite through different pathways. They work on different brain regions and different receptors. Activating both at the same time produces a stronger and more complementary effect than either hormone alone.
What is amylin, and why does it matter?
Amylin is a hormone produced by the same pancreatic cells that produce insulin. It is released after meals and works alongside insulin to regulate blood sugar and appetite. Its effects include:
- Slowing gastric emptying (food stays in the stomach longer)
- Suppressing glucagon (reduces blood sugar spikes after meals)
- Signalling satiety through the hypothalamus and brainstem
A drug called pramlintide (Symlin) has existed as an amylin analogue for diabetes since 2005, but it is injected before each major meal, which many patients find impractical. Cagrilintide is a long-acting version designed specifically for once-weekly use.
What do the Phase 3 REDEFINE trials show?
Novo Nordisk ran a comprehensive Phase 3 program under the REDEFINE name.
REDEFINE 1 (Key pivotal trial - obesity without diabetes)
- 3,417 adults with obesity or overweight plus at least one comorbidity
- 68 weeks
- CagriSema: 22.7% average weight loss (people who stayed on treatment; 20.4% counting everyone)
- Semaglutide 2.4 mg alone: 16.1% (14.9%)
- Cagrilintide 2.4 mg alone: 11.8% (11.5%)
- Placebo: 2.3% (3.0%)
- This trial was a key basis for the NDA submission to the FDA
REDEFINE 2 (Obesity + type 2 diabetes)
- 1,206 adults, 68 weeks
- CagriSema: 15.7% average weight loss vs 3.1% placebo (people who stayed on treatment; 13.7% vs 3.4% counting everyone)
- 89.7% of patients on CagriSema achieved at least 5% weight loss
REDEFINE 4 (Head-to-head vs Tirzepatide 15 mg)
- 809 adults, 84 weeks, open-label comparison (results announced February 2026)
- CagriSema: 23.0% weight loss vs 25.5% with tirzepatide 15 mg (people who stayed on treatment; 20.2% vs 23.6% counting everyone)
- Did not achieve non-inferiority versus tirzepatide 15 mg. Tirzepatide performed better.
- This result matters. CagriSema is powerful, but Zepbound remains the current injectable benchmark.
High-dose CagriSema (planned)
Novo Nordisk plans a Phase 3 trial of a higher-dose formulation (cagrilintide 2.4 mg/semaglutide 7.2 mg) starting in the second half of 2026. Whether it produces stronger results is not yet known.
How does CagriSema compare to other drugs?
| Drug | Mechanism | Status | Avg. weight loss |
|---|---|---|---|
| Wegovy 2.4 mg | GLP-1 | ✅ Approved | ~15–17% |
| Zepbound 15 mg | GIP + GLP-1 | ✅ Approved | ~21% |
| CagriSema 2.4/2.4 mg | Amylin + GLP-1 | FDA review | 22.7–23% |
| Wegovy HD 7.2 mg | GLP-1 | ✅ FDA approved (March 2026) | ~21% |
Trial results are not directly comparable across different studies, and in the one head-to-head trial (REDEFINE 4) Zepbound produced more weight loss than CagriSema. And it introduces a genuinely novel mechanism, amylin plus GLP-1, not currently available in any approved drug.
What are the side effects?
Side effects in the REDEFINE trials were primarily gastrointestinal, consistent with the semaglutide component:
- Nausea
- Diarrhea
- Vomiting
- Constipation
Most were mild to moderate and diminished over time. Blood pressure and some other cardiometabolic markers also improved in the trials, but whether CagriSema reduces heart attacks or strokes has not yet been shown. Because it contains semaglutide, the same warnings would be expected to apply, including pancreatitis, gallbladder problems, dehydration, and low blood sugar when combined with insulin or sulfonylureas.
When will CagriSema be available?
The NDA was submitted to the FDA on December 18, 2025. A standard FDA review takes approximately 10–12 months, and Novo Nordisk has pointed to a decision in late 2026. As of October 2026 no approval had been announced, so check the current status before relying on this.
Final takeaway
CagriSema combines semaglutide with a new amylin analogue to produce significantly stronger weight loss than semaglutide alone. It is in FDA review following a December 2025 submission, with a decision expected in late 2026. If approved, it would be the first injectable combination of a GLP-1 receptor agonist and an amylin analogue.
Related Articles
- New GLP-1 Drugs Pipeline 2026–2027: What's Coming
- Retatrutide: The Triple Agonist Explained
- Wegovy HD (High Dose): What You Need to Know
Consult your healthcare provider before making any treatment decisions based on pipeline data.
Consult your healthcare provider before starting any medication.
Sources
- REDEFINE 1 trial record on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05567796
- Novo Nordisk announcement on CagriSema NDA submission (December 2025): https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916470
- Novo Nordisk REDEFINE 1 headline results (December 2024): https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=915082
- Novo Nordisk REDEFINE 2 headline results (March 2025): https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=915294
- Novo Nordisk REDEFINE 4 headline results (February 2026): https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916501
- FDA approval of higher-dose semaglutide (Wegovy HD), March 2026: https://www.fda.gov/news-events/press-announcements/fda-approves-fourth-product-under-national-priority-voucher-program-higher-dose-semaglutide
- REDEFINE 1 publication — PubMed: https://pubmed.ncbi.nlm.nih.gov/40544433/
- STEP 1 semaglutide trial — PubMed: https://pubmed.ncbi.nlm.nih.gov/33567185/
FAQ
What is CagriSema?
CagriSema is a once-weekly injectable combination of cagrilintide (2.4 mg, an amylin analogue) and semaglutide (2.4 mg, a GLP-1 agonist) developed by Novo Nordisk. As of October 2026 it is not yet FDA approved - an NDA was submitted in December 2025 and Novo Nordisk expects an FDA decision in 2026.
How much weight does CagriSema cause you to lose?
In the REDEFINE 1 Phase 3 trial in adults with obesity or overweight without diabetes, people who stayed on treatment lost an average of 22.7% of body weight at 68 weeks, versus 16.1% with semaglutide alone and 11.8% with cagrilintide alone. Counting everyone regardless of whether they stopped treatment, the figure was 20.4%.
What is cagrilintide?
Cagrilintide is a long-acting analogue of amylin, a hormone secreted by the pancreas alongside insulin after eating. Amylin reduces appetite, slows gastric emptying, and suppresses glucagon through different brain pathways to GLP-1. Combining both creates a stronger and more complementary appetite effect.
Is CagriSema better than Wegovy?
In the REDEFINE 1 trial, CagriSema produced 22.7% weight loss vs 16.1% for semaglutide 2.4 mg alone (among people who stayed on treatment) - a meaningful difference. In REDEFINE 4, CagriSema produced 23.0% weight loss but did not achieve non-inferiority versus tirzepatide 15 mg (Zepbound), which produced 25.5%.
When will CagriSema be available?
Novo Nordisk submitted the NDA to the FDA on December 18, 2025, and expects the FDA review to be completed in 2026. As of October 2026 no approval had been announced, and it is not approved in the EU or India. Products sold online as 'CagriSema' are not legitimate.
Written by
Masters in Microbiology
Health Content Writer
Anuja Akkar is a Masters in Microbiology professional who contributes evidence-informed health and wellness content for Weight Easy.
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Dietitian with experience in nutrition counseling, meal planning and promoting healthy lifestyles. Dedicated to help individuals achieve optimal health and well-being through personalized nutrition strategies. Skilled in providing expert guidance for managing conditions like diabetes, weight challenges and Lifestyle management.
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