Cagrilintide

What it is

Cagrilintide (development code AM833) is a long-acting amylin analog, not a GLP-1 medicine, though it is almost always discussed alongside one. Amylin is a natural pancreatic hormone that works alongside insulin to slow gastric emptying and promote satiety. Cagrilintide is a modified, fatty-acid-linked version of that hormone, engineered the same way semaglutide was, so it can be dosed once weekly by subcutaneous injection instead of the multiple daily injections required by the older amylin drug pramlintide. Cagrilintide has been studied alone (phase 2, doses 0.3-4.5 mg weekly) and, more prominently, combined with semaglutide 2.4 mg as the fixed-dose product CagriSema, across a phase 1b trial, a phase 2 trial in type 2 diabetes, and the large phase 3 REDEFINE program. In these trials, cagrilintide plus semaglutide produced substantially more weight loss than semaglutide alone, with gastrointestinal side effects as the main tolerability issue. As of August 2026, neither cagrilintide nor CagriSema is approved by the FDA or any other regulatory agency; Novo Nordisk filed a New Drug Application for CagriSema in December 2025, with an FDA decision expected later in 2026. Because it remains investigational, there is no manufacturer label, and any reconstitution, storage, or dosing information found outside clinical trials is community-reported only, never clinically established.

Dose ranges

Study-backed ranges carry a source you can open. Community ranges are widely reported but not clinically established - treat them as what people do, not as advice.

Reconstitution & storage

No FDA-approved product or manufacturer reconstitution instructions exist for cagrilintide, since it is not an approved drug. The figures here are community-reported conventions from peptide-vendor and dosing-calculator sites, not clinical or manufacturer specifications: commonly listed research-use vial sizes of 3, 5, or 10 mg are reconstituted with 1-2 mL bacteriostatic water (for example, a 5 mg vial with 1 mL yields about 5 mg/mL, or with 2 mL yields about 2.5 mg/mL). Vial sizes and volumes vary by supplier and could not be independently verified.

Common stacks

Interactions & cautions

Cagrilintide has no FDA-approved label, so there is no official drug-interaction section for it. Across the published trials (phase 1b Enebo et al 2021, phase 2 Lau et al 2021 monotherapy and Frias et al 2023 CagriSema, and phase 3 REDEFINE 1 Garvey et al 2025 and REDEFINE 2 Davies et al 2025), the dominant tolerability issue was gastrointestinal: nausea, vomiting, decreased appetite, early satiety, and dyspepsia, generally mild to moderate and similar in character to GLP-1 receptor agonists. A dedicated thorough-QT study found cagrilintide 4.5 mg was not associated with clinically relevant QTc prolongation (Gabe et al 2024). Dedicated pharmacokinetic studies found renal or hepatic impairment did not meaningfully change cagrilintide exposure (Nielsen et al 2026). The most important interaction signal concerns hypoglycemia: in the phase 3 REDEFINE 2 trial in people with type 2 diabetes, the two severe hypoglycemia events reported both occurred in participants who were also taking a sulfonylurea. This fits the general mechanism of amylin analogs: by slowing gastric emptying and suppressing glucagon, they can unmask or worsen hypoglycemia from insulin or insulin secretagogues, which is why the related, FDA-approved amylin analog pramlintide (Symlin) carries a boxed warning for severe hypoglycemia when combined with insulin. Because cagrilintide is investigational and, in practice, often sourced outside regulated pharmacy channels, product purity, actual labeled content, and sterility are additional unverified risks that clinical-trial material does not carry.

