What is Cagrilintide?
Cagrilintide is an amylin analog. Amylin is a pancreatic hormone involved in satiety and gastric-emptying biology, so cagrilintide sits beside incretin drugs rather than inside the GLP-1 family. [4]
As monotherapy, cagrilintide has phase 2 dose-finding evidence for weight management. Its most visible development path is co-administered cagrilintide plus semaglutide, often called CagriSema. [4][5][6]
Recent REDEFINE publications strengthen the human evidence for CagriSema. Cagrilintide-alone and CagriSema results should stay separate because the combination includes semaglutide. [7][8][5]
What Cagrilintide is investigated for
Cagrilintide evidence is grouped by practical use case and injectable route context. Each use case separates confidence, human evidence, animal or mechanistic support, and the practical takeaway.
Semaglutide combination weight loss
Injectable
Semaglutide combination weight loss
Injectable
Combination weight loss is the most visible CagriSema use case, but the combination remains separate from cagrilintide monotherapy and regulatory approval status. [7][3][2]
Monotherapy weight reduction
Injectable
Monotherapy weight reduction
Injectable
Cagrilintide monotherapy has human weight-management evidence, while the largest effects currently come from the semaglutide combination program. [4][15][1]
Type 2 diabetes glycemic control
Injectable
Type 2 diabetes glycemic control
Injectable
Appetite control and satiety
Injectable
Appetite control and satiety
Injectable
Satiety is a plausible cagrilintide effect within weight management, but it should not be framed as a standalone approved use. [4][16]
Evidence snapshot
Overall confidence
Cagrilintide has credible late-stage human data, especially in combination with semaglutide. The main interpretation issue is keeping monotherapy and CagriSema evidence separate. [4][7]
Overall confidence is a page-level composite, not an average; it weighs evidence quality, route/molecule match, and practical limitations.
Human evidence
Human evidence includes cagrilintide monotherapy dose-finding, cagrilintide plus semaglutide studies, type 2 diabetes combination data, and published REDEFINE results. [4][5][6][7][8]
Animal / preclinical
Preclinical and receptor-mechanism research supports amylin and calcitonin receptor biology, but the practical confidence comes from human weight-management trials. [31][20][18]
Mechanism support
Amylin-analog activity gives a coherent rationale for satiety and body-weight effects, and combination trials pair that biology with semaglutide rather than replacing GLP-1 signaling. [4][5][18]
Forms & administration
Cagrilintide administration is investigational injectable content. Cagrilintide-alone trials, cagrilintide plus semaglutide trials, and unapproved research-market claims need separate handling because the combination changes both dosing context and interpretation. [4][5][7]
Dosing & protocols
The notes below separate published trial design from commonly discussed cosmetic or compounded-use patterns. They are educational context only, not a prescription or product instruction.
Typical Range
Cagrilintide-alone dose-finding used 0.3-4.5 mg once weekly by subcutaneous injection. Cagrilintide-semaglutide trials use the two drugs together; late-stage combination trials commonly describe 2.4 mg cagrilintide plus 2.4 mg semaglutide once weekly. Those combination doses should not be read as cagrilintide-alone dosing. [4][5][7][8]
Frequency
Once-weekly subcutaneous injection is the main cagrilintide pattern. Combination programs also use once-weekly coadministration with semaglutide after dose escalation. [4][5][10][11]
Timing Considerations
Trial dosing is organized around a consistent weekly injection day. The cited cagrilintide trials do not establish a meal-based, workout-based, morning, or bedtime timing advantage. [4][5][10]
Cycle Length
Cagrilintide is tracked over longer treatment windows rather than short peptide cycles. Cagrilintide-alone programs have used about 6 months, while major semaglutide-combination programs commonly run about 16 months. [4][10][11][7]
Protocol Notes
Separate logs for cagrilintide alone, semaglutide alone, and the semaglutide combination make weight-response and tolerability trends easier to interpret. The combination changes titration, GI burden, efficacy expectations, and product-quality concerns. [4][5][7][2]
What to expect
First weeks
Fullness can come sooner and appetite may be easier to manage, especially when cagrilintide is paired with semaglutide. [5][4]
3-6 months
Weight and waist reductions can become more visible as fullness and appetite control build, with larger effects in cagrilintide-semaglutide combination data. [4][7]
1 year
Weight and waist reductions can persist with continued treatment, especially in combination studies, while appetite control remains the main felt effect. [7][8]
After stopping
Fullness may fade and appetite can move back toward baseline after pausing or stopping; weight and waist changes may soften without ongoing amylin-analog exposure. [4][16]
Safety profile
Cagrilintide safety is still investigational and route-specific. The practical safety focus is GI tolerability, combination effects with semaglutide, hypoglycemia considerations in diabetes trials, and the lack of approved-product labeling. [4][6][3]
Who Cagrilintide is not for
Route-specific avoid and medical-review notes:
Drug & supplement interactions
Documented interactions are separated from theoretical or route-specific cautions.
