Cagrilintide and CagriSema: trials, side effects and approval status
Not yet medically reviewed. Fact-checked against the sources listed below on October 7, 2026.How we write and review
Last updated October 7, 2026
Cagrilintide is an investigational once-weekly amylin analogue from Novo Nordisk. CagriSema combines it with semaglutide. In the phase 3 REDEFINE 1 trial, mean weight change was -20.4% with CagriSema versus -3.0% with placebo over 68 weeks. No regulator had approved either in the sources checked on October 7, 2026, and no FDA Philippines registration record was found.
Key takeaways
- Cagrilintide is a long-acting amylin analogue, built to act like amylin, a pancreatic hormone that induces satiety. CagriSema is a fixed-dose combination of cagrilintide with semaglutide, not with tirzepatide.
- In REDEFINE 1 (3,417 adults with overweight or obesity without diabetes, 68 weeks), mean weight change was -20.4% with CagriSema versus -3.0% with placebo. Gastrointestinal side effects affected 79.6% versus 39.9%.
- In a 26-week phase 2 trial of cagrilintide alone, mean weight loss was 6.0% to 10.8% across five dose groups versus 3.0% with placebo.
- Novo Nordisk applied to the US FDA in December 2025, and Health Canada lists CagriSema as under review. Novo Nordisk says its EU pathway is pending the REDEFINE 3 heart outcome trial.
- The US FDA says cagrilintide cannot be used in compounding under US federal law, and it has found products sold as "research" cagrilintide to be unapproved new drugs.
- No FDA Philippines registration record was found for cagrilintide or CagriSema in a verification portal search on October 7, 2026, and no FDA Philippines advisory naming it was found.
What is cagrilintide?
Cagrilintide is an investigational medicine for weight management. It is a long-acting amylin analogue, which means it is built to act like amylin, a hormone made in the pancreas that induces satiety (the feeling of being full).
Novo Nordisk scientists developed it as a stable, lipidated, long-acting version of amylin. An earlier amylin analogue, pramlintide, needs three injections a day because it is cleared from the body quickly.
| Cagrilintide | |
|---|---|
| Type | Long-acting amylin analogue (amylin and calcitonin receptor agonist) |
| Developer | Novo Nordisk |
| Research codes | AM833, NN9833 |
| How it is given in trials | Once-weekly injection under the skin |
| Stage | Phase 3 trials, alone and as CagriSema |
| Approved anywhere | No, in the sources checked (October 7, 2026) |
Novo Nordisk's pipeline lists cagrilintide alone in phase 3 and CagriSema as submitted in the US.
What is CagriSema?
CagriSema is a fixed-dose combination of cagrilintide with semaglutide, given as one weekly injection. Semaglutide is a GLP-1 receptor agonist, the active ingredient in Ozempic and Wegovy. CagriSema is a separate investigational product, with the research code NN9838.
Two points cause confusion online:
- CagriSema contains semaglutide, not tirzepatide. Every CagriSema trial on this page pairs cagrilintide with semaglutide. Tirzepatide appears only as a comparator in head-to-head trials.
- CagriSema results are not cagrilintide results. Most large trials test the combination. Results for cagrilintide alone come from fewer trials and are shown separately below.
Novo Nordisk describes the two parts of CagriSema as targeting "complementary obesity-related pathways".
How is cagrilintide thought to work?
Cagrilintide is designed to copy amylin's effect on fullness, and it acts on the receptors amylin uses. What it does in people is still being studied.
- Receptors: cagrilintide activates the three amylin receptors (AMY1R, AMY2R and AMY3R) and the calcitonin receptor. Structural studies show it binds in a way similar to amylin.
- Brain signals (animal finding): in mice, cagrilintide lowered body weight and food intake, and the effect depended on amylin receptors 1 and 3 in the brain. That study was supported in part by a Novo Nordisk consortium grant.
- Long action: in a phase 1b study, cagrilintide had a half-life of 159 to 195 hours. It did not change how much semaglutide reached the blood.
