Cagrilintide (CagriSema): research, side effects and dosage in studies

In short

Cagrilintide is a long-acting amylin analogue studied for weight management and type 2 diabetes, most often together with semaglutide under the name CagriSema. It has no marketing authorisation in the EU or the US, but several phase 3 human trials have been published [4, 5]A [30, 32]regulator.

• Given alone, cagrilintide lowered body weight by 6.0-10.8 percent in 26 weeks depending on the dose, against 3.0 percent with placebo [1]A.
• Combined with semaglutide, weight fell by 20.4 percent in 68 weeks, against 3.0 percent with placebo [4]A.
• The most common harms are gastrointestinal symptoms. In people with type 2 diabetes they were reported by 72.5 percent of those on the combination and 34.4 percent of the placebo group [5]A.
• Cagrilintide leaves the body slowly: its half-life was 159-195 hours, about 7-8 days [2]A.
• The CagriSema marketing application was filed in the US on 18 Dec 2025 [27]E, not peer-reviewed, and there was no decision on 14 Oct 2026 [30]regulator. In the EU cagrilintide was neither under evaluation nor authorised [31, 32]regulator. So there is no approved dosing.

What is cagrilintide?

Cagrilintide is a laboratory-modified version of amylin, a hormone released by the pancreas that takes part in the control of satiety. Natural amylin easily forms amyloid fibrils, which makes it a difficult starting point for drug development. Cagrilintide was designed around this problem: a fatty-acid chain was added to the molecule to lengthen its action and stabilise its structure, which makes once-weekly dosing possible. The development work was done by Novo Nordisk researchers, and the molecule was known by the code AM833 during development [11]D.

Chemically it is a peptide of 4,409 daltons with the formula C194H312N54O59S2 [24]. Cagrilintide is not a steroid or a growth hormone but a peptide, a chain of amino acids.

Cagrilintide is studied in two forms. On its own it is an amylin analogue. Together with semaglutide, as a fixed-dose combination, it is called CagriSema. Most published human trials concern the combination, not cagrilintide alone. All weight-loss drugs: Weight-loss drugs (GLP-1).

Evidence at a glance

Each cell gives the kind of study and its source. The letter is the evidence level, not the result.

"-" = no such study is known.

What is cagrilintide studied for?

Cagrilintide is studied mainly for weight management and type 2 diabetes, and also for several other uses with no published results yet. None of these is an approved use [30, 32]regulator.

The published phase 3 trials cover two things. The first is weight management in adults with obesity or overweight and at least one related condition [4]A. The second is type 2 diabetes, where both blood glucose control and body weight have been studied [5]A [6]A [7]A [23]A.

Several trials are registered but unpublished. REDEFINE 3, which looks at cardiovascular events, is under way with 7,101 participants who have established cardiovascular disease [14] [25]E, not peer-reviewed. The registry also lists a phase 2 trial on kidney damage in people with chronic kidney disease and type 2 diabetes (626 participants), a phase 2 trial on liver damage (270 participants), a phase 3 trial in children and adolescents (460 participants) and phase 1 trials on bone metabolism and muscle health [25]E, not peer-reviewed.

One registered phase 1 trial looks at how well cagrilintide is tolerated by people who cannot tolerate GLP-1 drugs [25]E, not peer-reviewed. No results have been published.

How does cagrilintide work?

Cagrilintide activates amylin receptors and, in addition, the calcitonin receptor, which sets it apart from more selective amylin analogues.

In a pharmacological comparison across 25 response measures, cagrilintide turned out to be a non-selective agonist of the amylin receptors and the calcitonin receptor [19]D. Structural studies have described how the molecule binds to both the calcitonin and the amylin receptor, and the way it binds differs from other long-acting amylin analogues [18]D [20]D.

In animal studies the site of action has been located in the brainstem. In a map of more than 530,000 cells from rats, mice and macaques, cagrilintide regulated two calcitonin-receptor neuron populations in the dorsal vagal complex of the brainstem. Long-term cagrilintide treatment increased the expression of prolactin-releasing hormone in rats, and when this expression was suppressed, the effect weakened [17]C. In another study the weight-lowering effect of cagrilintide in rats was mediated by brain amylin receptors 1 and 3 [16]C.

