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Investigational peptide drugHuman trialsIn clinical trials

Cagrilintide

Cagrilintide

Last reviewed October 27, 2026 · 13 sources · Written for general readers · Compare with another compound →

The bottom line

Cagrilintide is an experimental, long acting copy of the fullness hormone amylin. Used alone in a 68 week trial, it led to about 11.5% weight loss versus 3% on placebo, less than when paired with semaglutide. It is not approved, and FDA says it cannot legally be compounded.

Where the evidence stands

What it is

Cagrilintide is an experimental, long acting version of amylin, a hormone from the pancreas that helps people feel full.[1] It is developed by Novo Nordisk.[2]

Natural amylin clumps into fibers and lasts only a short time, so chemists changed its structure and attached a fatty acid to make a stable form that lasts much longer.[3]

On its own, cagrilintide is not approved anywhere. It is mainly being developed as part of CagriSema, a weekly shot that combines it with semaglutide.[2] PubChem lists its formula as C194H312N54O59S2 and its CAS number as 1415456-99-3.[4]

Name
Cagrilintide (Cagrilintide)
Type
Investigational peptide drug
CAS number
1415456-99-3
Formula
C194H312N54O59S2
Molecular weight
About 4409 g/mol

How it works

Cagrilintide mimics amylin, a pancreas hormone that promotes a feeling of fullness.[1]

  • In mice, it acts through amylin receptors in the brainstem, a part of the brain that helps control hunger. Mice missing two of these receptor types lost less weight on it.[5]
  • It is built to last much longer than natural amylin, so it can be given as a weekly shot.[1][3]
  • Novo Nordisk is testing it together with semaglutide, a GLP-1 drug, because the two act on different fullness signals.[2]

The brain pathway is shown in mice. In people, the main proven effect is weight loss.

What the research shows

We keep animal and human evidence apart. A result in animals is a reason to study something in people, not proof that it works in people.

Animal and lab studies

Mouse studies point to brainstem amylin receptors

  • Obese mice on a high fat diet given daily cagrilintide shots for 3 weeks lost about 3.4 g of body weight.[5]
  • Food intake dropped sharply in the first days of treatment, but only in normal mice, not in mice lacking two amylin receptor parts.[5]
  • Cagrilintide switched on nerve cells in the dorsal vagal complex and the parabrachial nucleus, brainstem areas linked to fullness and nausea.[5]
  • Lab chemistry work showed that natural amylin tends to form fibers, which is why a stable, longer lasting form had to be built before human testing.[3]

Limit: These are short mouse studies and say little about long term effects in people.

Human studies

Placebo controlled trials show real but smaller weight loss than combination therapy

  • Phase 1b trial: 96 adults with overweight or obesity got weekly cagrilintide or placebo on top of semaglutide for 20 weeks. At the higher cagrilintide strengths, weight fell about 15% to 17% versus 8% to 10% with semaglutide alone. Nearly everyone in both groups had at least one side effect, mostly stomach related.[9]
  • Phase 2 trial: 906 adults with overweight or obesity and no diabetes got weekly cagrilintide (706 people), daily liraglutide or placebo for 26 weeks. Weight fell 6.0% to 10.8% on cagrilintide versus 9.0% on liraglutide and 3.0% on placebo.[1]
  • In that trial, about 10% of people stopped treatment early, similar across groups, and 4% stopped because of side effects.[1]
  • Diabetes trial: 92 adults with type 2 diabetes got cagrilintide, semaglutide or both for 32 weeks. Weight fell 8.1% on cagrilintide alone, 5.1% on semaglutide and 15.6% on both. HbA1c fell 0.9, 1.8 and 2.2 points. Side effects were reported by 80%, 71% and 68%.[8]
  • REDEFINE 1: 302 of the 3,417 adults in this 68 week phase 3 trial got cagrilintide alone. Weight fell 11.5% versus 3.0% on placebo counting everyone, and 11.8% in people who kept taking it.[6][7]
  • REIMAGINE 2, a large 2026 diabetes trial, also had a cagrilintide only group, but the maker's announcement did not report its results.[10]
  • Novo Nordisk said in 2025 it would start a dedicated phase 3 program of cagrilintide alone, and a trial in people with type 2 diabetes is registered.[7][11]

Limit: Results for cagrilintide alone over 68 weeks come mostly from a company presentation of one trial arm, and long term safety is unknown.

Claims check

The most common claims about this compound, and what studies actually found. Verdicts rate the evidence, not whether you should use it.

