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Cagrilintide

Long-acting amylin analog (amylin and calcitonin receptor agonist)

Status

In clinical trials

Not approved anywhere; Novo Nordisk filed CagriSema (a fixed-dose weekly combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) with the FDA for chronic weight management in December 2025 and expects a decision in the fourth quarter of 2026.

Evidence

Strong

For the CagriSema combination, several large phase 3 trials (REDEFINE 1, 2 and 4, REIMAGINE) are published or reported; cagrilintide alone has one phase 2 trial and monotherapy arms within phase 3.

In sport

WADAProhibited (WADA)

Cagrilintide is an investigational long-acting analog of the pancreatic hormone amylin, given by weekly injection. It is mainly developed with semaglutide as CagriSema, a fixed-dose combination for obesity that produced about 20% average weight loss in phase 3 and is under FDA review.

Structure

37 residues
  1. aK1N-terminal amine acylated with a C20 fatty diacid via γGlu linker (albumin binding)

Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.

Sequence as text
C20 diacid-γGlu-K-C-N-T-A-T-C-A-T-Q-R-L-A-E-F-L-R-H-S-S-N-N-F-G-P-I-L-P-P-T-N-V-G-S-N-T-P-NH2

What it is used for

  • Obesity and overweight, as CagriSema (studied)
  • Type 2 diabetes with overweight or obesity, as CagriSema (studied)
  • Obesity, as monotherapy (studied)

How it works

Amylin is released with insulin after meals and signals fullness. Cagrilintide activates amylin receptors (the calcitonin receptor paired with a RAMP protein) and the calcitonin receptor itself, acting in brain regions that control appetite, which reduces food intake. Native amylin readily forms amyloid fibrils, so cagrilintide was engineered as a stable analog, and an N-terminal C20 fatty diacid binds albumin for weekly dosing. In CagriSema it adds an amylin signal to semaglutide's GLP-1 signal.

How strong the evidence is

StrongSeveral large randomised controlled trials in people.

In REDEFINE 1 (3,417 adults with obesity), CagriSema produced 20.4% mean weight loss at 68 weeks versus 3.0% with placebo; the monotherapy arms lost 14.9% (semaglutide) and 11.5% (cagrilintide). REDEFINE 2 (1,206 adults with type 2 diabetes) found 13.7% versus 3.4%. In the open-label REDEFINE 4 (809 adults, 84 weeks), CagriSema (23.0%) did not show non-inferiority to tirzepatide 15 mg (25.5%). A 2021 phase 2 trial of cagrilintide alone reported 6.0% to 10.8% weight loss at 26 weeks versus 3.0% with placebo.

Risks and side effects

  • Gastrointestinal effects (nausea, vomiting, diarrhea, constipation) in about 80% on CagriSema versus 40% on placebo in REDEFINE 1
  • Injection-site reactions, more common in cagrilintide-containing arms
  • CagriSema carries the known risks of its semaglutide component, such as pancreatitis and gallbladder disease
  • Long-term safety of amylin-receptor agonism is still being studied
  • Not approved: products sold outside clinical trials are unregulated, with unknown identity, purity, dose and sterility

Regulatory status

No regulator has approved this peptide for any use.

Status by country

JurisdictionStatusSource
USUnited StatesNo authorised medicineSource 15
EUEuropean UnionNo authorised medicineSource 16
UKUnited KingdomNo authorised medicineSource 17
AUAustraliaNo authorised medicineSource 18
CACanadaNo authorised medicineSource 19
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Cagrilintide to watch

  1. Phase 3Active, not recruiting

    RENEW 1(opens the source in a new tab)

    Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

    Primary completion expected May 11, 2027300 participantsSponsor: Novo Nordisk A/SNCT07220642

  2. Phase 3Active, not recruiting

    RENEW 2(opens the source in a new tab)

    Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

    Primary completion expected May 12, 2027330 participantsSponsor: Novo Nordisk A/SNCT07220759

  3. Phase 3Active, not recruiting

    REDEFINE 3(opens the source in a new tab)

    REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

    Primary completion expected Sep 1, 20277,101 participantsSponsor: Novo Nordisk A/SNCT05669755

  4. Phase 3Completed

    CagriSema vs tirzepatide in obesity(opens the source in a new tab)

    A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

    Primary completion Dec 8, 2025809 participantsSponsor: Novo Nordisk A/SNCT06131437

  5. Phase 3Completed

    REIMAGINE 2(opens the source in a new tab)

    A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

    Primary completion Nov 19, 20252,734 participantsSponsor: Novo Nordisk A/SNCT06065540

All trials to watch

Timeline

  1. 2027

    1. REDEFINE 3
    2. RENEW 2
    3. RENEW 1

  2. 2026

    1. ResearchBMJ review of 262 trials: semaglutide the only obesity drug linked to lower mortality
    2. Trial resultCagriSema misses non-inferiority goal against tirzepatide in REDEFINE 4

  3. 2025

    1. CagriSema vs tirzepatide in obesity
    2. REIMAGINE 2

  4. 2024

    1. Trial resultCagriSema delivers 22.7% weight loss in REDEFINE 1, below Novo's 25% expectation

Sources

  1. 01International Nonproprietary Names for Pharmaceutical Substances: Proposed INN List 123(opens the source in a new tab) World Health Organization (WHO Drug Information), 2020
  2. 02Cagrilintide (CID 171397054)(opens the source in a new tab) PubChem, U.S. National Library of Medicine
  3. 03Development of Cagrilintide, a Long-Acting Amylin Analogue(opens the source in a new tab) Journal of Medicinal Chemistry, 2021
  4. 04AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors(opens the source in a new tab) Journal of Pharmacology and Experimental Therapeutics, 2021
  5. 05Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3(opens the source in a new tab) eBioMedicine, 2025
  6. 06Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg(opens the source in a new tab) The Lancet, 2021
  7. 07Once-weekly cagrilintide for weight management in people with overweight and obesity: a phase 2 trial(opens the source in a new tab) The Lancet, 2021
  8. 08Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)(opens the source in a new tab) New England Journal of Medicine, 2025
  9. 09Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2)(opens the source in a new tab) New England Journal of Medicine, 2025
  10. 10Novo Nordisk files combo obesity drug CagriSema for FDA approval(opens the source in a new tab) BioSpace, 2025
  11. 11Novo Nordisk files for FDA approval of CagriSema(opens the source in a new tab) Novo Nordisk via PR Newswire, 2025
  12. 12Novo Nordisk's CagriSema bested by Lilly's Zepbound in head-to-head trial (REDEFINE 4)(opens the source in a new tab) Clinical Trials Arena, 2026
  13. 13Novo Nordisk financial report for the first six months of 2026 (Form 6-K)(opens the source in a new tab) U.S. Securities and Exchange Commission (EDGAR), 2026
  14. 14World Anti-Doping Code International Standard: Prohibited List 2026(opens the source in a new tab) World Anti-Doping Agency, 2025
  15. 15FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss(opens the source in a new tab) U.S. Food and Drug Administration, 2026
  16. 16Find medicine: centrally authorised medicines(opens the source in a new tab) European Medicines Agency, 2026
  17. 17MHRA Products: active substances beginning with C(opens the source in a new tab) Medicines and Healthcare products Regulatory Agency, 2026
  18. 18Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab) Therapeutic Goods Administration
  19. 19Drug Product Database online query(opens the source in a new tab) Health Canada
  1. In clinical trialsAmycretinUnimolecular GLP-1 and amylin receptor agonistNo single sequence68 WADA banned
  2. Not approvedAOD-9604Modified growth hormone fragment (research peptide)16 WADA banned
  3. ApprovedDulaglutideGLP-1 receptor agonist (Fc fusion protein)31
  4. ApprovedExenatideGLP-1 receptor agonist39
  5. ApprovedInsulin (human)Peptide hormone (insulin)51 WADA banned

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.