These findings come from animals and cells. In humans the mechanism has not been shown directly, only the outcome: changes in weight and blood glucose.

Has cagrilintide been studied in humans?

Yes, and there are unusually many human studies for an investigational peptide: phase 1, 2 and 3 trials have been published in peer-reviewed journals [1, 2, 4]A.

Cagrilintide alone

The phase 2 dose-finding trial is the most important study of cagrilintide alone. It included 706 adults who received cagrilintide 0.3-4.5 milligrams once a week, 99 adults who received liraglutide 3.0 milligrams daily and 101 adults who received placebo. Participants did not have diabetes, and their body-mass index was at least 30, or at least 27 with high blood pressure or a lipid disorder. The trial ran at 57 centres in ten countries, Finland among them. Treatment lasted 26 weeks [1]A.

Weight fell more with every cagrilintide dose than with placebo: 6.0-10.8 percent, or 6.4-11.5 kilograms, against 3.0 percent, or 3.3 kilograms, in the placebo group. The highest dose of 4.5 milligrams lowered weight more than liraglutide 3.0 milligrams, 10.8 percent against 9.0 percent, and the difference was statistically significant (p=0.03). 73 participants, 10 percent, stopped treatment permanently, most often because of adverse events (30 participants, 4 percent) [1]A.

Phase 1 trials have looked at safety in more detail. In a thorough QT study, 105 healthy participants received cagrilintide up to 4.5 milligrams or placebo. No clinically relevant prolongation of QTcF, a measure of the heart's electrical recovery, was seen: the upper limit of the two-sided 90 percent confidence interval stayed below 10 milliseconds at every time point. The sensitivity of the study was confirmed with moxifloxacin as a positive control [9]A.

The effect of kidney and liver function has been studied in two separate trials. The kidney study had 33 participants and the liver study 32, and in both the participants were split into four groups by organ function. After a single dose, total exposure and peak concentration were similar between groups with no consistent pattern [10]A.

Cagrilintide with semaglutide (CagriSema)

In a phase 1b trial, 96 otherwise healthy participants with a body-mass index of 27.0-39.9 received cagrilintide 0.16-4.5 milligrams or placebo together with semaglutide 2.4 milligrams. Doses were raised every four weeks for 16 weeks, then the target dose was continued for four weeks. Exposure rose in a straight line with the dose and did not affect the exposure to or elimination of semaglutide [2]A.

In a phase 2 trial, 92 adults with type 2 diabetes were split into three groups: the combination, semaglutide alone or cagrilintide alone, all raised to 2.4 milligrams. The trial lasted 32 weeks at 17 centres in the US. HbA1c fell by 2.2 percentage points with the combination, 1.8 with semaglutide and 0.9 with cagrilintide. The difference between the combination and cagrilintide alone was clear (-1.3 percentage points, 95 percent confidence interval -1.7 to -0.8, p<0.0001), but the difference from semaglutide alone was not statistically significant (-0.4 percentage points, -0.8 to 0.0, p=0.075). Weight fell by 15.6 percent with the combination [3]A.

The phase 3 trial REDEFINE 1 is the largest published study. It randomised 3,417 adults without diabetes: 2,108 received the combination, 302 semaglutide alone, 302 cagrilintide alone and 705 placebo, all with lifestyle advice. It lasted 68 weeks. Weight fell by 20.4 percent with the combination and 3.0 percent with placebo, an estimated difference of 17.3 percentage points (the trial's own estimate, not a straight subtraction; 95 percent confidence interval 16.6 to 18.1, p<0.001). People on the combination reached weight loss of at least 5, 20, 25 and 30 percent clearly more often [4]A.

A separate analysis of the same trial reports the blood pressure results. Systolic pressure fell in 68 weeks by 10.9 millimetres of mercury with the combination and 2.8 with placebo, diastolic by 5.4 and 1.7. The blood pressure target was reached by 63.0 percent of the combination group and 32.0 percent of the placebo group. Of the 167 participants with resistant hypertension at baseline, 42.0 percent reached the target on the combination and 29.3 percent on placebo, but this difference was not statistically certain (odds ratio 1.7, confidence interval 0.7-4.4) [13]A.