In CagriSema, semaglutide adds GLP-1 receptor activity on top of cagrilintide's amylin activity.
What do the trials show?
Cagrilintide has been tested alone and as CagriSema, in people with and without type 2 diabetes. Novo Nordisk funded the published trials below. Cagrilintide and CagriSema dose amounts are not shown on this page; their trial groups are described as higher or lower dose groups. Tirzepatide doses named in the head-to-head trials are the comparator arms used, not treatment advice.
Cagrilintide alone
| Trial | Who took part | Length | Mean weight change | Comparator |
|---|---|---|---|---|
| Phase 2 dose-finding (Lancet 2021) | 706 adults without diabetes with obesity, or overweight with high blood pressure or high blood fats | 26 weeks | -6.0% to -10.8% across five dose groups | -3.0% with placebo. The highest dose group lost 10.8% versus 9.0% with daily liraglutide |
| REDEFINE 1, cagrilintide-alone group (company-reported; not in the peer-reviewed abstract) | 302 adults on cagrilintide alone | 68 weeks | -11.8% (trial product estimand) | Not given in this source |
| Phase 2 in type 2 diabetes (Lancet 2023) | Adults with type 2 diabetes on metformin, in a 92-person trial | 32 weeks | -8.1%; HbA1c -0.9 percentage points | CagriSema -15.6% and semaglutide -5.1% in the same trial |
CagriSema (cagrilintide with semaglutide)
| Trial | Who took part | Length | Main result | Comparator |
|---|---|---|---|---|
| Phase 1b (Lancet 2021) | 96 otherwise healthy adults aged 18 to 55 with a BMI of 27.0 to 39.9 | 20 weeks | -15.4% to -17.1% in the higher cagrilintide groups | -8.0% to -9.8% with semaglutide plus placebo |
| REDEFINE 1 (NEJM 2025) | 3,417 adults with obesity, or overweight with a complication, without diabetes | 68 weeks | -20.4% | -3.0% with placebo |
| REDEFINE 2 (NEJM 2025) | 1,206 adults with type 2 diabetes and a BMI of 27 or more | 68 weeks | -13.7%. HbA1c of 6.5% or less reached by 73.5% | -3.4% with placebo; 15.9% reached that HbA1c |
| REDEFINE 5 (Lancet Diabetes Endocrinol 2026) | 331 adults in Japan and Taiwan with overweight or obesity and obesity-related complications | 68 weeks | -18.4% (trial product estimand) | -11.9% with semaglutide alone |
| REIMAGINE 1 (Lancet Diabetes Endocrinol 2026) | 189 adults with type 2 diabetes not controlled by diet and exercise | 40 weeks | HbA1c -1.8 and -1.5 points; weight -13.8% and -11.8% in two dose groups | HbA1c -0.1; weight -1.4% with placebo |
| REIMAGINE 2 (Lancet Diabetes Endocrinol 2026) | 2,713 adults with type 2 diabetes in 30 countries | 68 weeks | HbA1c -1.91 points with the higher CagriSema dose | -1.75 with semaglutide at the matching dose |
| REIMAGINE 3 (Lancet 2026) | 274 adults with type 2 diabetes on basal insulin | 40 weeks | HbA1c -2.33 and -2.10 points; weight down 10% to 12% | HbA1c -0.66 with placebo |
Trials against tirzepatide. Three trials compared CagriSema with tirzepatide. Their results are company-reported, not peer reviewed in the sources checked.
