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

78% Moderate

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]

Human evidence

CagriSema studies show larger weight-loss effects when cagrilintide is coadministered with semaglutide in adults with overweight or obesity. [5][7][9]

Animal / mechanistic evidence

The rationale combines amylin/calcitonin receptor signaling from cagrilintide with GLP-1 receptor signaling from semaglutide. [18][20][16]

Monotherapy weight reduction

Injectable

70% Moderate

Cagrilintide monotherapy has human weight-management evidence, while the largest effects currently come from the semaglutide combination program. [4][15][1]

Human evidence

A phase 2 dose-finding study supports once-weekly cagrilintide monotherapy for body-weight reduction in people with overweight or obesity. [4][12]

Animal / mechanistic evidence

Amylin analog activity supports satiety and energy-balance biology, complementing but not requiring GLP-1 pathway biology. [20][18][31]

Type 2 diabetes glycemic control

Injectable

66% Moderate

Type 2 diabetes glycemic control is a CagriSema combination use case, not evidence that cagrilintide alone is an approved diabetes therapy. [8][1]

Human evidence

CagriSema has human trial evidence in type 2 diabetes with obesity or overweight, including weight and glycemic endpoints. [6][8]

Animal / mechanistic evidence

The glycemic component is strongly influenced by semaglutide, so this should be read as combination evidence. [6]

Appetite control and satiety

Injectable

49% Preliminary

Satiety is a plausible cagrilintide effect within weight management, but it should not be framed as a standalone approved use. [4][16]

Human evidence

Human weight-management studies are consistent with a satiety-driven effect, but they mainly report body-weight change rather than direct day-to-day appetite endpoints. [4][5]

Animal / mechanistic evidence

Mechanistic studies link cagrilintide to amylin and calcitonin receptor pathways, including brain amylin receptor signaling involved in energy balance. [20][18][31]

Evidence snapshot

Overall confidence

Strong

82%

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.

82%

Human evidence

Strong

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]

68%

Animal / preclinical

Moderate

Preclinical and receptor-mechanism research supports amylin and calcitonin receptor biology, but the practical confidence comes from human weight-management trials. [31][20][18]

80%

Mechanism support

Strong

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]

Injectable

Dosing & protocols

These ranges are general reference points, not personal dosing instructions.

Typical Range

Doses range from 0.3-4.5 mg once weekly. Combination protocols use 2.4 mg cagrilintide with 2.4 mg semaglutide. [4][5][7][8]

Frequency

Taken once weekly by subcutaneous injection. [4][5][10][11]

Timing Considerations

Use the same injection day each week. [4][5][10]

Cycle Length

Treatment is long term, commonly lasting 6-16 months. [4][10][11][7]

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]

Common side effects

Nausea [4]
Vomiting [5][7]
Diarrhea [5][7]

Cautions

No FDA label [1][3]
Semaglutide, GLP-1, or other satiety drugs [5][7]
Pregnancy and special populations [10][1]

What we don't know

Rare events, long-term use, discontinuation effects, and special-population safety remain unsettled while cagrilintide and CagriSema development continues. [10][11]

Who Cagrilintide is not for

Route-specific avoid and medical-review notes:

Pregnancy and special populations
Until approved labeling exists, pregnancy, breastfeeding, pediatric use, frailty, and complex endocrine disease should be treated as trial-exclusion-level concerns. [10][1]

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

Semaglutide as GLP-1 partner Injectable

Semaglutide activates GLP-1 pathways that reduce appetite and slow gastric emptying, while cagrilintide activates amylin pathways that increase satiety. Together they provide complementary appetite-control signals. [5][7]

Not recommended with

Additional GLP-1/GIP/amylin agents beyond studied CagriSema Injectable

Cagrilintide's established combination context is the once-weekly CagriSema regimen with semaglutide. Adding tirzepatide, retatrutide, another GLP-1 receptor agonist, or another amylin agent introduces additional appetite, gastric-emptying, and glucose effects outside that regimen. Semaglutide and tirzepatide should not be used with another GLP-1 receptor agonist. [7][8][35][36]

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 Approved

Cagrilintide and CagriSema are not FDA-approved for human use as drug products in the United States. [1][3][2]

503A compounding

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]

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:

Regulatory review and approved labeling are still needed to define safe dosing, warnings, contraindications, manufacturing standards, and real-world use. [1][3]

Trials need to separate cagrilintide's effects from semaglutide's effects; results from CagriSema should not be treated as proof for cagrilintide alone. [4][7]

Longer studies should show what happens during maintenance and after stopping, including changes in muscle mass and risks involving the gut, gallbladder, diabetes medications, and understudied populations. [10][11]

Common questions

Is cagrilintide a GLP-1 drug?

