Cagrilintide: the basics
What is it?
A lab-made, longer-lasting copy of amylin, a hormone made by the pancreas that helps you feel full. It is often paired with semaglutide in a combination called CagriSema.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗What do people claim it helps with?
Weight loss, especially when combined with semaglutide, and better blood-sugar control in type 2 diabetes.
What has research actually shown?
Controlled trials found more weight loss than placebo with cagrilintide alone, and larger average weight loss when it was combined with semaglutide. Results vary from person to person.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗Has this been demonstrated in people?
Phase 2 trials of cagrilintide alone and large phase 3 trials of the combination in adults, paid for by the manufacturer. Long-term heart-outcome results are not available yet.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗What side effects, risks and unknowns should I understand?
Nausea, constipation, diarrhoea and vomiting were common in trials, and more frequent with the combination. Long-term safety is still being studied.
FDA safety information 1 ↗Research paper 2 ↗Is it an approved medicine?
No FDA-approved medicine contains cagrilintide. FDA says it has not been found safe and effective for any condition and cannot be used in compounding.
FDA safety information ↗Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.
How is it used or studied?
Tested as a once-weekly injection in clinical trials, alone or together with semaglutide. There is no approved product to buy.
Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.
A common misunderstanding
Cagrilintide is not pramlintide (an older approved amylin drug) and not semaglutide. CagriSema results are for the combination, not cagrilintide alone.
What should I ask a clinician?
- What diagnosis or goal are we trying to address, and what established options are available?
- Was the expected benefit shown in people like me, using this exact product?
- How could my medicines, health conditions or pregnancy plans affect the risks?
- What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
- Peptide
- A short chain of amino acids, the building blocks of proteins.
- Preclinical
- Research in cells, tissues or animals before dependable treatment evidence in people.
- Controlled trial
- A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
- Biomarker
- A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
Cagrilintide Evidence & Clinical Profile
Human Study Limits
Cagrilintide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.
Laboratory & In Vivo Assays
Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.
What is Cagrilintide?
Cagrilintide (and CagriSema, cagrilintide + semaglutide) is Cagrilintide is an investigational long-acting version of amylin, a pancreatic hormone that promotes fullness. Novo Nordisk has tested it alone and combined with semaglutide (CagriSema) in large phase 3 trials. Neither cagrilintide nor CagriSema is FDA-approved. Aliases include: CagriSema, cagrilintide-semaglutide, long-acting amylin analogue.
- Sequence (one-letter)
- C20 diacid-γGlu-KCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP-NH2 (disulfide between the two Cys)
- Molecular formula
- C194H312N54O59S2
- Molecular weight
- 4409 g/mol (PubChem computed)
- CAS Number
- 1415456-99-3
- UNII Code
- AO43BIF1U8
- PubChem CID
- 171397054
Identifiers are for the free base; cagrilintide hydrochloride carries UNII 3SBY6D7WH7.
Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.
Clinical Trials & Human Cohorts
Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.
Once-weekly cagrilintide for weight management in people with overweight and obesity [1]
What was reported
Weight fell 6.0% to 10.8% across five cagrilintide dose levels versus 3.0% with placebo. The highest dose group lost more than the liraglutide group (10.8% vs 9.0%).
What limits the conclusion
Short, 26-week trial funded by Novo Nordisk. Gastrointestinal adverse events affected 41%–63% on cagrilintide versus 32% on placebo, mainly nausea.
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity [2]
What was reported
Mean weight change was −20.4% with CagriSema versus −3.0% with placebo (difference −17.3 percentage points).
What limits the conclusion
Tests the combination, so it cannot isolate cagrilintide's own contribution from the headline result. Gastrointestinal adverse events: 79.6% vs 39.9%.
Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes [3]
What was reported
Mean weight change was −13.7% with CagriSema versus −3.4% with placebo; 73.5% versus 15.9% reached an HbA1c of 6.5% or less.
What limits the conclusion
Weight loss was smaller than in people without diabetes. Gastrointestinal adverse events: 72.5% vs 34.4%.
Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2) [4]
What was reported
HbA1c fell 1.91 percentage points with CagriSema versus 1.75 with semaglutide alone (difference −0.16), meeting the superiority endpoint.
What limits the conclusion
The added glucose-lowering benefit over semaglutide alone was small. Adverse events were reported by most participants in every active group.
How the compound may work
Mechanisms describe how Cagrilintide may affect biological processes. Laboratory findings and patient outcomes answer different questions.
Amylin receptor agonism
Natural amylin is a pancreatic hormone that promotes satiety (fullness). Cagrilintide activates amylin receptors; pairing it with semaglutide adds a second, complementary pathway (GLP-1 receptor agonism). [4]
Long-acting design
Native amylin clumps into fibrils and the older analogue pramlintide needs several injections a day. Cagrilintide was engineered as a stable, lipidated (fatty-acid-linked) analogue so it lasts long enough for once-weekly use. [5]
Areas Being Studied
These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.