| Trial | Design | Who took part | Result as reported by Novo Nordisk |
|---|---|---|---|
| REDEFINE 4 | Open-label, 84 weeks | 809 adults with obesity and at least one other condition | Weight loss 23.0% with CagriSema vs 25.5% with tirzepatide 15 mg (efficacy estimand); 20.2% vs 23.6% (treatment-regimen estimand). The trial "did not achieve its primary endpoint of demonstrating non-inferiority on weight loss for CagriSema compared to tirzepatide" |
| REIMAGINE 4 | Open-label, 68 weeks | People with type 2 diabetes on metformin, with or without an SGLT2 inhibitor | Weight loss 15.2% vs 15.8% with tirzepatide 15 mg; HbA1c down 1.9 vs 2.2 points (if all people adhered to treatment). Non-inferior for weight, but not for HbA1c |
| REIMAGINE 5 | 60 weeks | People with type 2 diabetes on metformin, an SGLT2 inhibitor or both | A lower dose of CagriSema: weight loss 12.4% vs 9.1% with tirzepatide 5 mg; HbA1c down 1.71% vs 1.67%. The comparator was a lower tirzepatide dose |
Body composition. In a body scan (DXA) subgroup of REDEFINE 1, Novo Nordisk reports that total fat mass fell 35.7% and lean soft tissue fell 14.4% with CagriSema by week 68. It says fat made up 67% of the weight lost. These figures are company-reported, not peer reviewed in the sources checked.
Heart outcomes. REDEFINE 3 is testing CagriSema against placebo in 7,076 adults with established cardiovascular disease and a BMI of 25 or more, at 575 sites in 24 countries. It looks at heart death, heart attack and stroke. No results have been published; Novo Nordisk expects them in the second half of 2027.
How to read these numbers. Trials reported results using different estimands (efficacy, trial product, treatment-policy or treatment-regimen), and enrolled different people for different lengths of time, so figures from different trials cannot be compared directly. Trial averages do not predict how any one person will respond.
What side effects were reported?
Stomach and gut side effects were the most common, both for cagrilintide alone and for CagriSema. In REDEFINE 1 and REDEFINE 2 they were mostly transient and mild to moderate.
| Side effect | Cagrilintide alone | CagriSema |
|---|---|---|
| Any gastrointestinal side effect | 41% to 63% vs 32% with placebo (phase 2); 54.6% vs 40.7% (REDEFINE 1, company-reported) | 79.6% vs 39.9% with placebo (REDEFINE 1); 72.5% vs 34.4% (REDEFINE 2) |
| Nausea | 20% to 47% vs 18% (phase 2); 23.8% vs 13.2% (REDEFINE 1, company-reported) | 55% vs 12.6% (REDEFINE 1, as reported by Novo Nordisk) |
| Constipation | 20.9% vs 12.3% (REDEFINE 1, company-reported) | 30.7% vs 11.6% (REDEFINE 1, as reported by Novo Nordisk) |
| Vomiting | 7.0% vs 4.4% (REDEFINE 1, company-reported) | 26.1% vs 4.1% (REDEFINE 1, as reported by Novo Nordisk) |
| Diarrhoea | 15.6% vs 12.9% (REDEFINE 1, company-reported) | Not recorded here |
| Stopped because of side effects | 1.3% stopped because of gastrointestinal side effects (REDEFINE 1, company-reported) | 5.9% vs 3.5% (REDEFINE 1) and 8.4% vs 3% (REDEFINE 2), as reported by Novo Nordisk |
Figures marked company-reported or as reported by Novo Nordisk come from Novo Nordisk releases and presentations, not from the peer-reviewed abstracts checked. "Not recorded here" means the fact file behind this page does not record the figure, not that the side effect does not occur.
Other findings:
- Injection sites: with cagrilintide alone, administration-site reactions were among the most frequent side effects in the phase 2 trial.
- Heart rhythm: in a study of 105 healthy people, cagrilintide did not cause clinically relevant QT prolongation (a change on the heart tracing) compared with placebo.
- Kidney and liver: in two small single-dose studies (33 and 32 people), kidney or liver impairment did not meaningfully change cagrilintide levels, and no serious side effects were reported. The authors note the small sizes.
- Low blood sugar: no level 2 or 3 hypoglycaemia was reported in the phase 2 diabetes trial, and no severe hypoglycaemia in REIMAGINE 3.
- Deaths: one death in REIMAGINE 3 (cancer) and one in the semaglutide group of REDEFINE 5 were judged not related to treatment.
Because it has no approved label, there is no official list of warnings, people who should not use it, or drug interactions.