REDEFINE 2 enrolled people with type 2 diabetes: 1,206 participants from 12 countries, body-mass index at least 27 and HbA1c 7-10 percent. 904 received the combination and 302 placebo, for 68 weeks. Weight fell by 13.7 percent against 3.4 percent (estimated difference 10.4 percentage points, not a straight subtraction; confidence interval 9.5 to 11.2, p<0.001). An HbA1c of 6.5 percent or below was reached by 73.5 percent of the combination group and 15.9 percent of the placebo group [5]A.

Three other phase 3 trials in type 2 diabetes have been published. REIMAGINE 1 enrolled patients whose diabetes was not controlled by diet and exercise, at 42 centres in six countries [7]A. REIMAGINE 2 compared the combination with semaglutide alone and cagrilintide alone in 30 countries, and also tested a lower dose of 1.0 milligram of each [6]A. REIMAGINE 3 tested the combination added to basal insulin at 46 centres in six countries [23]A. In addition, the East Asian REDEFINE 5 trial compared the combination with semaglutide alone in Japan and Taiwan for 68 weeks [8]A.

In a meta-analysis of eight randomised trials and 6,898 participants, the combination lowered weight more than semaglutide alone (difference 6.60 percentage points, confidence interval 4.68 to 8.51, p<0.0001), more than cagrilintide alone (8.15 percentage points, 4.89 to 11.40) and more than placebo (14.30 percentage points, 11.19 to 17.41). Results varied a lot between trials, as the high I² values show (82-99 percent) [26]A.

Promising, but only in animal and cell studies

One finding is promising in animal studies and has not been studied in humans. Results from animal studies cannot be carried straight over to humans.

• Cagrilintide and retatrutide together no human studies

  The combination of cagrilintide and retatrutide improved weight loss and metabolic measures in obese male rats compared with either substance alone [15]C.

  If it held in humans: the combination might offer an option for people for whom current combinations are not enough.

  Why it might not translate: the study was done in rats, and only in males. Energy use and appetite control in rodents differ from those in humans, and animal doses do not translate directly into human doses. The result comes from one study and has not been repeated [15]C.

  Evidence now: one published animal study from a Novo Nordisk research group [15]C. The clinical trial registry lists no human study of the cagrilintide and retatrutide combination [25]E, not peer-reviewed.

Likewise, the weight-lowering effect of CagriSema has been described in rats: weight fell through lower energy intake while energy expenditure was maintained [15]C. This too is an animal finding.

Who studies cagrilintide?

The developer of cagrilintide and the sponsor of all registered clinical trials is the Danish company Novo Nordisk [25]E, not peer-reviewed.

The development of the molecule was published in a medicinal chemistry journal by Novo Nordisk researchers [11]D. The clinical trials were run at many centres: the phase 2 dose-finding trial in ten countries [1]A, REDEFINE 2 in twelve countries [5]A and REIMAGINE 2 in thirty countries [6]A.

Academic research also takes place without the company. Receptor pharmacology has been studied in Australia [19]D, structural biology in China [18]D [20]D, and the brainstem mechanism in an international collaboration with 31 authors [17]C. From a doping-control point of view, the substance has been studied to develop analytical methods [12]D.

Finland took part as a trial site in the phase 2 dose-finding trial [1]A.

Author of this page: editorial team

This page was written by the Molecular Recovery editorial team. The draft was made with the help of AI, and the claims were checked against the sources (AI policy). The page has not been medically reviewed. How we work: About us.

How long does cagrilintide stay in the body?

The half-life of cagrilintide in a phase 1 trial was 159-195 hours, about 7-8 days, across doses of 0.16-4.5 milligrams [2]A.

Peak concentration was reached at a median of 24-72 hours after the dose. Exposure rose in a straight line with the dose [2]A. The long half-life is why the substance is given once a week in trials, while the older amylin analogue pramlintide needs three injections a day because of its short half-life [11]D.

In practice this means it takes weeks for the substance to leave the body after the last dose. Kidney or liver impairment did not change exposure in single-dose studies [10]A.

What are the side effects of cagrilintide?

The most common harms of cagrilintide reported in trials are gastrointestinal symptoms, and they are clearly more common than with placebo [1, 4, 5]A. The same pattern is familiar from GLP-1 medicines such as semaglutide, with which cagrilintide is most often studied: side effects of peptides in studies.

