FOR RESEARCH USE ONLY. NOT FOR HUMAN OR VETERINARY USE. NOT FOR HUMAN CONSUMPTION.
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Cagrilintide is a synthetic, lipidated analogue of amylin, a hormone released together with insulin. Five publications are reviewed here: three laboratory studies of its receptor pharmacology and receptor-bound structures, one randomised phase 2 study reported arm by arm, and one healthy-volunteer study of a single cardiac safety question, the QT interval. Studies of its co-formulation with semaglutide are excluded as a different material, and each human figure comes from material prepared for a controlled study.
Cagrilintide is a synthetic, lipidated analogue of amylin, a hormone co-secreted with insulin.
The publications on this page are of three kinds. Two are laboratory studies: one profiles which receptors cagrilintide acts at, and one determines its structure bound to each of them. One is a randomised phase 2 study in adults without diabetes, reported at 26 weeks. And one is a study in healthy volunteers that asked a single safety question — whether cagrilintide lengthens the heart's QT interval.
Much of the recent human literature gave cagrilintide together with semaglutide. Those studies are of a combination, which is a different material, and their figures are not recorded here.
This page collects what these publications report, arm by arm, with each figure printed as the publication printed it. It makes no statement about what any of it means for a person.
Mechanism under investigation
Cagrilintide
Agonist
→
Amylin receptors (AMY1R, AMY2R, AMY3R)
Calcitonin receptor (CTR)
Described by two laboratory publications as a nonselective agonist at the amylin receptors — each a pairing of the calcitonin receptor with a receptor activity-modifying protein — and at the calcitonin receptor itself, and imaged bound to all four. The human studies recorded here measured endpoints and one safety question, not mechanism.
Scope of the published work
Areas investigated
Receptor pharmacology
Receptor structural biology
Body weight
Tolerability
Cardiac repolarisation (QT interval)
Models used
In-vitro receptor pharmacology
Receptor structures
Randomised human studies
Every human figure on this page was recorded in a controlled study, under supervision, using material prepared for that study, in a population selected by its entry criteria. It is not the research material PepGenex supplies and no result here transfers to it.
Limitations
Evidence represented on this page: in vitro and human. No animal research is represented. The page reviews 5 published studies, and each figure is reported for the study that published it; results are not pooled across studies.
Common questions
What is Cagrilintide?
Cagrilintide is a synthetic, lipidated analogue of amylin, a hormone co-secreted with insulin.
How does Cagrilintide work, according to the published research?
Described by two laboratory publications as a nonselective agonist at the amylin receptors — each a pairing of the calcitonin receptor with a receptor activity-modifying protein — and at the calcitonin receptor itself, and imaged bound to all four. The human studies recorded here measured endpoints and one safety question, not mechanism.
Determined structures of cagrilintide bound to each of the three amylin receptors (AMY1R, AMY2R and AMY3R) and to the calcitonin receptor, each in an active, Gs-coupled state. (Cao et al., 2025, PMID 40204768)
Reports the development of cagrilintide, which the authors describe as a stable, lipidated, long-acting amylin analogue, and the structure-activity work that led to its selection for clinical development. The authors identify natural amylin's strong tendency to form amyloid fibrils as the central difficulty in designing an analogue of it. (Kruse et al., 2021, PMID 34288673)
Profiled AM833 (cagrilintide) across 25 pharmacological measures of receptor binding, activation and regulation, and describes it as a nonselective agonist at the amylin receptors — heterodimers of the calcitonin receptor with receptor activity-modifying proteins — and at the calcitonin receptor. (Fletcher et al., 2021, PMID 33727283)
What has published research on Cagrilintide found, and what are its limits?
This page records 5 publications, reporting laboratory (in vitro) work in 3, human work in 2. Each is listed with its identifier under References.
Human studies represented: Gabe et al., 2024, PMID 39279639; Lau et al., 2021, PMID 34798060.
Evidence represented on this page: in vitro and human.
No animal research is represented.
The page reviews 5 published studies, and each figure is reported for the study that published it; results are not pooled across studies.
Every human figure on this page was recorded in a controlled study, under supervision, using material prepared for that study, in a population selected by its entry criteria. It is not the research material PepGenex supplies and no result here transfers to it.
Is Cagrilintide approved by the U.S. FDA?
This page cites no FDA approval record for Cagrilintide; PepGenex Science states a U.S. regulatory status only where a sourced record exists.
PepGenex research materials are not FDA approved and are not for human or veterinary use.
What risks have published studies of Cagrilintide reported?
2 published human studies on this page report adverse events or safety measurements. Each is listed with its publication in the adverse-events section of this page.
Trial events do not establish a complete safety profile.
What adverse events have been reported in published studies of Cagrilintide?
Adverse events and safety measurements as reported by the published human studies on this page. Each entry is attributed to its publication.
