Key facts
- Cagrilintide is a long-acting, lipidated amylin analogue from Novo Nordisk, built on the pramlintide backbone and given once weekly by subcutaneous injection in trials.[1][2]
- On its own it cut weight by 6.0% to 10.8% at 26 weeks (0.3 to 4.5 mg) in phase 2 and by 11.8% at 68 weeks (2.4 mg) in REDEFINE 1.[4][13]
- Its half-life is 159 to 195 hours, roughly one week.[5]
- Combined with semaglutide as CagriSema, it gave 20.4% weight loss at 68 weeks against 3.0% on placebo.[11]
- It is not approved anywhere. CagriSema was submitted to the US FDA in December 2025.[17][18]
What Is Cagrilintide?
Cagrilintide is a long-acting amylin analogue developed by Novo Nordisk for weight management, tested once weekly at 0.3 to 4.5 mg in its phase 2 trial.[1][4]
| Feature | Cagrilintide |
|---|---|
| Developer | Novo Nordisk |
| Development code | NNC0174-0833[3] |
| Drug class | Long-acting amylin analogue that also activates the calcitonin receptor[2][8] |
| Structure | Pramlintide backbone, N-terminal γGlu linker and C20 fatty diacid[2] |
| Dosing in trials | Once weekly, subcutaneous[4] |
| Doses studied | 0.16 mg to 4.5 mg weekly[5][4] |
| Half-life | 159 to 195 hours[5] |
| Best result alone | -10.8% at 26 wk (4.5 mg); -11.8% at 68 wk (2.4 mg)[4][13] |
| Main combination | CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg)[11] |
| Status | Investigational; CagriSema submitted to the FDA Dec 2025[17] |
Pramlintide, the first amylin analogue, needs three injections a day because of its short half-life. Novo Nordisk made cagrilintide a stable, lipidated analogue so that it lasts long enough for weekly dosing.[1] Novo Nordisk is developing it on its own for weight management and in the fixed-dose combination CagriSema.[15] For the hormone it copies, see what is amylin.
How Cagrilintide Works
Cagrilintide activates all three amylin receptors (AMY1, AMY2 and AMY3) and the calcitonin receptor, which is why it is described as a dual amylin and calcitonin receptor agonist.[2]
- It mimics amylin. Amylin is a 37-amino-acid hormone released with insulin that acts as a regulator of glucose and energy balance, largely through brain areas outside the blood-brain barrier.[7]
- It binds like amylin. Cryo-EM structures show cagrilintide binding amylin receptors in an amylin-like way, while causing receptor dynamics distinct from other amylin-family peptides.[2]
- It acts on brain amylin receptors. In mice lacking RAMP1 and RAMP3, cagrilintide was less potent, showing that its weight effect depends on the AMY1 and AMY3 receptors.[6]
- It reduces hunger. Novo Nordisk says cagrilintide and semaglutide work by reducing hunger and increasing fullness, so people eat less.[13]
- It is non-selective. Cagrilintide activates calcitonin and amylin receptors with similar potency, unlike eloralintide, which was designed to favour AMY1.[8][9]
Cagrilintide Dosage in Clinical Trials
Cagrilintide has been tested at once-weekly doses from 0.16 mg to 4.5 mg, and 2.4 mg is the dose used in the phase 3 REDEFINE trials and in CagriSema.[5][4][11]
| Trial | Doses (once weekly) | Escalation as reported | Length |
|---|---|---|---|
| Phase 1b, with semaglutide 2.4 mg (n = 96) | 0.16, 0.30, 0.60, 1.2, 2.4 or 4.5 mg | Co-escalated with semaglutide every 4 weeks over 16 weeks, then 4 weeks at target dose[5] | 20 weeks |
| Phase 2, alone (n = 706 on cagrilintide) | 0.3, 0.6, 1.2, 2.4 or 4.5 mg | Escalation period of up to 6 weeks[4] | 26 weeks |
| Phase 2, type 2 diabetes (n = 92) | Escalated to 2.4 mg | Not detailed in the abstract[10] | 32 weeks |
| REDEFINE 1, phase 3 (n = 302 on cagrilintide alone) | 2.4 mg | 0.25, 0.5, 1.0 and 1.7 mg steps over 16 weeks, then 52 weeks at 2.4 mg[12] | 68 weeks |
| Kidney and liver impairment studies | Single dose of 0.6 mg or 0.9 mg | None[15] | Single dose |