Is cagrilintide or CagriSema approved?
No. No regulator had approved cagrilintide or CagriSema in the sources checked on October 7, 2026.
| Regulator | Status |
|---|---|
| US FDA | Novo Nordisk submitted a New Drug Application for CagriSema for chronic weight management on December 18, 2025. Novo Nordisk said on September 30, 2026 that it expects a decision in the fourth quarter of 2026. As of October 1, 2026, the US FDA says cagrilintide is not a component of any FDA-approved drug |
| Health Canada | Its list of new drug submissions under review includes cagrilintide with semaglutide from Novo Nordisk Canada, as a new active substance accepted in March 2026 (page modified September 24, 2026) |
| European Union | Novo Nordisk states the "Regulatory pathway for CagriSema T2D and obesity in EU pending REDEFINE 3", with REDEFINE 3 results expected in the second half of 2027. It expects a type 2 diabetes submission in late 2027 |
| FDA Philippines | No registration record found (see below) |
| Other regulators (UK, Japan, Australia, China) | Not checked on their own websites |
A submission is a request for review, not an approval. On December 18, 2025, Novo Nordisk said "CagriSema is not approved in the US or EU."
What does the US FDA say about "research" or compounded cagrilintide?
The US FDA says cagrilintide cannot legally be used to make compounded medicines in the US, and in two warning letters it found cagrilintide sold online as "research" chemicals to be unapproved new drugs.
- Compounding: as of October 1, 2026, the US FDA says: "Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition."
- Not on the compounding nominations list: cagrilintide does not appear on the US FDA list of bulk drug substances nominated for compounding under section 503A (list updated May 14, 2026).
- December 2024 warning letter: the US FDA told an online seller that its "Cagrilintide" product was an unapproved new drug. Labels such as "RESEARCH USE ONLY" did not change this, because the seller's websites showed the product was intended for human use.
- March 2026 warning letter: the US FDA again found that a cagrilintide product sold "for laboratory research purposes only" and "not for human consumption" was an unapproved new drug, because website claims about weight loss showed it was meant for people. The FDA said injectable products like these "can pose risks of serious harm to users".
No regulator or peer-reviewed report testing the quality or contents of "research" cagrilintide products was found. The FDA letters describe marketing and legal status, not lab test results.
Is cagrilintide banned in sport?
Cagrilintide is not named on the WADA Prohibited List for 2026 or 2027. It may still be prohibited under class S0, non-approved substances, which is "prohibited at all times".
- What S0 covers: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs...)". The 2027 list, in force from January 1, 2027, adds "peptides" to these examples.
- WADA's warning: its 2027 explanatory note says "Even if a peptide is not specifically named on the List, utmost caution should be taken as it may still be prohibited and may be harmful to health."
- USADA: S0 includes "drugs under pre-clinical or clinical development". Semaglutide and tirzepatide are in the WADA 2027 Monitoring Program, which means they are not prohibited but labs test for them. Cagrilintide is not listed in that program.
- Testing: in 2026, anti-doping researchers validated a lab method to detect cagrilintide and other amylin receptor agonists, citing concern about misuse in sports where weight matters.
Whether cagrilintide falls under S0 is a reading of the S0 definition, not a named listing. Athletes should check with their national anti-doping organisation.
Legal status in the Philippines
No FDA Philippines registration record was found for cagrilintide or CagriSema. On October 7, 2026, the FDA Philippines verification portal returned "No Record Found" for both names. A control search for semaglutide in the same session returned records, so the portal was working.
What this means and does not mean:
- No approval anywhere. No regulator had approved cagrilintide or CagriSema in the sources checked.
- Semaglutide alone is a different product. Ozempic and Wegovy (semaglutide) are listed as registered prescription drugs in the FDA Philippines Verification Portal (checked October 7, 2026). That does not cover CagriSema, which also contains cagrilintide.
- The law on unregistered products. The Philippine FDA Act (RA 9711) prohibits the sale, distribution, promotion or advertising of any health product that requires registration but is not registered with FDA Philippines.
