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Cagrilintide: The Amylin Analogue Behind CagriSema, Explained

October 6, 2026 · Metabolic Research, Education · 9 min read

Abstract 3D render of a white molecular structure

Most of the conversation about metabolic peptides centres on one gut hormone, GLP-1. Cagrilintide is built on a different hormone altogether: amylin, which the pancreas releases alongside insulin every time you eat. Paired with semaglutide as CagriSema, it is now under review at the US FDA, and one of its key early trials was led from the University of Calgary.

This guide explains what amylin does, how cagrilintide was engineered from it, what the trials found, and what to check before ordering research-grade cagrilintide in Canada.

The short answer

  • Cagrilintide is a long-acting, fatty-acid-modified analogue of the hormone amylin, developed by Novo Nordisk. It acts on amylin receptors and the related calcitonin receptor.
  • Amylin is a 37-amino-acid hormone released with insulin. It slows stomach emptying, restrains glucagon after meals and signals fullness through the brainstem.
  • In a 26-week phase 2 trial led by the University of Calgary’s David Lau, weight fell 6.0% to 10.8% across cagrilintide doses versus 3.0% with placebo, and the highest dose outperformed liraglutide.
  • In the 68-week REDEFINE 1 trial, CagriSema produced 20.4% weight loss versus 3.0% with placebo. Cagrilintide alone produced 11.5% and semaglutide alone 14.9%.
  • CagriSema was filed with the FDA in December 2025, with a decision expected by late 2026. Neither it nor cagrilintide is approved anywhere, and research-grade cagrilintide is a laboratory reagent.

Cagrilintide

Long-acting amylin analogue from Novo Nordisk. The “Cagri” in CagriSema.

Human amylin, the 37-amino-acid hormone cagrilintide is modelled on:

  1. K
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  37. Y

Outlined beads: the two cysteines that form a disulfide bridge. Blue beads: positions 25, 28 and 29, where the earlier drug pramlintide swaps in prolines to stop amylin from clumping. Cagrilintide adds its own changes, including a fatty-acid side chain, described in Novo Nordisk’s 2021 development paper.

Class
Long-acting amylin analogue with a fatty-acid side chain
Targets
Amylin receptors and the related calcitonin receptor
Developer
Novo Nordisk
Furthest stage
Phase 3, mainly as CagriSema with semaglutide
Status
Not approved anywhere; CagriSema is under FDA and Health Canada review

Where the evidence stands

  1. Cell studies
  2. Animal studies
  3. Human studies
  4. Controlled clinical trials

Large randomized trials exist, though most test the CagriSema combination rather than cagrilintide alone.

Amylin, the other pancreatic hormone

Amylin was identified in 1987, when researchers purifying the amyloid deposits found in the pancreas of people with type 2 diabetes discovered they were made of a 37-amino-acid peptide. Beta cells release amylin together with insulin after meals. Its job is to complement insulin: it slows how fast the stomach empties, holds back the post-meal rise in glucagon, and signals fullness, largely through the area postrema in the brainstem.

Amylin has a practical problem: it clumps. Human amylin readily forms amyloid fibrils, which made the natural hormone unusable as a drug. The first workaround, pramlintide, replaced three amino acids with prolines to keep it soluble and was approved in the US in 2005. But pramlintide is short-acting and had to be injected with meals, which limited its use.

From amylin to cagrilintide

Cagrilintide is Novo Nordisk’s answer to both problems. Its developers engineered an amylin analogue that resists fibrillation and carries a fatty-acid side chain, the same broad strategy used for semaglutide. The fatty acid lets the peptide bind albumin in the blood, which protects it from rapid breakdown and clearance and gives it a half-life long enough for once-weekly use in trials.

Pharmacologically, cagrilintide is described as non-selective. It activates amylin receptors, which are calcitonin receptors paired with one of three receptor activity-modifying proteins (RAMP1, RAMP2 or RAMP3), and it also activates the calcitonin receptor on its own.

Why pair it with GLP-1?

GLP-1 and amylin both reduce appetite and slow digestion, but they come from different cells and work through different receptors and partly different brain regions. That makes them candidates for adding together rather than duplicating each other.

