CagriSema
Amylin + GLP-1 combination
Also Cagri-Sema, Cagrilintide + semaglutide, Cagrilintide/semaglutide, NN9388
- Evidence
- AStrong human evidence
- FDA status
- In clinical trialsas of 2026-10-26
- Route
- Injection
- Studies cited
- 4 human0 animal or cell
A weekly weight-loss shot that combines two hormones. Large trials show about 20% weight loss over 68 weeks, but it is not yet approved.
Sold for
CagriSema is talked about as the next step after semaglutide: a weekly injection combining two hormones that early company statements suggested could beat tirzepatide on weight loss.
Studies say
Published phase 3 trials show roughly 20% body-weight loss over 68 weeks against 3% on placebo, which earns an A for the weight-loss use, but the head-to-head trial against tirzepatide missed its primary goal.
Why grade A. Two large phase 3 randomized placebo-controlled trials support the weight-loss use: REDEFINE 1 randomized 3,417 adults with overweight or obesity and REDEFINE 2 randomized 1,206 adults with type 2 diabetes, both over 68 weeks. A thorough QT study (105 participants) and a phase 2 trial of cagrilintide alone round out the human data. What is missing is regulatory approval and long-term outcome data beyond 68 weeks. 45102
FDA. CagriSema is not approved by the FDA for any use as of 2026-10-26. Novo Nordisk reported submitting it to the FDA for weight management, and the application is under review; no product name has been approved. 3
Written from 12 cited sources. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Weight loss
- Can a US doctor prescribe it?
- Not yet; it is still in trials.
- Properly tested in people?
- Yes, in large controlled trials of 3,417 and 1,206 people.
Evidence checklist
- Randomised controlled trial REDEFINE 1 and 2, placebo-controlledyes
- Human study over 100 people REDEFINE 1, 3,417 adultsyes
- More than one research group Trials all sponsored by Novo Nordiskno
- Clinical outcomes, not surrogate markers Weight and HbA1c, not outcomesno
- Human safety data beyond case reports Safety data from two large phase 3 trialsyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
CagriSema is a fixed combination of two injectable peptides, given together once a week. One is cagrilintide, a long-acting lab-made version of the pancreatic hormone amylin. The other is semaglutide, the GLP-1 receptor agonist sold as Ozempic and Wegovy. Novo Nordisk developed the pair as a single weight-management product. 42
It is an investigational drug. So there is no FDA label, no approved brand name and no legal way to buy it. The FDA has said that semaglutide products cannot be compounded under federal law when they are not in shortage. Products sold online as CagriSema fall outside any approval. 36
How it works
Semaglutide activates the GLP-1 receptor. This slows stomach emptying and raises insulin release when glucose is high. It also reduces appetite through receptors in the brain. 1
Cagrilintide mimics amylin, a hormone the pancreas releases with insulin after meals. Amylin signals fullness and slows gastric emptying through a separate receptor system. So adding it to a GLP-1 drug stacks two appetite signals. In a phase 2 trial, cagrilintide on its own produced dose-dependent weight loss over 26 weeks. 2
What human research shows
REDEFINE 1 enrolled 3,417 adults without diabetes. They had obesity, or overweight with a related condition. Researchers randomized them to CagriSema, either component alone, or placebo. All groups also got lifestyle counselling. At week 68, the estimated mean weight change was -20.4% with CagriSema and -3.0% with placebo. People on CagriSema were more likely to lose 5%, 20%, 25% and 30%. 4
REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and a body-mass index of 27 or more. At 68 weeks, weight fell 13.7% with CagriSema and 3.4% with placebo. Glycated hemoglobin reached 6.5% or lower in 73.5% of the CagriSema group, against 15.9% on placebo. 5
Late-2024 news coverage quoted a 22.7% figure. It came from a company announcement and assumed every participant stayed on treatment. The published treatment-policy estimate counts people who stopped. That figure is 20.4%. 94
In February 2026, Novo Nordisk reported the REDEFINE 4 head-to-head trial against tirzepatide. CagriSema did not meet its goal of showing non-inferiority on weight loss at 84 weeks. For comparison, tirzepatide alone produced up to 20.9% weight loss at 72 weeks in its own 2,539-person SURMOUNT-1 trial. 87