What users report. In the Reddit accounts we compiled (not research), 78 of 126 people (62%) reported some harm, most often: fatigue (35, 28%), nausea (22, 17%) and food aversion or eating too little (15, 12%). People tend to post when something goes wrong, so this share does not tell how common harms are. Cagrilintide has no marketing authorisation, so most accounts are about products whose contents are unknown. 87 of 126 people (69%) used other substances at the same time, most often a GLP-1 drug: retatrutide (37), tirzepatide (36) and semaglutide (18). So the figures mostly describe combined use. The harms in detail: Cagrilintide user experiences.

Reported in humans

In the phase 2 trial, 41-63 percent of those on cagrilintide alone reported gastrointestinal adverse events depending on the dose, against 32 percent in the placebo group. The most common symptom was nausea: 20-47 percent against 18 percent. Others were constipation and diarrhoea. Injection-site reactions were also reported [1]A.

With the combination the shares are higher. In REDEFINE 1, gastrointestinal adverse events such as nausea, vomiting, diarrhoea, constipation or abdominal pain affected 79.6 percent of those on the combination and 39.9 percent of the placebo group, and they were mostly transient and mild to moderate [4]A. In REDEFINE 2 the shares were 72.5 and 34.4 percent, and most events were likewise transient and mild to moderate [5]A.

Stopping treatment because of adverse events was uncommon in the phase 2 trial: 4 percent of all participants [1]A.

Cagrilintide had no clinically relevant effect on the heart's electrical activity in a thorough QT study [9]A.

What has not been studied

No long-term effects beyond 68 weeks have been published, because the longest published trials lasted 68 weeks [4]A [5]A. The cardiovascular safety trial is still running; its first aim is to show that the combination is not worse than placebo on a composite of cardiovascular death, heart attack and stroke [14].

Interactions and who has no data

No published data are known on the use of cagrilintide during pregnancy or breastfeeding, in children or in people with cancer.

A phase 3 trial in children and adolescents is registered with 460 planned participants, but no results have been published [25]E, not peer-reviewed. No human studies on pregnancy or breastfeeding are known.

Little has been published on drug interactions. In a phase 1 trial, cagrilintide did not affect the exposure to or elimination of semaglutide [2]A. The registry lists a phase 1 trial on how CagriSema affects levels of atorvastatin and warfarin, but no results have been published [25]E, not peer-reviewed.

Kidney or liver impairment did not change single-dose pharmacokinetics, safety or tolerability [10]A. This applies to a single dose, not long-term use.

What speaks against it and what is not known

Cagrilintide on its own is clearly less effective than the combination, and the advantage of the combination over semaglutide alone is not certain on every measure [3]A.

Counter-evidence

• In the phase 2 diabetes trial, cagrilintide alone lowered HbA1c by 0.9 percentage points, while semaglutide lowered it by 1.8 [3]A. In the meta-analysis, the combination beat cagrilintide alone on weight loss by 8.15 percentage points [26]A.
• In the same phase 2 trial, the HbA1c difference between the combination and semaglutide alone was not statistically significant (p=0.075) [3]A.
• Results in the meta-analysis varied very widely between trials, with I² values of 82-99 percent [26]A. Such wide variation means the trials did not measure the same thing in the same way, so the pooled average is uncertain.
• In an animal study, artificially activating one neuron population did not affect long-term food intake or body weight in rats, even though cagrilintide changed gene expression in the same area [17]C. So the mechanism is not as simple as single findings suggest.

What the evidence does not support

• "Cagrilintide is an approved medicine": it is not. In the US the CagriSema marketing application for weight management was filed on 18 Dec 2025 [27]E, not peer-reviewed, but cagrilintide was not on the FDA's list of novel drug approvals for 2026 on 14 Oct 2026 [30]regulator. In the EU cagrilintide was not on EMA's list of new medicines under evaluation in October 2026 [31]regulator.
• Dosing recommendations: there is no approved dosing, because the product has not been approved.
• "Cagrilintide suits people who cannot tolerate GLP-1 drugs": a phase 1 trial on this is registered, but there are no results [25]E, not peer-reviewed.
• The cagrilintide and retatrutide combination in humans: there is one rat study [15]C and no human study.