Causes weight loss on its own

Shown in people

In REDEFINE 1, 302 adults with obesity or overweight got cagrilintide alone for 68 weeks. Counting everyone, weight fell 11.5% versus 3.0% on placebo, and about 31% lost at least 15%, versus about 5%.[6][7] An earlier 26 week trial in 706 people on cagrilintide found 6.0% to 10.8% loss versus 3.0% on placebo.[1]

Works as well as GLP-1 drugs

Mixed results

In the 26 week trial, the highest strength led to 10.8% loss versus 9.0% on liraglutide, an older GLP-1 drug.[1] In a small 32 week trial of 92 adults with type 2 diabetes, cagrilintide alone led to 8.1% weight loss versus 5.1% on semaglutide, but blood sugar fell only about half as much.[8] Large trials mainly test it as an add on to semaglutide.[6]

Makes semaglutide work better

Shown in people

In REDEFINE 1, the combination of cagrilintide and semaglutide led to 20.4% weight loss versus 3.0% on placebo over 68 weeks, more than cagrilintide alone.[6][7] In the 92 person diabetes trial, the combination led to 15.6% loss versus 5.1% on semaglutide and 8.1% on cagrilintide.[8]

Lowers blood sugar

Mixed results

In the 32 week diabetes trial, HbA1c (a three month blood sugar average) fell 0.9 points on cagrilintide alone versus 1.8 points on semaglutide and 2.2 points on the combination. There was no placebo group.[8]

Easier on the stomach than GLP-1 drugs

Mixed results

In the 26 week trial, gut side effects hit 41% to 63% of people on cagrilintide versus 32% on placebo, and nausea 20% to 47% versus 18%.[1] In REDEFINE 1, only 1.0% quit cagrilintide because of nausea versus 0.1% on placebo.[7] No trial has directly compared side effect rates with a GLP-1 drug in a large group.[8]

Curbs appetite through the brain

Only in animals

In obese mice, food eaten on the first day fell from about 2.7 g to 1.2 g with cagrilintide, and brainstem hunger areas lit up. Mice lacking two amylin receptor types responded less.[5] Human trials measured weight, not brain activity.[1]

Known risks and side effects

  • Stomach and gut side effects. Gut side effects such as nausea, constipation and diarrhea happened in 41% to 63% of people on cagrilintide versus 32% on placebo, and nausea alone in 20% to 47% versus 18%.[1]
  • Injection site reactions. Reactions where the shot was given were among the most common side effects in the phase 2 trial.[1]
  • Unknown long term safety. It is not approved on its own, so there is no FDA label and no long term safety record. Trials of it alone have lasted 68 weeks at most.[2][7]
  • Unregulated products. FDA says cagrilintide cannot be used in compounding because it is not part of any approved drug and has not been shown safe and effective. Anything sold online is unregulated and of unknown quality.[12]
  • Banned in tested sports. WADA bans at all times any drug that has no government approval for human use.[13]

Regulatory status

Today: Cagrilintide is investigational and not FDA approved as a single drug. FDA says it cannot legally be compounded.[12]

  1. Results of the phase 2 weight loss trial of cagrilintide alone were published.[1]
  2. Novo Nordisk presented REDEFINE 1 results for cagrilintide alone and announced a dedicated phase 3 program called RENEW.[7]
  3. Novo Nordisk asked FDA to approve CagriSema, which contains cagrilintide.[2]
  4. FDA's updated GLP-1 page said cagrilintide cannot be used in compounding.[12]

Sources

  1. 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 34798060
  2. Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema. December 18, 2025. Company announcement
  3. 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 34288673
  4. National Center for Biotechnology Information. PubChem Compound Summary for CID 171397054, Cagrilintide. PubChem CID 171397054
  5. Carvas AO, Leuthardt A, Kulka P, et al. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3. EBioMedicine. 2025;118:105836. PMID 40609154
  6. Garvey WT, Bluher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635-647. PMID 40544433
  7. Novo Nordisk. Novo Nordisk presents phase 3 data for next generation amylin cagrilintide leading to advancement into dedicated clinical programme. September 16, 2025 (press release reposted by BioSpace). Company press release
  8. 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 37364590
  9. 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 33894838
  10. Novo Nordisk. Company announcement: CagriSema shows superior HbA1c reduction and weight loss versus semaglutide in adults with type 2 diabetes in REIMAGINE 2. February 2, 2026. Company announcement
  11. ClinicalTrials.gov. Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide. NCT07220759. NCT07220759
  12. U.S. Food and Drug Administration. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Content current as of October 1, 2026. FDA
  13. World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. WADA 2026 List
Medical disclaimer

This page is educational information only. It is not medical advice and does not replace care from a licensed medical provider. Do not use this page to decide whether to take any substance. Talk to a licensed medical provider first.

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