Questions people ask

Sources

1. [1]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(10286):1736-1748. PMID 33894838studyCagrilintide's mechanism (amylin/calcitonin receptor agonist), elimination half-life of 159-195 hours (about 7-8 days), doses 0.16-4.5 mg once weekly co-administered with semaglutide 2.4 mg, and weight-loss results at week 20 (up to 17.1% with cagrilintide 2.4 mg plus semaglutide).
2. [2]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(10317):2160-2172. PMID 34798060studyCagrilintide monotherapy dose range 0.3-4.5 mg once weekly and weight reductions of 6.0%-10.8% versus 3.0% with placebo at 26 weeks.
3. [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(10403):720-730. PMID 37364590studyCagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) in type 2 diabetes produced a mean bodyweight change of -15.6% at week 32.
4. [4]Garvey WT, Bluher M, Osorto Contreras CK, et al; REDEFINE 1 Study Group. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635-647. PMID 40544433studyREDEFINE 1 phase 3 trial (n=3417): CagriSema 2.4 mg/2.4 mg produced -20.4% mean body weight change versus -3.0% placebo at 68 weeks (treatment-policy estimand); gastrointestinal adverse events in 79.6% of the CagriSema group versus 39.9% placebo.
5. [5]Davies MJ, Bajaj HS, Broholm C, et al; REDEFINE 2 Study Group. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025;393(7):648-659. PMID 40544432studyREDEFINE 2 phase 3 trial in type 2 diabetes (n=1206): CagriSema produced -13.7% mean body weight change versus -3.4% placebo at 68 weeks; 73.5% reached HbA1c 6.5% or lower versus 15.9% placebo; gastrointestinal adverse events in 72.5% versus 34.4% placebo.
6. [6]Gabe MBN, Fuhr R, Sinn A, et al. Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants. Diabetes Obes Metab. 2024;26(12):5805-5811. PMID 39279639studyCagrilintide 4.5 mg once weekly was not associated with clinically relevant QTcF prolongation versus placebo in 105 healthy participants.
7. [7]Nielsen MJF, Becker NP, Duus HHH, et al. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet. 2026;65(7):1087-1099. PMID 42228334studySingle subcutaneous doses of cagrilintide 0.6-0.9 mg produced comparable exposure across normal, mild, moderate, and severe renal or hepatic impairment groups, with no serious adverse events.
8. [8]Kruse T, Hansen JL, Dahl K, et al. Development of Cagrilintide, a Long-Acting Amylin Analogue. J Med Chem. 2021;64(15):11183-11194. PMID 34288673studyMedicinal chemistry rationale: cagrilintide is a stabilized, lipidated (fatty-acid-acylated) amylin analog designed to extend half-life beyond the short-acting, thrice-daily amylin analog pramlintide, enabling once-weekly dosing.
9. [9]D'Ascanio AM, Mullally JA, Frishman WH. Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity. Cardiology in Review. 2024;32(1):83-90. PMID 36883831reviewGeneral framing that cagrilintide is an amylin analog being developed in combination with the GLP-1 agonist semaglutide for weight management (abstract only; full text is not open access).
10. [10]PubChem Compound Summary for CID 171397054, Cagrilintide.referenceMolecular formula C194H312N54O59S2 and molecular weight approximately 4409 g/mol for cagrilintide.
11. [11]ClinicalTrials.gov. Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes. NCT04982575.regulatoryRegistry record for the Frias et al 2023 phase 2 trial: cagrilintide 2.4 mg plus semaglutide 2.4 mg versus each component plus placebo, sponsored by Novo Nordisk, 92 participants.
12. [12]ClinicalTrials.gov. Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (REDEFINE 1). NCT05567796.regulatoryRegistry record confirming REDEFINE 1 as a phase 3, Novo Nordisk-sponsored trial of cagrilintide 2.4 mg plus semaglutide 2.4 mg versus placebo in about 3,400 participants with obesity, with body weight change to week 68 as the primary outcome.
13. [13]DailyMed search results for "cagrilintide".regulatoryConfirms cagrilintide has zero FDA drug label results in DailyMed, i.e. no approved US prescribing information exists.
14. [14]DailyMed. SYMLIN (pramlintide acetate) injection, prescribing information (AstraZeneca Pharmaceuticals LP).labelBoxed warning: "SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes," the class precedent cited for cagrilintide's interaction warning (pramlintide is the only FDA-approved amylin analog; cagrilintide itself carries no label).
15. [15]Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. PR Newswire, December 18, 2025.regulatoryNovo Nordisk submitted an FDA New Drug Application for CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) on December 18, 2025; "The FDA is expected to review the CagriSema application in 2026," confirming cagrilintide/CagriSema remain unapproved.
16. [16]CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM. PR Newswire.regulatorySponsor press release quoting REDEFINE 1 results under two statistical estimands: "weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group" (trial product estimand, assumes full adherence) and "20.4% at 68 weeks versus 3.0% for the placebo group" (treatment policy estimand).
17. [17]American Diabetes Association Meeting News. REDEFINE trials advance cagrilintide-semaglutide combination treatment for weight management.referenceVerbatim: "CagriSema was associated with a low incidence of hypoglycemia, with two severe hypoglycemia events reported, both in patients who were receiving concomitant sulfonylurea drugs," the cagrilintide-specific basis for this page's interaction warning; also reports REDEFINE 1 and REDEFINE 2 topline weight-loss figures.
18. [18]DosingCalc. Cagrilintide Dosing & Reconstitution Guide (AM833).communityCommunity-reported reconstitution practice (5 mg or 10 mg vials with 1-2 mL bacteriostatic water), storage (lyophilized refrigerated about 2 years; reconstituted refrigerated and used within about 4 weeks), and a self-titration schedule from 0.25 mg to 2.4 mg weekly. Not a clinical or manufacturer source.
19. [19]CalcMyPeptide. Cagrilintide Dosing Guide: Half-Life, Reconstitution & Protocol.communityCommunity-reported reconstitution example (5 mg vial with 2 mL bacteriostatic water) and restates the ~7-8 day half-life and 0.3-4.5 mg/week dose range already established by study sources. Not a clinical or manufacturer source.