What is not known

• What long-term use does. The longest published trials lasted 68 weeks [4, 5]A.
• Whether the combination affects cardiovascular events. REDEFINE 3 is still running [14] [25]E, not peer-reviewed.
• How CagriSema compares with tirzepatide. No comparative results have been published [25]E, not peer-reviewed.

Cagrilintide dosage in studies

Cagrilintide has no approved dosing, because it has not been approved as a medicine in the EU or the US [30, 32]regulator. The figures below are the doses used in trials. They are not recommendations. On reading study doses in general: dosage in studies.

What the figures do not tell you. These doses were given under controlled trial conditions, with screened participants and, in the repeated-dose trials, the dose raised step by step over several weeks. A study dose does not tell anyone what a safe dose would be for them. The highest dose studied is not the same as the best dose: in the phase 2 trial, adverse events became more common as the dose rose [1]A. Also, nearly all recent trials concern the fixed combination with semaglutide, not cagrilintide alone. A fuller table with sources: cagrilintide doses in studies. Unit converter: cagrilintide calculator.

Cagrilintide vs semaglutide: what is the difference?

Cagrilintide and semaglutide act on different receptors, and in published head-to-head comparisons semaglutide lowered blood glucose more, while the combination lowered weight more than either alone [3, 26]A.

Semaglutide is a GLP-1 receptor agonist; cagrilintide is an agonist of the amylin and calcitonin receptors [19]D. That is why they are studied together: their mechanisms differ, and the assumption is that they complement each other.

Direct comparisons come from trials in which both had their own groups. In the phase 2 diabetes trial, HbA1c fell by 1.8 percentage points with semaglutide and 0.9 with cagrilintide [3]A. REDEFINE 1 had separate groups for semaglutide alone (302 participants) and cagrilintide alone (302 participants) [4]A, and REIMAGINE 2 compared the combination with each alone [6]A. According to the meta-analysis, the combination lowered weight by 6.60 percentage points more than semaglutide alone [26]A.

Compared with the older liraglutide, the highest cagrilintide dose of 4.5 milligrams lowered weight more than liraglutide 3.0 milligrams, 10.8 percent against 9.0 percent in 26 weeks [1]A.

Cagrilintide has not been compared with retatrutide in humans. There is one rat study of the two together [15]C. The combination is being compared with tirzepatide in registered trials, but no comparative results have been published [25]E, not peer-reviewed. The drugs side by side: weight-loss drugs compared.

Combinations and blends

The studied combination of cagrilintide is a fixed-dose product with semaglutide, called CagriSema [4]A.

In trials the combination is given as one weekly injection, and a dual-chamber pen has been developed for it whose usability was studied separately [21]. All phase 3 results on this page concern this combination [4]A [5]A [6]A [7]A [8]A [23]A.

No other combinations have been studied in humans. There is one rat study of cagrilintide with retatrutide [15]C, but it has not been studied in humans and there is no registered human trial of it [25]E, not peer-reviewed. A product sold online as "CagriSema" is not the trial product. On blends in general: Peptide blends: what is in the vial and why the seller's word is not enough.

Status in the United States

The FDA had not approved cagrilintide by 14 Oct 2026. Novo Nordisk filed the CagriSema marketing application with the FDA on 18 Dec 2025 for weight management, and according to the company the FDA was expected to review it during 2026 [27]E, not peer-reviewed. So the application has been filed, but there was no decision on 14 Oct 2026: cagrilintide was not on the FDA's list of novel drug approvals for 2026 (page updated 9 Oct 2026) [30]regulator.

According to the FDA, cagrilintide cannot be used in compounding, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition [29]regulator.

Is cagrilintide legal in Finland?

Cagrilintide has no marketing authorisation in Finland or elsewhere in the EU, so it cannot legally be sold or marketed as a medicine [32]regulator.

• EU. EMA's data set of centrally assessed medicines contained no medicine with cagrilintide on 13 Oct 2026 [32]regulator, and cagrilintide was not on EMA's October 2026 list of new medicines under evaluation [31]regulator.
• Fimea's warning. In Finland, Fimea is responsible for marketing authorisations and the supervision of medicines. A product meant as a medicinal substance without a marketing authorisation may not be sold to consumers. Fimea has specifically warned against using injectable peptides bought online [22]regulator.
• "Research use only". The label "research use only" is a classification, not a permit. It says the product is not intended or made for human use, and it has not gone through the quality, safety and efficacy checks required of a medicine. The label does not make the product legal for human use [22]regulator.
• Import and travel. Overview: Peptides and the law in Finland. Bringing them back from a trip: Travelling with peptides.

