What Is Cagrilintide? Benefits, Research & Safety
A long-acting amylin analogue developed by Novo Nordisk, researched for its role in appetite regulation, satiety signalling, and weight management, including as part of the CagriSema combination with semaglutide.
UK summary: Investigational long-acting amylin analogue from Novo Nordisk. Phase 3 evaluation as CagriSema (with semaglutide). Not currently a UK-licensed medicine; access is via clinical trial participation only.
Quick Facts
Overview
Cagrilintide — evidence and risk at a glance
Twenty standard modules scored against the Peptide Authority evidence grading methodology. Missing modules indicate the field has not yet been characterised editorially — treat absences as uncertainty rather than reassurance.
01Evidence snapshot
Investigational long-acting amylin analogue from Novo Nordisk. Phase 3 evaluation as CagriSema (with semaglutide). Not currently a UK-licensed medicine; access is via clinical trial participation only.
02Human evidence grade
03Preclinical evidence grade
04Regulatory status
- UK: Not approved by the MHRA. Cagrilintide is an investigational compound; CagriSema is in Phase 3 clinical development.
- EU: Not authorised by the European Medicines Agency. Phase 3 trials for CagriSema are ongoing.
- Notes: Cagrilintide is primarily being developed as part of the CagriSema combination with semaglutide. The REDEFINE Phase 3 clinical programme is evaluating CagriSema across multiple indications including obesity and type 2 diabetes. Novo Nordisk has indicated plans for regulatory submissions based on Phase 3 data. Standalone cagrilintide is not currently being pursued as a separate commercial product.
05Approved medical uses
None in the UK or EU as a finished medicine. (Or: not yet documented; treat as absence rather than approval.)
06Unapproved / promotional claims
- Available now for UK private prescription.
- Better than tirzepatide for weight loss.
- Safe to use as monotherapy or with semaglutide at home.
- Same as the licensed CagriSema combination.
07Common internet claims
- Marketed by grey-market vendors in 'CagriSema' bundles with semaglutide.
- Sold by online retailers as research-only injectable.
- Promoted in pre-launch weight-loss communities ahead of Novo Nordisk regulatory submission.
08Claim vs evidence
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “Available for UK weight management” | E | No | High | Cagrilintide is investigational; not licensed in the UK or anywhere. Sellers offering it are operating outside the regulated supply chain. |
| “CagriSema is more effective than Wegovy alone” | B | Yes | Low | Phase 3 trial data are encouraging; UK availability awaits regulatory submission and approval. |
09Safety uncertainty score
Effectively no human safety data; safety claims are extrapolations from animal work or anecdote.
10Known adverse signals
- Phase 3 trial profile: nausea, vomiting, decreased appetite.
- Unknown long-term safety; first amylin-receptor agonist of its kind in development.
- Sterility and identity of grey-market product entirely unverified.
- Theoretical risk of combining unverified cagrilintide with licensed semaglutide.
11Drug-interaction uncertainty
Interaction picture sparse; meaningful uncertainty when combined with other medicines.
12Anti-doping status
13UK legal position
Not approved by the MHRA. Cagrilintide is an investigational compound; CagriSema is in Phase 3 clinical development.
14EU legal position
Not authorised by the European Medicines Agency. Phase 3 trials for CagriSema are ongoing.
15What this page cannot tell you
- Whether a UK-purchased 'cagrilintide' vial contains the drug at any concentration.
- Whether combining grey-market cagrilintide with a licensed GLP-1 is safe.
- What dose is appropriate in any individual outside the clinical-trial protocol.
- Whether and when MHRA approval will materialise.
16Last reviewed
17Citation quality score
18Research gaps
- REDEFINE and other Phase 3 trial results pending or recently published.
- Cardiovascular outcome data not yet finalised.
- Long-term real-world safety impossible — drug is not licensed.
19Safer alternatives / established care pathways
- Licensed Wegovy (semaglutide) or Mounjaro (tirzepatide) via NHS or GMC-registered prescriber.
- Enrolment in a registered cagrilintide / CagriSema Phase 3 trial.
- NHS Tier 2 / 3 weight management programme.