- In phase 2, weight fell by 6.0% to 10.8% across the five doses against 3.0% on placebo, and 4.5 mg beat liraglutide 3.0 mg (10.8% vs 9.0%).[4]
- In the phase 1b, 2.4 mg with semaglutide gave 17.1% weight loss at week 20, against 9.8% for semaglutide with placebo.[5]
- REDEFINE 1 used a flexible protocol: after 68 weeks, 82.5% of people on cagrilintide 2.4 mg alone were on the top dose.[13]
- Kidney or liver impairment did not change cagrilintide exposure in a clinically relevant way after a single dose.[15]
Cagrilintide Side Effects
Nausea is the most common side effect of cagrilintide: it affected 20% to 47% of people across phase 2 doses (placebo 18%) and 23.8% on 2.4 mg in REDEFINE 1 (placebo 12.6%).[4][12]
| Adverse event | Cagrilintide 2.4 mg | Placebo |
|---|---|---|
| Any gastrointestinal disorder | 54.0% | 39.9% |
| Nausea | 23.8% | 12.6% |
| Constipation | 20.5% | 11.6% |
| Diarrhoea | 15.2% | 12.1% |
| Vomiting | 7.0% | 4.1% |
| Dyspepsia | 6.0% | 3.0% |
| Administration-site reactions | 17.5% | 3.0% |
In the same trial, nausea affected 43.7% of people on semaglutide 2.4 mg and 55.0% on CagriSema, so cagrilintide alone caused less nausea than either.[12] In phase 2, gastrointestinal events affected 41% to 63% on cagrilintide against 32% on placebo, and administration-site reactions were among the most frequent events. Permanent treatment stopping (10% overall) was similar across groups and mostly due to adverse events (4%).[4]
Cagrilintide Half-Life
Cagrilintide has a half-life of 159 to 195 hours (about 6.6 to 8.1 days), with peak blood levels a median of 24 to 72 hours after a dose.[5]
- These figures come from the phase 1b trial, at doses of 0.16 to 4.5 mg given with semaglutide 2.4 mg, whose own half-life was 145 to 165 hours.[5]
- Exposure rose in proportion to the cagrilintide dose, and cagrilintide did not change semaglutide exposure or elimination.[5]
- A half-life of about a week supports once-weekly dosing; pramlintide needs three daily injections.[1]
- Eloralintide, Lilly’s amylin analogue, has a longer half-life of 310 to 366 hours.[9]
CagriSema (Cagrilintide and Semaglutide)
CagriSema is a once-weekly fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, and it cut body weight by 20.4% at 68 weeks against 3.0% on placebo in REDEFINE 1.[11]
Trial product estimand (had everyone stayed on treatment), from Novo Nordisk’s headline results. Treatment-policy figures: 20.4%, 14.9%, 11.5% and 3.0%.
| Trial | Population | Length | CagriSema | Comparator |
|---|---|---|---|---|
| REDEFINE 1 (n = 3,417) | Overweight or obesity, no diabetes | 68 wk | -20.4% | -3.0% placebo[11] |
| REDEFINE 2 (n = 1,206) | Overweight or obesity with type 2 diabetes | 68 wk | -13.7% | -3.4% placebo[14] |
| Phase 2 (n = 92) | Type 2 diabetes | 32 wk | -15.6% | -5.1% semaglutide, -8.1% cagrilintide[10] |
| Phase 1b (n = 96) | Overweight or obesity | 20 wk | -17.1% (cagrilintide 2.4 mg) | -9.8% semaglutide with placebo[5] |
Gastrointestinal adverse events affected 79.6% on CagriSema vs 39.9% on placebo in REDEFINE 1, and 72.5% vs 34.4% in REDEFINE 2, mostly transient and mild to moderate.[11][14] In REDEFINE 2, 73.5% of people on CagriSema reached an HbA1c of 6.5% or less, against 15.9% on placebo.[14]
Cagrilintide vs Eloralintide
Cagrilintide reached 10.8% weight loss at 26 weeks on its own, against 20.1% at 48 weeks for Lilly’s eloralintide, but the trials differ in length and design and no head-to-head trial exists.[4][16]
The main design difference is selectivity. Cagrilintide activates amylin and calcitonin receptors with similar potency, while eloralintide is about 12 times more potent at the AMY1 receptor than at the calcitonin receptor. Eloralintide also lasts longer, with a half-life of 310 to 366 hours.[8][9] Full comparison: eloralintide vs cagrilintide.
Is Cagrilintide FDA Approved?