Amylin and GLP-1: two hormones, one fullness network Gut L-cells release GLP-1, which acts on the GLP-1 receptor targeted by semaglutide. Pancreatic beta cells release amylin with insulin, which acts on amylin receptors targeted by cagrilintide. Both slow stomach emptying, restrain glucagon after meals and send fullness signals to the brain. Gut L-cells release GLP-1 after meals Pancreatic beta cells release amylin with insulin GLP-1 receptor Amylin receptors targeted by semaglutide targeted by cagrilintide Overlapping effects Slower stomach emptying · less glucagon after meals Fullness signals to the brain Different receptors and partly different brain sites. Simplified schematic.
CagriSema pairs two partly independent fullness signals, each acting through its own receptor family.

A small phase 1b study published in 2021 tested exactly that idea. Adding cagrilintide to semaglutide over 20 weeks produced more weight loss than semaglutide with placebo, which launched the phase 3 program.

Research-grade cagrilintide with a batch-matched COA.

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The trial record

  1. May 2021: phase 1b, in combinationCagrilintide added to semaglutide in 95 adults over 20 weeks, with greater weight loss than semaglutide plus placebo (Enebo et al., The Lancet). The University of Calgary’s David Lau was senior author.
  2. November 2021: phase 2, on its own706 adults at 57 sites in ten countries, including Canada. Over 26 weeks, weight fell 6.0% to 10.8% across doses versus 3.0% with placebo, and the highest dose beat liraglutide, 10.8% versus 9.0% (Lau et al., The Lancet).
  3. 2023: phase 2 in type 2 diabetesCagriSema compared with each of its components in adults with type 2 diabetes (Frias et al., The Lancet).
  4. June 2025: phase 3 results publishedREDEFINE 1, in obesity without diabetes, and REDEFINE 2, in type 2 diabetes, appear in The New England Journal of Medicine.
  5. December 2025: FDA submissionNovo Nordisk files CagriSema with the US FDA for weight management.
  6. February 2026: head-to-head with tirzepatideIn the open-label, 84-week REDEFINE 4 trial, CagriSema produced 23.0% weight loss versus 25.5% for tirzepatide and did not meet its primary goal.
  7. March 2026: Health Canada reviewHealth Canada accepts Novo Nordisk Canada’s cagrilintide–semaglutide submission for review.
  8. Late 2026: FDA decision expectedAs of this writing, CagriSema is not approved anywhere.

REDEFINE 1 in numbers

REDEFINE 1 is the trial that isolates cagrilintide’s contribution, because it compared the combination with each component on its own and with placebo.

Treatment arm (68 weeks)All randomized participantsParticipants who stayed on treatment
CagriSema (cagrilintide + semaglutide)−20.4%−22.7%
Semaglutide alone−14.9%−16.1%
Cagrilintide alone−11.5%−11.8%
Placebo−3.0%−2.3%

The trial enrolled 3,417 adults with obesity, or overweight plus at least one related condition, and no diabetes, randomized in a 21:3:3:7 ratio. The protocol allowed flexible dosing, and only 57.3% of CagriSema participants were on the top dose at week 68, compared with 82.5% of those on cagrilintide alone. In REDEFINE 2, which enrolled 1,206 adults with type 2 diabetes, CagriSema produced 13.7% weight loss versus 3.4% with placebo.

Why two numbers per arm? The first counts everyone randomized, including people who stopped treatment; the second estimates the effect in people who stayed on it. Our GLP-1 research map explains how to read these figures across trials.

The Calgary connection

Cagrilintide’s early clinical story runs through Alberta. Professor David Lau of the University of Calgary led the 2021 phase 2 trial that established cagrilintide’s dose-response as a single agent, and he was senior author of the phase 1b study that first combined it with semaglutide. The phase 2 trial recruited at sites in ten countries, Canada among them.

It is a reminder that a good deal of the metabolic-peptide science now reaching regulators was built partly in Canadian clinics and laboratories.

What’s established and what isn’t

Reasonably well established

  • Cagrilintide produces dose-dependent weight loss on its own in a 26-week phase 2 trial.
  • Combined with semaglutide, it produced more weight loss than either component alone over 68 weeks.
  • The combination was less effective than tirzepatide in an open-label head-to-head trial.

Open questions

  • Long-term safety, including cardiovascular outcomes.
  • Whether higher-dose versions of the combination, now in planning, change the picture.
  • Where cagrilintide alone fits, if anywhere, beside GLP-1-based drugs.
  • How much tolerability depends on slow, flexible dose escalation.