Gabe et al., 2024, PMID 39279639
Design and population
Double-blind, randomised, placebo-controlled thorough QT study in healthy participants. Cagrilintide was given at escalating doses over the study period. To test that the assay could detect prolongation, the placebo arms also received a single dose of moxifloxacin as a positive control, in a nested crossover. 105 participants: 53 received cagrilintide and 52 placebo.
Events reported
The primary endpoint was the time-matched change from baseline in heart-rate-corrected QT interval (Fridericia, QTcF) at 12, 24, 48 and 72 hours after the last dose. At all four measurement points, the upper limit of the two-sided 90% confidence interval for the placebo-adjusted change was below 10 ms, the threshold the study set for concluding there was no clinically relevant prolongation. Moxifloxacin demonstrated the assay's sensitivity.
Lau et al., 2021, PMID 34798060
Design and population
Multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial at 57 sites in ten countries. Participants were assigned to one of five cagrilintide arms, to liraglutide, or to placebo, for 26 weeks, followed by 6 weeks without the study product. Masking covered active versus placebo, not the different active arms. 706 participants were assigned to cagrilintide (100 to 102 per arm), 99 to liraglutide and 101 to placebo, between March and August 2019.
Events reported
73 participants (10%) stopped the study product permanently, at similar rates across groups, mostly because of adverse events (30; 4%). 29 participants (4%) withdrew from the trial. The most frequent adverse events were gastrointestinal disorders — for example nausea, constipation and diarrhoea — and reactions at the site where each dose was given. Gastrointestinal adverse events were reported in 41% to 63% of participants across the cagrilintide arms, against 32% with placebo; nausea in 20% to 47%, against 18%.
Trial events do not establish a complete safety profile.
Published research
Grouped by the kind of study. Select one to narrow what is shown below.
Laboratory (in vitro)(3)
Laboratory (in vitro)
Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors.
Cao J, Belousoff MJ, Johnson RM, et al., Nature Communications, 2025;16(1):3389
published
Determined structures of cagrilintide bound to each of the three amylin receptors (AMY1R, AMY2R and AMY3R) and to the calcitonin receptor, each in an active, Gs-coupled state.
Reports that cagrilintide binds these receptors in an amylin-like mode, and that, compared with rat amylin, salmon calcitonin and other amylin-based peptides, it induces distinct conformational dynamics in the receptor complexes.
Development of Cagrilintide, a Long-Acting Amylin Analogue.
Kruse T, Hansen JL, Dahl K, et al., Journal of Medicinal Chemistry, 2021;64(15):11183-11194
published
Reports the development of cagrilintide, which the authors describe as a stable, lipidated, long-acting amylin analogue, and the structure-activity work that led to its selection for clinical development. The authors identify natural amylin's strong tendency to form amyloid fibrils as the central difficulty in designing an analogue of it.
AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors: Pharmacological Comparison with Six Selective and Nonselective Agonists.
Fletcher MM, Keov P, Truong TT, et al., The Journal of Pharmacology and Experimental Therapeutics, 2021;377(3):417-440
published
Profiled AM833 (cagrilintide) across 25 pharmacological measures of receptor binding, activation and regulation, and describes it as a nonselective agonist at the amylin receptors — heterodimers of the calcitonin receptor with receptor activity-modifying proteins — and at the calcitonin receptor.
Compared cagrilintide with pramlintide (selective for amylin receptors), salmon calcitonin (nonselective), two other lipidated analogues, human calcitonin and rat amylin, and reports that its pharmacological profile differs from each of them.
Context
The two laboratory publications agree on the targets: cagrilintide acts at the amylin receptors and at the calcitonin receptor, rather than at the amylin receptors alone. Neither measured anything in people, and the human studies on this page measured endpoints and safety, not which receptor produced them.
Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants.
Gabe MBN, Fuhr R, Sinn A, et al., Diabetes, Obesity and Metabolism, 2024;26(12):5805-5811
published
Double-blind, randomised, placebo-controlled thorough QT study in healthy participants. Cagrilintide was given at escalating doses over the study period. To test that the assay could detect prolongation, the placebo arms also received a single dose of moxifloxacin as a positive control, in a nested crossover.
105 participants: 53 received cagrilintide and 52 placebo.
The primary endpoint was the time-matched change from baseline in heart-rate-corrected QT interval (Fridericia, QTcF) at 12, 24, 48 and 72 hours after the last dose. At all four measurement points, the upper limit of the two-sided 90% confidence interval for the placebo-adjusted change was below 10 ms, the threshold the study set for concluding there was no clinically relevant prolongation. Moxifloxacin demonstrated the assay's sensitivity.
Limitations
A thorough QT study answers one question — does the compound lengthen the QT interval enough to matter — in healthy volunteers, over a short exposure. It supports no statement about any other outcome.