Theoretical interactions
- Semaglutide, GLP-1, or other satiety drugs
Cagrilintide adds amylin-pathway satiety effects on top of GLP-1 therapy; pairing it with semaglutide or other GLP-1, GIP, or amylin weight-loss drugs can compound nausea, vomiting, diarrhea, constipation, and appetite-suppression effects, and safety rules outside studied cagrilintide-semaglutide protocols are not established. [5][7]
Pairing notes
Works well with
Not recommended with
Cagrilintide already layers amylin satiety onto GLP-1 therapy in studied protocols; adding extra GLP-1, GIP, or amylin agents can pile on nausea, vomiting, reduced intake, dehydration, and glucose-management uncertainty without dose rules. [5]
Regulatory status
United States
United States: not FDA-approved for human use as a drug. FDA also states cagrilintide cannot be used in compounding under federal law. [1][3][2]
| Route | FDA drug approval | 503A compounding |
|---|---|---|
| Injectable | Not Approved Cagrilintide and CagriSema are not FDA-approved for human use as drug products in the United States. [1][3][2] | Not Listed FDA states cagrilintide cannot be used in compounding under federal law and has not been found safe and effective for any condition. [2] |
Injectable
FDA drug approval
Not ApprovedCagrilintide and CagriSema are not FDA-approved for human use as drug products in the United States. [1][3][2]
503A compounding
Not ListedFDA states cagrilintide cannot be used in compounding under federal law and has not been found safe and effective for any condition. [2]
International
International status is country-specific and should be checked against local medicine registers before any product or claim is assumed lawful.
Sports & competition
For athletes, cagrilintide may fall under WADA non-approved-substance rules because it is not approved by a governmental regulatory health authority for human therapeutic use. [1][13]
How it works
Cagrilintide is a long-acting amylin analog. Its core mechanism is satiety signaling, not GLP-1 duplication, with brain amylin-receptor pathways supporting food-intake reduction. That keeps it in amylin/satiety context. [29][20]
Cagrilintide-alone data show the amylin pathway can move body weight, while CagriSema pairs that pathway with semaglutide's GLP-1 appetite, gastric-emptying, and glucose effects. [4][5][7]
Combination results still belong to the combination: weight loss, nausea, appetite suppression, and tolerability in CagriSema trials cannot be assigned cleanly to cagrilintide alone or generalized to other amylin drugs. [5][7]
Research gaps & open questions
What the current literature has not yet settled about Cagrilintide:
The biggest practical gap is product maturity: approved labeling would define route, dose, contraindications, warnings, manufacturing controls, and real-world risk communication. [1][3]
Cagrilintide-alone evidence needs to remain separate from CagriSema evidence so readers do not assign semaglutide-driven effects to amylin analog monotherapy. [4][7]
More long-term data are needed on maintenance, discontinuation, lean mass, gallbladder and GI tolerability, diabetes-medication interactions, and special populations. [10][11]
Common questions
Is cagrilintide a GLP-1 drug?
Is CagriSema FDA-approved?
Myths & misconceptions
Myth
Amylin analogs and GLP-1 agonists are the same kind of peptide.
Myth
CagriSema results prove cagrilintide alone works the same way.
