Cagrilintide
Investigational in the United States; no FDA-approved cagrilintide product or prescribing information exists.
Current sourceCagrilintide
Human trial results do not make cagrilintide an FDA-approved or compoundable drug
Cagrilintide is a long-acting amylin analogue under investigation for weight management, alone and with semaglutide as CagriSema. It is not an FDA-approved drug. FDA states that cagrilintide is not a component of an FDA-approved drug, has not been found safe and effective for any condition, and cannot be used in compounding under federal law. Trial results apply to sponsor-controlled investigational products and defined populations, not products sold online under the same name.
Editorial status
This page aggregates regulatory documents and published human research. Its claims, citations, populations, and limitations received an independent editorial evidence check. Last editorial audit: .
It has not been medically reviewed by a clinician. It provides general education, not diagnosis, treatment, dosing instructions, or advice for an individual. Use the product-specific official information and consult a qualified clinician or pharmacist for personal decisions.
Product and regulatory distinctions
A compound name is not one interchangeable set of instructions. Product, formulation, indication, labeling, and jurisdiction matter.
Compounded or online products marketed as cagrilintide
FDA states that cagrilintide cannot be used in compounding under federal law and is not a component of an FDA-approved drug. A seller's label does not establish identity, quality, safety, efficacy, or equivalence to clinical-trial material.
Current sourceCagriSema (cagrilintide plus semaglutide)
An investigational co-formulation studied in phase 3 trials; published trial results are not FDA approval.
Current sourceClaim-by-claim evidence map
Each finding is tied to the population and product actually studied. Trial results are not personal predictions.
Cagrilintide alone produced dose-related weight reduction in a phase 2 trial.
- Population
- 906 adults without diabetes who had obesity, or overweight with hypertension or dyslipidemia, in a 26-week randomized dose-finding trial across ten countries.
- Finding
- Under the trial-product estimand, mean weight reductions ranged from 6.0% to 10.8% across cagrilintide groups, compared with 3.0% for pooled placebo.
- Limits
- This sponsor-funded phase 2 study was dose-finding and relatively short. It does not establish FDA approval, long-term benefit-risk, individual outcomes, or equivalence of products outside the trial.
Cagrilintide-semaglutide produced greater mean weight reduction than either component in a phase 3 obesity trial.
- Population
- Adults without diabetes who had obesity, or overweight with at least one obesity-related complication, in a 68-week phase 3a trial.
- Finding
- The published REDEFINE 1 trial found greater mean weight reduction with the investigational combination than with cagrilintide alone, semaglutide alone, or placebo.
- Limits
- The result is for a defined investigational combination, population, protocol, and trial estimand. It does not establish approval or support substituting separately sourced or seller-mixed products.
A small phase 2 trial in type 2 diabetes found different glycemic and weight effects for the combination and its individual components.
- Population
- 92 adults with type 2 diabetes and BMI of at least 27 kg/m² receiving metformin with or without an SGLT2 inhibitor in a 32-week randomized trial.
- Finding
- Mean HbA1c change was -2.2 percentage points with CagriSema, -1.8 with semaglutide, and -0.9 with cagrilintide; mean weight change was -15.6%, -5.1%, and -8.1%, respectively.
- Limits
- The trial was small, sponsor-funded, and not designed to establish long-term cardiovascular outcomes or the safety and efficacy of non-trial products.
Gastrointestinal events were common in cagrilintide clinical trials.
- Population
- Participants in the phase 2 weight-management and type 2 diabetes trials.
- Finding
- The weight-management trial identified gastrointestinal disorders and administration-site reactions as the most frequent adverse events; the diabetes trial reported mostly mild or moderate gastrointestinal events.
- Limits
- Clinical development data cannot exclude uncommon, delayed, combination-specific, or population-specific harms, and cannot characterize product-quality risks outside regulated trials.
What this evidence does not answer
- No FDA-approved label defines an indication, contraindications, warnings, manufacturing controls, or postmarketing safety for cagrilintide or CagriSema.
- Long-term cardiovascular and other clinical outcomes require completed trials and regulatory review; weight change alone does not establish overall benefit-risk.
- Trial publications do not validate the identity, sterility, purity, strength, stability, or safety of products sold as cagrilintide or as seller-prepared combinations.
- Evidence for cagrilintide alone is less extensive than the emerging evidence for its investigational combination with semaglutide.
Useful information to organize between visits
- Whether access is through a registered clinical trial and the exact trial identifier
- The exact investigational product and sponsor documentation—not only a seller's use of the name cagrilintide
- Study visits, symptoms, and laboratory results recorded through the research team
- Every medicine, supplement, and experimental product disclosed to trial investigators
- Regulatory-status changes checked against FDA sources rather than marketing claims
Questions to bring to a clinician or pharmacist
- 1.Is there a registered cagrilintide or CagriSema trial for which I might qualify?
- 2.Which FDA-approved options currently have evidence for my condition?
- 3.How does an investigational product differ from a compounded or online product using the same name?
- 4.What should a clinical-trial participant report promptly to the study team?
Primary sources
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration · Published 2026 · Accessed July 12, 2026
- Once-weekly cagrilintide for weight management in people with overweight and obesity: a phase 2 trialThe Lancet via PubMed · Published 2021 · Accessed July 12, 2026
- Cagrilintide with semaglutide in type 2 diabetes: a phase 2 trialThe Lancet via PubMed · Published 2023 · Accessed July 12, 2026
- Coadministered Cagrilintide and Semaglutide in Adults with Overweight or ObesityThe New England Journal of Medicine via PubMed · Published 2025 · Accessed July 12, 2026
- REDEFINE 1: Cagrilintide and semaglutide in adults with overweight or obesityClinicalTrials.gov · Published 2022 · Accessed July 12, 2026
- Investigation of safety and efficacy of cagrilintide for weight managementClinicalTrials.gov · Published 2019 · Accessed July 12, 2026
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