No. Cagrilintide is not approved by the FDA or any other regulator, and CagriSema, which contains it, was submitted to the FDA in December 2025.[17][18]
Novo Nordisk’s release of 29 October 2026 states that CagriSema is not approved in the United States or anywhere else.[18] The only approved amylin analogue is pramlintide (Symlin), approved in 2005 for diabetes.[19]
Frequently Asked Questions
What is cagrilintide?
Cagrilintide is a long-acting amylin analogue from Novo Nordisk, given once weekly in trials. It activates amylin and calcitonin receptors and is being developed for weight management, alone and with semaglutide as CagriSema.
What is the dose of cagrilintide?
Trials have tested once-weekly doses from 0.16 mg to 4.5 mg. The phase 3 REDEFINE trials and CagriSema use 2.4 mg, reached after 16 weeks of dose escalation in REDEFINE 1. There is no approved dose; this is trial data, not advice.
What are the side effects of cagrilintide?
Mostly gastrointestinal. In REDEFINE 1, cagrilintide 2.4 mg caused nausea in 23.8% (placebo 12.6%), constipation in 20.5% and diarrhoea in 15.2%. Administration-site reactions affected 17.5%.
How long does cagrilintide stay in your body?
Its half-life is 159 to 195 hours, roughly a week, with peak levels 24 to 72 hours after a dose. That is why trials give it once weekly.
Is cagrilintide FDA approved?
No. Cagrilintide is not approved anywhere. CagriSema, its combination with semaglutide, was submitted to the US FDA in December 2025.
What is the difference between cagrilintide and CagriSema?
Cagrilintide is the amylin analogue on its own. CagriSema combines cagrilintide 2.4 mg with semaglutide 2.4 mg. In REDEFINE 1, CagriSema gave 22.7% weight loss at 68 weeks against 11.8% for cagrilintide alone, had everyone stayed on treatment.
Sources
- Kruse T, et al. Development of cagrilintide, a long-acting amylin analogue. J Med Chem 2021;64:11183-11194. DOI 10.1021/acs.jmedchem.1c00565
- Cao J, et al. Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. Nature Communications 2025;16:3389. DOI 10.1038/s41467-025-58680-y
- ClinicalTrials.gov NCT03856047, cagrilintide (NNC0174-0833) phase 2
- Lau DCW, et al. Cagrilintide phase 2. The Lancet 2021;398:2160-2172. DOI 10.1016/S0140-6736(21)01751-7
- Enebo LB, et al. Cagrilintide with semaglutide 2.4 mg, phase 1b. The Lancet 2021;397:1736-1748. DOI 10.1016/S0140-6736(21)00845-X
- Carvas AO, et al. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3 (mice). eBioMedicine 2025;118:105836. DOI 10.1016/j.ebiom.2025.105836
- Hay DL, et al. Amylin: pharmacology, physiology, and clinical potential. Pharmacological Reviews 2015;67:564-600. DOI 10.1124/pr.115.010629
- Bhattachar S, et al. Eloralintide 12-week multiple-dose phase 1. Diabetes, Obesity and Metabolism 2026;28(4):2651-2660. DOI 10.1111/dom.70439
- Briere DA, et al. Discovery and first-in-human study of eloralintide. Molecular Metabolism 2025;102:102271. DOI 10.1016/j.molmet.2025.102271
- Frias JP, et al. CagriSema in type 2 diabetes, phase 2. The Lancet 2023;402:720-730. DOI 10.1016/S0140-6736(23)01163-7
- Garvey WT, et al. CagriSema REDEFINE 1. N Engl J Med 2025;393:635-647. DOI 10.1056/NEJMoa2502081
- Garvey WT, et al. Efficacy and safety of cagrilintide 2.4 mg: data from REDEFINE 1. Novo Nordisk presentation, EASD 2025
- Novo Nordisk company announcement, 20 Dec 2024: REDEFINE 1 headline results
- Davies MJ, et al. CagriSema REDEFINE 2 (type 2 diabetes). N Engl J Med 2025;393:648-659. DOI 10.1056/NEJMoa2502082
- Nielsen MJF, et al. Renal or hepatic impairment and cagrilintide pharmacokinetics. Clinical Pharmacokinetics 2026;65:1087-1099. DOI 10.1007/s40262-026-01654-0
- Eli Lilly press release, 6 Nov 2025: eloralintide phase 2 results
- Novo Nordisk company announcement: CagriSema submitted to the US FDA, December 2025
- Novo Nordisk US press release, 29 Oct 2026: CagriSema and Wegovy data at ObesityWeek 2026
- FDA. SYMLIN (pramlintide acetate) prescribing information, revised 12/2019
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