- No legal route found. No Philippine source on a prescription classification for cagrilintide, or on any legal way to obtain it here, was found.
This page does not call cagrilintide "unregistered", because FDA Philippines has issued no statement about cagrilintide itself. A search that finds no record is not such a statement. To check any product, search the FDA Philippines verification portal at verification.fda.gov.ph. For how Philippine rules treat peptides in general, see are peptides legal in the Philippines.
FDA advisory history
No FDA Philippines advisory naming cagrilintide or CagriSema was found. On October 7, 2026, searches of the FDA Philippines website for "cagrilintide", "cagrisema", "cagri" and "amylin" returned no results.
A missing advisory does not mean a product is registered or approved. FDA Philippines has issued advisories on other unregistered weight-loss injectables, such as two retatrutide products in September 2026.
What to ask a doctor
If you are reading about cagrilintide or CagriSema, a licensed doctor can help you look at your options. Questions you could bring:
- Which approved weight or diabetes medicines are registered in the Philippines, and would any suit me?
- What do the trials of approved medicines show, and how do they compare with what is known about CagriSema?
- What should I watch for if I have already used an unapproved injectable peptide?
- If I compete in sport, how does the WADA Prohibited List affect what I can take?
- How can I check whether a product is registered with FDA Philippines?
For background on the approved medicines in this group, see GLP-1 medicines explained and semaglutide.
Frequently asked questions
What is cagrilintide?
Cagrilintide is an investigational, long-acting amylin analogue developed by Novo Nordisk scientists. Natural amylin is a pancreatic hormone that induces satiety. In trials, cagrilintide is given as a once-weekly injection under the skin, alone or combined with semaglutide.
What is CagriSema?
CagriSema is a fixed-dose combination of cagrilintide with semaglutide, a GLP-1 receptor agonist. It is a separate investigational product (research code NN9838). It does not contain tirzepatide.
Is CagriSema approved?
No approval was found as of October 7, 2026. Novo Nordisk submitted a New Drug Application to the US FDA on December 18, 2025 and said then that "CagriSema is not approved in the US or EU." A submission is a request for review, not an approval.
When could CagriSema be approved?
In a September 30, 2026 release, Novo Nordisk said it had applied to the US FDA and Health Canada in December 2025 and expected a decision in the fourth quarter of 2026. For the EU, Novo Nordisk says its pathway is pending the REDEFINE 3 heart outcome trial, which it expects to read out in the second half of 2027.
Is cagrilintide approved or available in the Philippines?
No FDA Philippines registration record was found for cagrilintide or CagriSema in a verification portal search on October 7, 2026, and no regulator anywhere has approved it in the sources checked. No legal route to obtain it in the Philippines was found.
How much weight did people lose with CagriSema?
In REDEFINE 1, adults with overweight or obesity and without diabetes had a mean weight change of -20.4% with CagriSema versus -3.0% with placebo over 68 weeks. In REDEFINE 2, in adults with type 2 diabetes, it was -13.7% versus -3.4%. These are trial averages and do not predict how any one person will respond.
How much weight did people lose with cagrilintide alone?
In a 26-week phase 2 trial in 706 adults, mean weight loss was 6.0% to 10.8% across five cagrilintide dose groups versus 3.0% with placebo. Novo Nordisk reports 11.8% at 68 weeks for the cagrilintide-alone group of REDEFINE 1; this figure is company-reported and not in the peer-reviewed abstract.
What are the side effects of cagrilintide and CagriSema?
Gastrointestinal side effects were the most common in trials, mainly nausea, constipation, diarrhoea and vomiting, and most were mild to moderate. In REDEFINE 1 they affected 79.6% of people on CagriSema versus 39.9% on placebo. With cagrilintide alone, injection-site reactions were also among the most frequent side effects in its phase 2 trial.
How does CagriSema compare with tirzepatide?
