Entry 0020Rev 1.0Amylin analogue

Cagrilintide

Lipidated 37-residue amylin analogue · C194H312N54O59S2

Reviewed

2 Nov 2026

Scientific editor

[Name, PhD]

References

10 sources

Cagrilintide is a long-acting copy of amylin, a hormone released with insulin after meals. Novo Nordisk changed six residues so it does not clump into fibrils as amylin does, and added a C20 fatty chain that binds albumin.1

It is being developed alone and with semaglutide as CagriSema. A US application for CagriSema was filed in December 2025; at this revision neither form is approved anywhere.7,9

Residues

37

Avg mass

4409.1 g/mol

REDEFINE 1, with sema

−20.4% at 68 wk

Licensed

Not yet

01

Identity

Value
SequenceKCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP-NH2; disulfide bridge Cys2–Cys7
Fatty chainC20 diacid through a γ-glutamyl linker at the N-terminal lysine
Changes from human amylinN14E, V17R, A25P, S28P, S29P, Y37P
FormulaC194H312N54O59S2
Avg mass4409.1 g/mol
CAS1415456-99-3
DeveloperNovo Nordisk
02

History

  1. Phase 1b with semaglutide, design paper and phase 2 trial of cagrilintide alone published.1,2,3

  2. Phase 2 trial of CagriSema in type 2 diabetes published.4

  3. REDEFINE 1 and REDEFINE 2 phase 3 results published.5,6

  4. Novo Nordisk files for US approval of CagriSema for weight management.7

  5. REDEFINE 4 misses non-inferiority against tirzepatide in a head-to-head trial.8

  6. US decision expected around the turn of 2026 and 2027; not approved at this revision.9

03

What the trials measured

TrialPeopleDurationMain resultSource
Phase 2, alone706 adults with obesity26 weeksWeight −6.0% to −10.8% by dose against −3.0% on placebo; top dose ahead of liraglutide[3]
Phase 2, CagriSema92 adults with type 2 diabetes32 weeksWeight −15.6% with the combination, −8.1% cagrilintide alone, −5.1% semaglutide alone[4]
REDEFINE 13,417 adults with obesity, no diabetes68 weeksWeight −20.4% CagriSema, −11.5% cagrilintide, −14.9% semaglutide, −3.0% placebo[5]
REDEFINE 21,206 adults with obesity and type 2 diabetes68 weeksWeight −13.7% against −3.4% on placebo[6]
REDEFINE 4809 adults, open-label, against tirzepatide84 weeks−20.2% against −23.6%; non-inferiority not shown[8]

Gastrointestinal side effects were the most common in every trial: about 80% of people on CagriSema in REDEFINE 1, against 40% on placebo.5

04

Regulatory and sport status

As of this revision. General information, not legal advice.

WhereStatus
USCagriSema application filed December 2025 and under review; not approved. Cagrilintide alone is in phase 3.7,9
UK, EUNot approved. No application found.
SportNot named on the 2026 WADA list. While it has no approval for human use, it falls under class S0, non-approved substances.10
05

Open questions

  1. How much cagrilintide adds to semaglutide over the long term, after REDEFINE 4 fell short against tirzepatide.8
  2. Cardiovascular outcomes and long-term safety, still being studied.
  3. Whether the balance between amylin and calcitonin receptors, and the gut side effects, are the best this class can do.
06

Common questions

What is CagriSema?

A once-weekly combination of cagrilintide and semaglutide from Novo Nordisk, tested in the REDEFINE trials.

Is cagrilintide approved?

Not at this revision. A US application for CagriSema was filed in December 2025.

How much weight loss did the trials show?

In REDEFINE 1, 20.4% at 68 weeks with CagriSema, 11.5% with cagrilintide alone and 3.0% with placebo.

How is it different from semaglutide?

Cagrilintide copies amylin and acts on amylin and calcitonin receptors. Semaglutide copies GLP-1. CagriSema combines the two.

Is cagrilintide banned in sport?

It is not named, but as an unapproved substance it falls under WADA class S0.

—

See also

Semaglutide Entry 0007Tirzepatide Entry 0008Retatrutide Entry 0005Semaglutide vs tirzepatide vs retatrutide Comparison
07

References

  1. Kruse T, et al. Development of cagrilintide, a long-acting amylin analogue. J Med Chem. 2021;64(15):11183–11194. PMID 34288673
  2. Enebo LB, 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 33894838
  3. Lau DCW, 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 34798060
  4. Frias JP, 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 37364590
  5. Garvey WT, et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity. N Engl J Med. 2025;393(7):635–647. PMID 40544433
  6. Davies MJ, et al. Cagrilintide–semaglutide in adults with overweight or obesity and type 2 diabetes. N Engl J Med. 2025;393(7):648–659. PMID 40544432
  7. Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema. Press release, 18 December 2025. novonordisk.com
  8. Novo Nordisk. CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial; the primary endpoint was not achieved. Company announcement, 23 February 2026.
  9. Novo Nordisk. Financial report for the period 1 January to 30 June 2026. 4 August 2026.
  10. World Anti-Doping Agency. The 2026 Prohibited List (in force 1 January 2026). wada-ama.org Class S0.

Peptidarium Library. Cagrilintide (entry 0020), revision 1.0, 2 November 2026. peptidarium.com/library/cagrilintide

08

Revision history

RevDateChangeBy
1.02 Nov 2026Entry created.[Scientific editor]

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