Reality
Combination studies include semaglutide, so they cannot be used as cagrilintide-alone proof. [7]
History & discovery
Cagrilintide's history starts in long-acting amylin-analog development, not GLP-1 development. It became prominent because CagriSema paired cagrilintide's satiety biology with semaglutide's GLP-1 biology, a distinction that now dominates public attention. [29][27][4][5]
Development, dose-finding, and early cagrilintide-plus-semaglutide work positioned cagrilintide as an amylin satiety drug with a separate rationale from GLP-1 therapy before larger combination trials. [29][4][5]
Type 2 diabetes, REDEFINE, and mechanistic publications made the CagriSema program the main public evidence anchor while keeping combination results separate from cagrilintide-alone claims and informal stacking. [6][7][8][20]
34 studies
openFDA Drugs@FDA query for cagrilintide
openFDA / U.S. Food and Drug Administration. database query.
FDA's concerns with unapproved GLP-1 drugs used for weight loss
U.S. Food and Drug Administration. regulatory.
openFDA Drugs@FDA query for CagriSema
openFDA / U.S. Food and Drug Administration. database query.
Once-weekly cagrilintide for weight management in people with overweight and obesity
The Lancet. human clinical.
Cagrilintide plus semaglutide in people with overweight or obesity: a randomised phase 1b trial
The Lancet. human clinical.
Cagrilintide and semaglutide co-administration in type 2 diabetes
The Lancet. human clinical.
Coadministered cagrilintide and semaglutide in adults with overweight or obesity
New England Journal of Medicine. human clinical.
Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes
New England Journal of Medicine. human clinical.
Cagrilintide-semaglutide for weight management in east Asian individuals with overweight or obesity
Peer-reviewed clinical trial. human clinical.
REDEFINE 1 CagriSema obesity trial registry record
ClinicalTrials.gov. clinical trial registry.
REDEFINE 2 CagriSema type 2 diabetes obesity trial registry record
ClinicalTrials.gov. clinical trial registry.
Cagrilintide weight-management trial registry record
ClinicalTrials.gov. clinical trial registry.
The 2026 Prohibited List
World Anti-Doping Agency, 2025. regulatory.
Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide
Clinical pharmacokinetics, 2026. human clinical.
Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression
Diabetes, obesity & metabolism, 2026. review.
Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes
Peptides, 2026. review.
CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1
Hypertension (Dallas, Tex. : 1979), 2026. human clinical.
Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors
Acta pharmacologica Sinica, 2026. in vitro.
Characterization of 0839 - A tool compound for pre-clinical mode-of-action studies of amylin analogues such as cagrilintide
Life sciences, 2025. in vitro.
Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3
EBioMedicine, 2025. animal.
Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors
Nature communications, 2025. in vitro.
A Cross-Species Atlas of the Dorsal Vagal Complex Reveals Neural Mediators of Cagrilintide's Effects on Energy Balance
bioRxiv : the preprint server for biology, 2025. animal.
Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis
Indian journal of endocrinology and metabolism, 2024. review.
Amylin analogs for the treatment of obesity without diabetes: present and future
Expert review of clinical pharmacology, 2024. review.
Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants
Diabetes, obesity & metabolism, 2024. human clinical.
Efficacy and safety of GLP-1RAs for people with obesity: A systematic review based on RCT and Bayesian network meta-analysis
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie, 2024. review.
Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity
Cardiology in review, 2024. review.
Does receptor balance matter? - Comparing the efficacies of the dual amylin and calcitonin receptor agonists cagrilintide and KBP-336 on metabolic parameters in preclinical models
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie, 2022. animal.
Development of Cagrilintide, a Long-Acting Amylin Analogue
Journal of medicinal chemistry, 2021. in vitro.
Cagrilintide plus semaglutide for obesity management
Lancet (London, England), 2021. review.
AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors: Pharmacological Comparison with Six Selective and Nonselective Agonists
The Journal of pharmacology and experimental therapeutics, 2021. in vitro.
Emerging pharmacotherapies for obesity: A systematic review
Pharmacological reviews, 2025. review.
Weight management treatment in obesity
Medicina clinica, 2025. review.
What is the pipeline for future medications for obesity?
International journal of obesity (2005), 2025. review.