| Study | Model | Finding |
|---|---|---|
| REDEFINE 1 | Humans, n=3,417, randomized placebo- and active-controlled, 68 weeks | Estimated mean weight change -20.4% with CagriSema versus -3.0% with placebo in adults without diabetes. 4 |
| REDEFINE 2 | Humans, n=1,206 with type 2 diabetes, randomized placebo-controlled, 68 weeks | Weight fell 13.7% versus 3.4% on placebo, and 73.5% reached HbA1c of 6.5% or lower. 5 |
| Cagrilintide thorough QT study | Humans, n=105 healthy volunteers, randomized placebo-controlled | No clinically relevant QTc prolongation at the trial dose. 10 |
| REDEFINE 4 topline | Humans, open-label head-to-head versus tirzepatide, 84 weeks (company report) | CagriSema did not meet the non-inferiority goal against tirzepatide. 8 |
Safety
Gastrointestinal effects dominate. In REDEFINE 1, 79.6% of the CagriSema group reported nausea, vomiting, diarrhea, constipation or abdominal pain. On placebo it was 39.9%. In REDEFINE 2 the figures were 72.5% and 34.4%. Most events were brief and mild to moderate. 45
A dedicated QT study in 105 healthy volunteers looked at cagrilintide. It did not prolong cardiac repolarization to a clinically relevant degree. CagriSema contains semaglutide, so the warnings on the semaglutide label apply in principle. These include acute gallbladder disease. 1012
Loss of lean mass is a live question for all GLP-1-based drugs. A 2024 review found a wide range of reported lean-mass losses. Some studies showed about 15% or less of total weight lost. Others showed 40% to 60%. Imaging studies suggest muscle changes are in line with what weight loss and ageing would predict. The phase 3 papers have not published CagriSema-specific body-composition data. 11
Questions for your clinician
- Is CagriSema approved yet, or only available in trials?
- How does it compare with tirzepatide, given the head-to-head result?
- What do the 68-week results say about stomach side effects?
Questions people ask
What is the FDA status of CagriSema?
No. As of October 2026 it is under FDA review. Novo Nordisk disclosed the submission in its fourth-quarter 2025 report. Until the FDA decides, there is no approved product, no label and no legal prescription. 3
Is CagriSema available by prescription today?
Not legally in the United States. The drug has no approval. The FDA has stated that semaglutide and similar GLP-1 drugs cannot be compounded when the approved product is not in shortage. Anything sold online under the name is unregulated. 63
How does CagriSema differ from semaglutide alone?
It adds cagrilintide, a lab-made version of amylin that works through a separate receptor to signal fullness. In REDEFINE 1, the combination lost 20.4% of body weight at 68 weeks. The semaglutide-alone arm in the same trial served as an active comparator. 42
What was the 22.7% number in the news?
It came from a December 2024 company announcement and assumed all participants stayed on treatment. The peer-reviewed figure uses the treatment-policy approach, which includes people who stopped. That figure is 20.4%. 94
Does CagriSema cause muscle loss?
No CagriSema-specific body-composition data have been published. Across GLP-1-based drugs, a 2024 review found lean mass losses varied widely between studies. MRI-based work suggests the muscle changes track what the weight loss itself would predict. 11
Citations
- StatPearls: Glucagon-like peptide-1 receptor agonists ncbi.nlm.nih.gov
- Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 doi.org
- Novo Nordisk Q4 2025 report to the SEC: CagriSema submission sec.gov
- Garvey 2025, NEJM: coadministered cagrilintide and semaglutide (REDEFINE 1) pubmed.ncbi.nlm.nih.gov
- Davies 2025, NEJM: cagrilintide-semaglutide in type 2 diabetes (REDEFINE 2) pubmed.ncbi.nlm.nih.gov
- FDA: concerns with unapproved GLP-1 drugs used for weight loss fda.gov
- Jastreboff 2022, NEJM: tirzepatide once weekly for obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
- Novo Nordisk 6-K, February 2026: REDEFINE 4 headline results sec.gov
- Novo Nordisk 6-K, December 2024: REDEFINE 1 headline results sec.gov
- 2024, Diabetes Obes Metab: cagrilintide thorough QT study pubmed.ncbi.nlm.nih.gov
- 2024, Diabetes Obes Metab: lean body mass changes with GLP-1-based therapies pubmed.ncbi.nlm.nih.gov
- DailyMed: Wegovy (semaglutide) prescribing information dailymed.nlm.nih.gov