Sourcing cagrilintide in Canada

Lipidated peptides such as cagrilintide are more demanding to make and to test than short, simple sequences. Before ordering, check that:

  • Identity is confirmed by mass spectrometry against cagrilintide’s published structure. Peptides of this size usually appear as several multiply charged ions, so the report should state the deconvoluted mass. See our COA guide.
  • The HPLC method suits lipidated peptides. The fatty-acid side chain makes cagrilintide strongly retained and prone to sticking, so the method and chromatogram matter more than a bare purity figure. See our HPLC testing guide.
  • Storage is cold, dry and dark. Amylin-derived peptides are aggregation-prone by nature. See our peptide storage guide.
  • The lot number on the COA matches your vial.
Cagrilintide 5mg research vial from Pure Peptides CanadaCagrilintideLong-acting amylin analogueView product and COA Retatrutide 10mg research vial from Pure Peptides CanadaRetatrutideGIP, GLP-1 and glucagon triple agonistView product and COA Mazdutide 10mg research vial from Pure Peptides CanadaMazdutideGLP-1 and glucagon dual agonistView product and COA Survodutide 10mg research vial from Pure Peptides CanadaSurvodutideGlucagon and GLP-1 dual agonistView product and COA
Independent testingEvery batch is tested by Janoshik Analytical.
Batch-matched COAThe report matches the lot you receive.
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Research use only. Cagrilintide from Pure Peptides Canada is a laboratory reagent for in-vitro research. It is not CagriSema or any approved drug, it is not for human or veterinary use, and nothing in this article is dosing or medical guidance.

Frequently asked questions

What is cagrilintide?

Cagrilintide is a long-acting, fatty-acid-modified analogue of the pancreatic hormone amylin, developed by Novo Nordisk. It activates amylin receptors and the related calcitonin receptor, and it is the cagrilintide half of CagriSema.

Is cagrilintide a GLP-1 agonist?

No. Cagrilintide acts on amylin receptors, not the GLP-1 receptor. It is often discussed alongside GLP-1 drugs because it is paired with semaglutide, a GLP-1 receptor agonist, in CagriSema.

What is CagriSema?

CagriSema is Novo Nordisk’s fixed combination of cagrilintide and semaglutide. In the 68-week REDEFINE 1 trial it produced 20.4% average weight loss versus 3.0% with placebo, counting all randomized participants. It was submitted to the US FDA in December 2025 and is not yet approved.

How much weight loss did cagrilintide produce in trials?

On its own, cagrilintide produced 6.0% to 10.8% weight loss across doses over 26 weeks in a phase 2 trial, versus 3.0% with placebo, and 11.5% over 68 weeks in REDEFINE 1, counting all randomized participants.

Is cagrilintide approved in Canada?

No. Cagrilintide is not approved as a medicine anywhere, including Canada. Its combination with semaglutide, CagriSema, was accepted for review by Health Canada in March 2026 but has not been authorized. Research-grade cagrilintide is a laboratory reagent and is not for human use.

What is the Canadian connection to cagrilintide?

Professor David Lau of the University of Calgary led the 2021 phase 2 trial of cagrilintide on its own, which included Canadian sites, and was senior author of the 2021 phase 1b study that first combined it with semaglutide.

Why does amylin need to be modified to work as a drug?

Natural human amylin clumps into amyloid fibrils and is cleared quickly. Pramlintide solved the clumping with proline substitutions but still had to be injected with meals. Cagrilintide was engineered to resist aggregation and carries a fatty-acid side chain that extends its half-life.

Cagrilintide for laboratory research

Lyophilized cagrilintide with an independent, batch-matched COA, tracked delivery across Canada and pricing in Canadian dollars.

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Related reading

References

  1. Cooper GJ, Willis AC, Clark A, et al. Purification and characterization of a peptide from amyloid-rich pancreases of type 2 diabetic patients. Proc Natl Acad Sci USA. 1987;84(23):8628–8632.
  2. Kruse T, et al. Development of cagrilintide, a long-acting amylin analogue. J Med Chem. 2021;64(15):11183–11194.
  3. 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;397:1736–1748.
  4. 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;398:2160–2172. DOI
  5. Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). N Engl J Med. 2025.
  6. Davies MJ, et al. Cagrilintide–semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2). N Engl J Med. 2025.
  7. Novo Nordisk. Company announcement on REDEFINE 1 results, 20 December 2024. SEC filing
  8. Novo Nordisk. Company announcement on REDEFINE 4 results and CagriSema regulatory status, 23 February 2026. SEC filing
  9. Health Canada. New drug submissions under review (list current to August 31, 2026). Government of Canada

For laboratory research use only. Not for human or veterinary use. This article summarizes published research for educational purposes and is not medical advice. Nothing here is intended to diagnose, treat, cure or prevent any disease.