20Doctor discussion prompts
Questions to ask a qualified clinician
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Is cagrilintide / CagriSema licensed in the UK yet?
- Are there UK clinical trials I could join?
- What licensed weight-management options should I consider in the meantime?
Discovery & History
Mechanism of Action
Researched Benefits
Based on preclinical and clinical research findings:
- 1Significant appetite suppression and reduced caloric intake through central amylin receptor activation in brainstem satiety centres
- 2Clinically meaningful weight loss as monotherapy, with enhanced efficacy when combined with semaglutide in the CagriSema combination (exceeding 20% body weight reduction)
- 3Improved post-prandial glycaemic control through suppression of glucagon secretion and modulation of gastric emptying rate
- 4Reduction in HbA1c levels in participants with type 2 diabetes, supporting potential dual benefits for weight and glycaemic management
- 5Decreased waist circumference and visceral adiposity, suggesting favourable effects on body fat distribution
- 6Potential reduction in cardiovascular risk markers including improvements in blood pressure and lipid profiles
- 7Sustained weight management with once-weekly dosing, improving adherence compared to short-acting amylin analogues
- 8Possible modulation of food reward pathways, contributing to reduced cravings for energy-dense foods
Claim vs Evidence
How popular claims about Cagrilintide stack up against the current research, graded using our public evidence grading methodology.
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “Available for UK weight management” | E | No | High | Cagrilintide is investigational; not licensed in the UK or anywhere. Sellers offering it are operating outside the regulated supply chain. |
| “CagriSema is more effective than Wegovy alone” | B | Yes | Low | Phase 3 trial data are encouraging; UK availability awaits regulatory submission and approval. |
Theoretical Dosing & Protocols
| Theoretical Dosage | 2.4 mg as monotherapy; 2.4 mg cagrilintide combined with 2.4 mg semaglutide in CagriSema (dose escalation protocols used in clinical trials start at lower doses) |
| Frequency | Once weekly subcutaneous injection |
| Duration | Clinical trials have evaluated treatment periods of 68 weeks and longer; duration in practice to be determined by clinical guidelines upon approval |
| Notes | These protocols reflect published clinical trial designs and are not prescriptive recommendations. Cagrilintide is an investigational compound not approved for human use. Dose escalation is employed in clinical trials to improve gastrointestinal tolerability. Always consult a qualified healthcare professional. |
Administration Routes
Routes studied in research settings (educational only):
- Subcutaneous injection (sole route investigated in clinical trials)
| Half-Life | Stability |
|---|---|
| Approximately 5 days (roughly 120 hours), supporting once-weekly dosing; achieved through albumin-binding fatty acid acylation technology | Supplied as a solution for injection in pre-filled pen devices in clinical trial settings; storage typically at 2-8°C as per investigational product handling protocols |
Safety Profile & Known Risks
Commonly Reported Side Effects
- Nausea, particularly during initial dose escalation (most commonly reported adverse event)
- Vomiting, generally transient and decreasing over time with continued treatment
- Diarrhoea, more frequent at higher doses
- Injection site reactions including erythema, pain, and pruritus at the injection site
- Decreased appetite (pharmacologically related to mechanism of action)
- Abdominal discomfort or dyspepsia
Rare Risks & Concerns
- Hypoglycaemia, particularly when combined with insulin or insulin secretagogues (more relevant in diabetic populations)
- Acute pancreatitis (theoretical class concern; monitored in clinical trials)
- Cholelithiasis associated with rapid weight loss
- Anti-drug antibody formation (monitored in clinical programmes; clinical significance not fully established)
Contraindications
- Personal or family history of medullary thyroid carcinoma (precaution related to the semaglutide component in CagriSema)
- Multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Pregnancy and breastfeeding (no safety data; excluded from clinical trials)
- Known hypersensitivity to cagrilintide, semaglutide (for CagriSema), or any excipients
- Severe gastroparesis (amylin agonists further slow gastric emptying)
UK & EU Regulatory Context
🇬🇧 United Kingdom
Not approved by the MHRA. Cagrilintide is an investigational compound; CagriSema is in Phase 3 clinical development.