No. Cagrilintide is an amylin analog. It is often discussed with semaglutide because CagriSema combines amylin and GLP-1 pathways. [4][5]

Is CagriSema FDA-approved?

No. CagriSema is not FDA-approved for human use as a drug product in the United States. [3][2]

Can CagriSema results be used as cagrilintide-alone results?

No. CagriSema includes semaglutide, so the efficacy and safety profile belongs to the combination. [7][8]

Myths & misconceptions

Myth

Amylin analogs and GLP-1 agonists are the same kind of peptide.

Reality

They are both satiety-related metabolic therapies, but they target different hormone pathways. [4][5]

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]

Published research 34 studies

[1]

openFDA Drugs@FDA query for cagrilintide

openFDA / U.S. Food and Drug Administration. database query.

[2]

FDA's concerns with unapproved GLP-1 drugs used for weight loss

U.S. Food and Drug Administration. regulatory.

[3]

openFDA Drugs@FDA query for CagriSema

openFDA / U.S. Food and Drug Administration. database query.

[4]

Once-weekly cagrilintide for weight management in people with overweight and obesity

The Lancet. human clinical.

[5]

Cagrilintide plus semaglutide in people with overweight or obesity: a randomised phase 1b trial

The Lancet. human clinical.

[6]

Cagrilintide and semaglutide co-administration in type 2 diabetes

The Lancet. human clinical.

[7]

Coadministered cagrilintide and semaglutide in adults with overweight or obesity

New England Journal of Medicine. human clinical.

[8]

Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes

New England Journal of Medicine. human clinical.

[9]

Cagrilintide-semaglutide for weight management in east Asian individuals with overweight or obesity

Peer-reviewed clinical trial. human clinical.

[10]

REDEFINE 1 CagriSema obesity trial registry record

ClinicalTrials.gov. clinical trial registry.

[11]

REDEFINE 2 CagriSema type 2 diabetes obesity trial registry record

ClinicalTrials.gov. clinical trial registry.

[12]

Cagrilintide weight-management trial registry record

ClinicalTrials.gov. clinical trial registry.

[13]

The 2026 Prohibited List

World Anti-Doping Agency, 2025. regulatory.

[14]

Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide

Clinical pharmacokinetics, 2026. human clinical.

[15]

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.

[16]

Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes

Peptides, 2026. review.

[17]

CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1

Hypertension (Dallas, Tex. : 1979), 2026. human clinical.

[18]

Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors

Acta pharmacologica Sinica, 2026. in vitro.

[19]

Characterization of 0839 - A tool compound for pre-clinical mode-of-action studies of amylin analogues such as cagrilintide

Life sciences, 2025. in vitro.

[20]

Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3

EBioMedicine, 2025. animal.

[21]

Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors

Nature communications, 2025. in vitro.

[22]

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.

[23]

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.

[24]

Amylin analogs for the treatment of obesity without diabetes: present and future

Expert review of clinical pharmacology, 2024. review.

[25]

Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants

Diabetes, obesity & metabolism, 2024. human clinical.

[26]

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.

[27]

Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity

Cardiology in review, 2024. review.

[28]

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.

[29]

Development of Cagrilintide, a Long-Acting Amylin Analogue

Journal of medicinal chemistry, 2021. in vitro.

[30]

Cagrilintide plus semaglutide for obesity management

Lancet (London, England), 2021. review.

[31]

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.

[32]

Emerging pharmacotherapies for obesity: A systematic review

Pharmacological reviews, 2025. review.

[33]

Weight management treatment in obesity

Medicina clinica, 2025. review.

[34]

What is the pipeline for future medications for obesity?

International journal of obesity (2005), 2025. review.