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.
Lau DCW, Erichsen L, Francisco AM, et al., The Lancet, 2021;398(10317):2160-2172
published
Multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial at 57 sites in ten countries. Participants were assigned to one of five cagrilintide arms, to liraglutide, or to placebo, for 26 weeks, followed by 6 weeks without the study product. Masking covered active versus placebo, not the different active arms.
706 participants were assigned to cagrilintide (100 to 102 per arm), 99 to liraglutide and 101 to placebo, between March and August 2019.
Body weight, mean percent reduction from baseline (primary endpoint)
Randomised, controlled · Week 26 · Adults without diabetes, with a body-mass index of at least 30 kg/m², or at least 27 kg/m² with hypertension or dyslipidaemia · Analysis set: Trial product estimand (all randomly assigned participants, assuming adherence)
Arm
Reported
Cagrilintide (highest dose)
10.8% (11.5 kg)
Liraglutide
9.0% (9.6 kg)
Placebo
3.0% (3.3 kg)
Across the five cagrilintide arms, mean reductions in body weight at week 26 ranged from 6.0% to 10.8% (6.4 to 11.5 kg), against 3.0% (3.3 kg) with placebo; the estimated differences from placebo ranged from 3.0 to 7.8 percentage points (p < 0.001). The abstract does not give the three middle-dose arms individually, and they are not reproduced here. The trial reports similar reductions under its second estimand, which counts participants regardless of adherence.
The reduction with the highest cagrilintide dose was greater than with liraglutide: estimated difference 1.8 percentage points (p = 0.03). Participants and investigators knew which active product had been assigned; masking covered only active versus placebo.
73 participants (10%) stopped the study product permanently, at similar rates across groups, mostly because of adverse events (30; 4%). 29 participants (4%) withdrew from the trial.
The most frequent adverse events were gastrointestinal disorders — for example nausea, constipation and diarrhoea — and reactions at the site where each dose was given. Gastrointestinal adverse events were reported in 41% to 63% of participants across the cagrilintide arms, against 32% with placebo; nausea in 20% to 47%, against 18%.
What this study establishes
Every cagrilintide arm separated from placebo on the primary endpoint at week 26. What the abstract does not show is the shape of the relationship between amount and effect: it names the top arm and the range, not the three in between, so this page prints the range rather than drawing a line through points it does not have.
Limitations
Twenty-six weeks, in adults without diabetes. The comparison with liraglutide is the weakest figure on the card: the trial was not masked between its active arms, so participants knew which product they had. Gastrointestinal adverse events were more common in every cagrilintide arm than on placebo, and belong to the same study and the same 26 weeks as the figures above them.
A ClinicalTrials.gov search returned 40 interventional records naming Cagrilintide as an intervention on 2026-09-24. The 4 listed here were selected to show how the registered research is organised, by phase.
Each entry shows registry fields only, as ClinicalTrials.gov listed them when fetched. None of them reports a result here. Published findings are under Published research, each with its publication.
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Design
Randomized, parallel assignment, quadruple-blind
Enrollment
7,101 (actual)
Status
Active, not recruiting
Start
2023-03-01
Primary completion
2027-09-01 (estimated)
Study completion
2027-10-14 (estimated)
Last update posted
2026-08-31
Last verified
2026-09-24
Compared with related compounds
Classification, structure, recorded targets, evidence types and FDA status only, each read from the two compounds' own pages. These comparisons do not compare study results.
Not shown (no Drugs@FDA application record verified for this page)
An FDA approved drug product containing semaglutide exists. Source: Drugs@FDA, Applications NDA 209637, NDA 213051, NDA 215256 and NDA 218316.
References
Published studies reviewed (5)
Development of Cagrilintide, a Long-Acting Amylin Analogue. — Kruse T, Hansen JL, Dahl K, et al., Journal of Medicinal Chemistry, 2021;64(15):11183-11194
AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors: Pharmacological Comparison with Six Selective and Nonselective Agonists. — Fletcher MM, Keov P, Truong TT, et al., The Journal of Pharmacology and Experimental Therapeutics, 2021;377(3):417-440
Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. — Cao J, Belousoff MJ, Johnson RM, et al., Nature Communications, 2025;16(1):3389
DOI 10.1038/s41467-025-58680-y · PMID 40204768 · PMC11982234
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. — Lau DCW, Erichsen L, Francisco AM, et al., The Lancet, 2021;398(10317):2160-2172
DOI 10.1016/S0140-6736(21)01751-7 · PMID 34798060 · NCT03856047
Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. — Gabe MBN, Fuhr R, Sinn A, et al., Diabetes, Obesity and Metabolism, 2024;26(12):5805-5811
DOI 10.1111/dom.15951 · PMID 39279639 · NCT05804162