🇪🇺 European Union
Not authorised by the European Medicines Agency. Phase 3 trials for CagriSema are ongoing.
Clinical Studies Summary
CagriSema Versus Semaglutide Monotherapy or Placebo for Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials with GRADE Assessment.
CagriSema therapy was associated with superior weight reduction compared with semaglutide or placebo. In conclusion, CagriSema achieves greater weight loss than semaglutide or placebo but increases gastrointestinal adverse events, warranting careful tolerability monitoring and longer-term data.
Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression.
Cagrisema is more effective than semaglutide in reducing weight and increasing glycemic control. Cagrisema is safe and has a comparable side effect profile to currently accepted treatments. This regimen has enormous potential in dual-agonist therapy for obese patients.
Comparative Effectiveness of CagriSegma, Semaglutide, Cagrilintide and Tirzepatide in the Management of Overweight and Obesity: A Network Meta-Analysis of Randomized Clinical Trials.
Tirzepatide 15 mg and CagriSema achieve the greatest weight reduction, including ≥ 20% body weight loss. Gastrointestinal adverse events rise with treatment intensity, while serious adverse events remain comparable to placebo. These findings support dual-pathway and combination incretin therapies as preferred options for patients requiring substantial weight loss.
Comparative effectiveness of GLP-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network meta-analysis.
GLP-1RAs are efficacious in treating adults with type 2 diabetes. Compared with the placebo, tirzepatide was the most effective GLP-1RA drug for glycaemic control by reducing haemoglobin A1c and fasting plasma glucose concentrations. GLP-1RAs also significantly improved weight management for type 2 diabetes, with CagriSema performing the best for weight loss.
Efficacy and safety of GLP-1RAs for people with obesity: A systematic review based on RCT and Bayesian network meta-analysis.
CagrANDsema exerts the best effect for weight loss. In terms of current dose levels, a higher dose gets better weight-loss effects without increasing the risk of adverse events.
CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1.
CagriSema presents clinically relevant reductions in BP across a wide range of participant subgroups, including those with resistant hypertension.
Registered Trials & Regulatory Status
19 of 20 completed trials have never posted results. Unreported trials are not neutral: results that go unpublished are more often negative ones.
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
Status: Not Yet Recruiting · 80 participants · Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
Status: Recruiting · 114 participants · Novo Nordisk A/S
Conditions: Obesity, Overweight
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
Status: Active Not Recruiting · 50 participants · Novo Nordisk A/S
Conditions: Overweight, Obesity
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
Status: Recruiting · 234 participants · Novo Nordisk A/S
Conditions: Obesity, Overweight
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
Status: Recruiting · 120 participants · Novo Nordisk A/S
Conditions: Overweight, Obesity
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
Status: Recruiting · 100 participants · Novo Nordisk A/S
Conditions: Obesity
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese
Status: Recruiting · 100 participants · Novo Nordisk A/S
Conditions: Overweight, Obese
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Status: Recruiting · 460 participants · Novo Nordisk A/S
Conditions: Overweight, Obesity
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
Status: Active Not Recruiting · 330 participants · Novo Nordisk A/S
Conditions: Overweight, Obesity, Type 2 Diabetes
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
Status: Active Not Recruiting · 300 participants · Novo Nordisk A/S
Conditions: Obesity, Overweight
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
Status: Recruiting · 80 participants · Novo Nordisk A/S
Conditions: Obesity
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
Status: Recruiting · 144 participants · Novo Nordisk A/S
Conditions: Obesity
Adverse event reports (FDA FAERS)
Not applicable: no licensed product contains this peptide, so it is not reported through FAERS. This is an absence of surveillance, not evidence of safety.
Source: ClinicalTrials.gov and openFDA. Updated automatically.
Looking for Cagrilintide?
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View at SupplierFrequently Asked Questions
Questions to ask a qualified clinician about Cagrilintide
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Is cagrilintide / CagriSema licensed in the UK yet?
- Are there UK clinical trials I could join?
- What licensed weight-management options should I consider in the meantime?
UK regulatory & safety context
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