This is not legal advice. Disclaimer.

Is cagrilintide a doping substance?

Cagrilintide is not named on WADA's 2026 Prohibited List, but as a substance without marketing authorisation it falls under class S0. Class S0 bans substances with no approval by any health authority for human therapeutic use, including drugs in clinical development, and it is banned at all times [28]regulator [30, 32]regulator.

Semaglutide has been on WADA's Monitoring Program since 2024 [12]D. The Monitoring Program is not a prohibited list: it gathers information on how widely a substance is used, and using a monitored substance carries no sanction.

In the research literature, amylin receptor agonists, cagrilintide included, are seen as substances whose metabolism and detection should be studied for drug testing in sport, because weight control decides results in many sports. A study published in 2026 developed and validated a mass spectrometry method to detect pramlintide, cagrilintide and KBP-066. All three broke down from both the N- and the C-terminal end, and the breakdown products contained stable targets for analysis. For cagrilintide the results were confirmed with dosing experiments in rats [12]D.

Competitive athletes should check the current lists of their sports federation and anti-doping agency, because the lists are updated every year.

How can a cagrilintide product be assessed?

For cagrilintide sold as a research chemical, you can check the certificate of analysis, the COA, but it does not tell you the same as the quality control of a medicine.

Cagrilintide is a peptide of 4,409 daltons with the molecular formula C194H312N54O59S2 and PubChem identifier 171397054 [24]. These details let a laboratory confirm the identity of the substance by mass spectrometry.

Reading a certificate of analysis has its own page: how to read a COA. Two things on a certificate are worth checking. The first is the method: a purity percentage without a method is just a number. Liquid chromatography, HPLC, tells the purity; mass spectrometry tells whether it is the right molecule. The second is the batch number: the batch number on the certificate must match the one on the vial, or the certificate does not cover that product.

On handling and storing the powder: mixing and storage. What a certificate of analysis does not tell you: sterility, endotoxin content, whether the whole batch matches, or what happened to the product during shipping and storage. The marketing authorisation process for a medicine covers these; selling a research chemical does not.

The future: what comes next?

The next cagrilintide results are expected from trials under way, the largest of which is the cardiovascular trial REDEFINE 3 [14] [25]E, not peer-reviewed.

REDEFINE 3 is a double-blind, placebo-controlled trial in people with established cardiovascular disease and a body-mass index of at least 25, with or without diabetes. Its safety aim is to show that the combination is not worse than placebo on a composite of cardiovascular death, heart attack and stroke, and its efficacy aim is to show that the combination is better than placebo [14]. According to the registry, 7,101 people take part [25]E, not peer-reviewed.

Other registered trials are phase 2 trials on kidney and liver damage, a phase 3 trial in children and adolescents, and phase 1 trials on bone metabolism, muscle health and tolerability in people who cannot tolerate GLP-1 drugs [25]E, not peer-reviewed. None of them has published results.

In the US the CagriSema marketing application has been filed [27]E, not peer-reviewed, but there was no decision on 14 Oct 2026 [30]regulator. On upcoming weight-loss drugs: upcoming weight-loss drugs. News: Peptide news.

FAQ

Read the research yourself: sources

Every source opens the original publication or the regulator's page. The level shows what the source itself reports.

1. Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021;398:2160-2172. PMID 34798060 A
2. Enebo LB, Berthelsen KK, Kankam M, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021;397:1736-1748. PMID 33894838 A
3. Frias JP, Deenadayalan S, Erichsen L, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023;402:720-730. PMID 37364590 A
4. Garvey WT, et al; REDEFINE 1 Study Group. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393:635-647. PMID 40544433 A
5. Davies MJ, et al; REDEFINE 2 Study Group. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025;393:648-659. PMID 40544432 A
6. Buse JB, et al. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. Lancet Diabetes Endocrinol. 2026;14:662-677. PMID 42251859 A
7. Aroda VR, et al. Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. Lancet Diabetes Endocrinol. 2026;14:649-661. PMID 42251860 A
8. Yamauchi T, et al. Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2026;14:450-462. PMID 42009015 A
9. Gabe MBN, et al. Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. Diabetes Obes Metab. 2024;26:5805-5811. PMID 39279639 A
10. Nielsen MJF, et al. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet. 2026;65:1087-1099. PMID 42228334 A
11. Kruse T, et al. Development of Cagrilintide, a Long-Acting Amylin Analogue. J Med Chem. 2021;64:11183-11194. PMID 34288673 D
12. Alhalabi H, et al. In vitro metabolic profiling of weight-loss-inducing amylin receptor agonists in the context of preventive doping research. J Pharm Biomed Anal. 2026;273:117418. PMID 41702251 D
13. Verma S, et al. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1. Hypertension. 2026;83:e26055. PMID 41328546 A
14. Cavender MA, et al. Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3). Am Heart J. 2026:107626. Design article, no results. PMID 42838477 (review)
15. Petersen J, et al. Cagrilintide and retatrutide combination therapy enhances weight loss and metabolic outcomes in obese male rats. Nat Metab. 2026 (online 15 Sep 2026). PMID 42744908 C
16. Carvas AO, et al. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3. EBioMedicine. 2025;118:105836. PMID 40609154 C
17. Ludwig MQ, et al. A cross-species atlas of the dorsal vagal complex reveals neural mediators of the effects of cagrilintide on energy balance. Nat Metab. 2026;8:1350-1367. PMID 42260119 C
18. Cao J, et al. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. Nat Commun. 2025;16:3389. PMID 40204768 D
19. Fletcher MM, et al. AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors: Pharmacological Comparison with Six Selective and Nonselective Agonists. J Pharmacol Exp Ther. 2021;377:417-440. PMID 33727283 D
20. Gu YM, et al. Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors. Acta Pharmacol Sin. 2026;47:162-172. PMID 40847076 D
21. Gulisano W, et al. Ease of Use, Ease of Learning, and Convenience of the CagriSema Dual-Chamber Pen: Results From a Usability Study in Adults. J Diabetes Sci Technol. 2026. Usability study. PMID 42366647 B
22. Fimea. Fimea warns: do not use injectable peptides purchased online (29 Jun 2026). Fimea regulator
23. Rosenstock J, et al. Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet. 2026;408:38-51. PMID 42251856 A
24. PubChem. Cagrilintide, CID 171397054: molecular formula C194H312N54O59S2, molecular weight 4409. Database record, read 14 Oct 2026. PubChem
25. ClinicalTrials.gov: studies with cagrilintide as an intervention (status 13-14 Oct 2026, all sponsored by Novo Nordisk). Registry records, not peer-reviewed. clinicaltrials.gov E, not peer-reviewed
26. Shao C, et al. Efficacy and Safety of CagriSema for Metabolic Outcomes: Systematic Review and Pairwise Meta-Analysis of Randomized Controlled Trials. Diabetes Metab Syndr Obes. 2026;19:616418. PMID 42763732 A
27. Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema. Company announcement, 18 Dec 2025. Not peer-reviewed, not a regulatory decision. novonordisk.com E, not peer-reviewed
28. WADA: 2026 Prohibited List, class S0 Non-Approved Substances. wada-ama.org (PDF) regulator
29. U.S. Food and Drug Administration. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 1 Oct 2026). FDA regulator
30. U.S. Food and Drug Administration. Novel Drug Approvals for 2026 (content current as of 9 Oct 2026; read 14 Oct 2026): 46 approvals, none with cagrilintide. FDA regulator
31. European Medicines Agency. Applications for new human medicines under evaluation by the CHMP, October 2026: cagrilintide not listed. EMA (Excel) regulator
32. European Medicines Agency. Medicines data, list of centrally assessed medicines (data set of 13 Oct 2026): no medicine containing cagrilintide. EMA regulator

Sources checked on 13-14 Oct 2026. The FDA and EMA pages were read on 14 Oct 2026. The REDEFINE 1 adverse-event figures are as given in the abstract of the publication.

Evidence levels: A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed · regulator = a regulator's assessment or decision, not research evidence. The marker official means official product information (summary of product characteristics or label); it is not research evidence. For a review, the level shows what kind of research the statement rests on. No level: statements that something has not been studied, reviews' interpretations, named hypotheses and the general rules in our certificate-of-analysis guide.

Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.