Obesity
Weight loss with cagrilintide alone and with semaglutide (REDEFINE program); a cagrilintide-only phase 3 program (RENEW) is under way. [2]
Type 2 diabetes
Glucose control and weight in type 2 diabetes (REDEFINE 2, REIMAGINE program). [4]
Cardiovascular outcomes
REDEFINE 3 is testing CagriSema in people with established cardiovascular disease; results are not yet available. [8]
Compare the study designs.
| Study | Design / sample | Outcome type | Key limitation |
|---|---|---|---|
| Phase 2: cagrilintide alone · 2021 [1] | Phase 2 double-blind, placebo- and active-controlled dose-finding randomized trial; 26 weeks n = 906 |
Clinical endpoint evaluation | Short, 26-week trial funded by Novo Nordisk. Gastrointestinal adverse events affected 41%–63% on cagrilintide versus 32% on placebo, mainly nausea. |
| REDEFINE 1: CagriSema in obesity · 2025 [2] | Phase 3a double-blind, placebo- and active-controlled randomized trial; 68 weeks n = 3417 |
Clinical endpoint evaluation | Tests the combination, so it cannot isolate cagrilintide's own contribution from the headline result. Gastrointestinal adverse events: 79.6% vs 39.9%. |
| REDEFINE 2: CagriSema with type 2 diabetes · 2025 [3] | Phase 3a double-blind, placebo-controlled randomized trial; 68 weeks n = 1206 |
Clinical endpoint evaluation | Weight loss was smaller than in people without diabetes. Gastrointestinal adverse events: 72.5% vs 34.4%. |
| REIMAGINE 2: glucose control · 2026 [4] | Phase 3 double-blind, placebo- and active-controlled randomized trial; 68 weeks n = 2713 |
Clinical endpoint evaluation | The added glucose-lowering benefit over semaglutide alone was small. Adverse events were reported by most participants in every active group. |
Regulatory Status & Clinical Safety
Regulatory Classification
United States, checked 11 October 2026: neither cagrilintide nor CagriSema is FDA-approved; no record appears in Drugs@FDA or DailyMed. FDA states cagrilintide is not a component of any FDA-approved drug, has not been found safe and effective for any condition, and cannot be used in compounding. Semaglutide, the other half of CagriSema, is separately approved in other products.
Safety Realities & Impurities
Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.
Clinical Trials Registry Records
Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1) [6]
- Planned enrollment
- 3400 (estimated enrollment)
- Posted results
- Pending in registry
- Sponsor
- Novo Nordisk A/S
- Last updated
- 2026-09-30
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (REDEFINE 2) [7]
- Planned enrollment
- 1200 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Novo Nordisk A/S
- Last updated
- 2026-01-28
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels [8]
- Planned enrollment
- 7101 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Novo Nordisk A/S
- Last updated
- 2026-08-31
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide (RENEW 1) [9]
- Planned enrollment
- 300 (estimated enrollment)
- Posted results
- Pending in registry
- Sponsor
- Novo Nordisk A/S
- Last updated
- 2026-08-06
WADA & Anti-Doping Regulations
WADA Anti-Doping Status
Cagrilintide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.
Research Timeline
-
2021
Molecule described
Novo Nordisk chemists publish the development of cagrilintide as a long-acting amylin analogue. [5]
-
2021
Phase 2 monotherapy results
A 26-week dose-finding trial reports weight loss versus placebo. [1]
-
2025
REDEFINE 1 and 2 published
Phase 3a trials of CagriSema report 68-week weight results with and without type 2 diabetes. [2]
-
2026
REIMAGINE 2 published
CagriSema shows a small added HbA1c reduction over semaglutide alone in type 2 diabetes. [4]
-
2026
Current status
Not FDA-approved. FDA states cagrilintide cannot be used in compounding. [10]
What Researchers Still Don't Know
Long-term safety profiles
Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.
Optimal dose-response thresholds
Comparative trials optimizing minimal effective exposure versus adverse event rates.
Formulation bioavailability
Differences between oral, subcutaneous, and modified peptide delivery vehicles.
References
Primary sources verified against PubMed / NLM and regulatory databases.
- Phase 2 RCT DOI: 10.1016/S0140-6736(21)01751-7 ↗ (external website)
- Phase 3 RCT DOI: 10.1056/NEJMoa2502081 ↗ (external website)
- Phase 3 RCT DOI: 10.1056/NEJMoa2502082 ↗ (external website)
- Phase 3 RCT DOI: 10.1016/S2213-8587(26)00125-7 ↗ (external website)
-
Medicinal chemistry
Development of Cagrilintide, a Long-Acting Amylin Analogue ↗ (external website)
DOI: 10.1021/acs.jmedchem.1c00565 ↗ (external website) - Registry Record
- Registry Record
- Registry Record
- Registry Record
-
FDA Safety Communication
FDA's concerns with unapproved GLP-1 drugs used for weight loss ↗ (external website)