Three company-reported head-to-head trials, not peer reviewed in the sources checked, compared CagriSema with tirzepatide. In REDEFINE 4, CagriSema did not meet its goal of showing non-inferior weight loss versus tirzepatide 15 mg. In REIMAGINE 5, Novo Nordisk reported more weight loss with a lower dose of CagriSema than with tirzepatide 5 mg. No trial of cagrilintide alone against tirzepatide was found in the sources checked.
Is "research use only" cagrilintide legal?
The US FDA found in 2024 and 2026 that cagrilintide products sold online as "research" chemicals were unapproved new drugs, because the sellers' websites showed they were meant for human use. The US FDA also says cagrilintide cannot be used in compounding under US federal law.
Is cagrilintide banned in sport?
It is not named on the WADA Prohibited List, but it may be prohibited under class S0, which covers substances with no approval by any government health authority for human use, such as drugs in clinical development. Athletes should check with their anti-doping organisation.
Sources
- Lau et al., cagrilintide phase 2 dose-finding trial, Lancet, 2021 (PMID 34798060)
- Development of cagrilintide as a long-acting amylin analogue (PMID 34288673)
- Structural study of cagrilintide at amylin and calcitonin receptors (PMID 40204768)
- Mouse study of cagrilintide and brain amylin receptors (PMID 40609154)
- Enebo et al., cagrilintide with semaglutide phase 1b trial, Lancet, 2021 (PMID 33894838)
- Frias et al., CagriSema phase 2 trial in type 2 diabetes, Lancet, 2023 (PMID 37364590)
- Garvey et al., REDEFINE 1, New England Journal of Medicine, 2025 (PMID 40544433)
- Davies et al., REDEFINE 2, New England Journal of Medicine, 2025 (PMID 40544432)
- Yamauchi et al., REDEFINE 5, Lancet Diabetes and Endocrinology, 2026 (PMID 42009015)
- Cavender et al., REDEFINE 3 trial design, American Heart Journal, 2026 (PMID 42838477)
- Aroda et al., REIMAGINE 1, Lancet Diabetes and Endocrinology, 2026 (PMID 42251860)
- Buse et al., REIMAGINE 2, Lancet Diabetes and Endocrinology, 2026 (PMID 42251859)
- Rosenstock et al., REIMAGINE 3, Lancet, 2026 (PMID 42251856)
- Thorough QT study of cagrilintide (PMID 39279639)
- Cagrilintide in kidney and liver impairment (PMID 42228334)
- Novo Nordisk, CagriSema submitted to the US FDA, December 18, 2025
- Novo Nordisk, REDEFINE 4 headline results, February 23, 2026
- Novo Nordisk, Q2 2026 investor presentation
- Novo Nordisk, Q2 2026 financial report filed with the US SEC, August 4, 2026
- Novo Nordisk press release, REIMAGINE 5 topline results, September 21, 2026
- Novo Nordisk press release, CagriSema at EASD 2026, September 30, 2026
- Health Canada, new drug submissions under review (modified September 24, 2026)
- US FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (current as of October 1, 2026)
- US FDA, bulk drug substances nominated for use in compounding under section 503A (updated May 14, 2026)
- WADA, 2026 Prohibited List
- WADA, 2027 Prohibited List
- WADA, 2027 Prohibited List explanatory note
- USADA, athlete advisory on the 2027 Prohibited List
- Alhalabi et al., detection of amylin receptor agonists for doping control, J Pharm Biomed Anal, 2026 (PMID 41702251)
- FDA Philippines, verification portal search for cagrilintide (October 7, 2026)
- FDA Philippines, verification portal search for CagriSema (October 7, 2026)
- FDA Philippines, site search for cagrilintide (opened October 7, 2026)
- FDA Philippines, site search for CagriSema (opened October 7, 2026)
- Food and Drug Administration Act of 2009 (RA 9711), Lawphil
- FDA Philippines Verification Portal, search for Ozempic, October 7, 2026
- FDA Philippines Verification Portal, search for Wegovy, October 7, 2026
Related reading
This content is for education only and is not medical advice. Talk to a licensed doctor before starting any treatment.