{ "schemaVersion": "2.1", "datasetVersion": "2026-09-11.1", "generatedAt": "2026-09-11", "reviewStatus": "Editorial source review is complete. This edition has not been independently medically reviewed.", "editorialBoundary": "Source-checked educational summaries. Topics require evidence and editorial review. This dataset is not a personal treatment plan.", "citation": "When you cite a record, include The Peptide Field, its canonicalPath, this dataset version, and every source used for the claim.", "reuse": "This endpoint grants no additional reuse license. Keep the verdict, scope, evidence basis, review date, and source links together. Do not present a record as medical advice or medical review.", "changeLogPath": "/corrections#correction-ledger", "contactPath": "/corrections", "dataset": "peptide-evidence-checker-record", "canonicalPath": "/peptides/cagrilintide", "canonicalUrl": "https://thepeptidefield.com/peptides/cagrilintide", "record": { "slug": "cagrilintide", "name": "Cagrilintide", "aliases": [ "NNC0174-0833", "AM833", "NN9833" ], "className": "Modified peptide based on amylin", "family": "Metabolic peptide medicines", "sequenceLabel": "37 amino acids · modified for longer action", "tier": "Emerging", "evidenceContext": "Investigational human outcomes", "statusLine": "Investigational in the United States; no FDA-approved cagrilintide product", "productContext": "Cagrilintide has been studied alone and with semaglutide. CagriSema is the investigational combination of the two molecules. Results for that combination do not automatically apply to cagrilintide alone, and the name does not prove that an online product matches study material.", "approvedProducts": [], "indications": [ "Investigational weight-management programs" ], "profile": { "humanOutcomes": { "level": "Moderate", "note": "Randomized studies measured body-weight changes in people who received cagrilintide alone or with semaglutide. Each result has its own study limits." }, "humanPharmacology": { "level": "Moderate", "note": "A small study measured cagrilintide exposure and effects in people. It studied cagrilintide only with semaglutide, so it does not describe cagrilintide alone or every population." }, "safetyKnowledge": { "level": "Limited", "note": "The reviewed studies do not define the full long-term safety profile or rare risks." }, "productCertainty": { "level": "Limited", "note": "High for the controlled material used in the studies; low for products sold outside those studies." } }, "oneLine": "An investigational peptide made to act like the body's amylin signal. Human weight-loss studies exist, but no FDA-approved product exists.", "reviewedAt": "August 30, 2026", "reviewedAtISO": "2026-08-30", "reviewHistory": [ { "date": "2026-08-30", "note": "Reviewed the cagrilintide-alone phase 2 study, the later large CagriSema study, human pharmacology, current study records, and FDA's cagrilintide statement." } ], "whatItIs": "Cagrilintide is an investigational amylin analogue. This means it is a modified peptide made to act like amylin, a body signal involved in appetite and blood-sugar control. Its chain has 37 amino acids and a fat-like side group that helps it last longer. Researchers have studied cagrilintide alone and with semaglutide. The combination is commonly called CagriSema.", "whatWeKnow": "A 26-week phase 2 study tested cagrilintide alone in adults without diabetes. It required body mass index (BMI), a height-and-weight measure, of 30 or higher. BMI 27 or higher also qualified with high blood pressure or unhealthy blood-fat levels. A later 68-week study used BMI 30 or higher, or 27 or higher with a weight-related health problem. Every group received food and activity guidance. It had separate cagrilintide, semaglutide, CagriSema, and placebo groups.", "whatWeDoNotKnow": "FDA says cagrilintide is not a component of an approved drug and has not been found safe and effective for any condition. The reviewed records do not establish a complete long-term safety profile or show that online material matches study material. A trial record shows research information. It does not prove approval or availability.", "antiDoping": null, "safetyBoundary": "An investigational molecule is not a self-treatment category. This guide does not provide trial-drug access, sourcing, dosing, injection, or combination instructions.", "relatedSlugs": [ "retatrutide", "semaglutide", "tirzepatide" ], "claims": [ { "claim": "“Cagrilintide has human weight-loss evidence in defined studies.”", "verdict": "Supported with scope", "explanation": "A phase 2 study examined cagrilintide alone. A later large study had separate cagrilintide-alone and CagriSema groups. The results apply only to each defined study group.", "category": "Clinical outcomes", "evidenceBasis": "Randomized human outcomes", "scope": "Adults without diabetes. The 26-week study required BMI 30 or higher, or BMI 27 or higher with high blood pressure or unhealthy blood-fat levels. The 68-week study required BMI 30 or higher, or BMI 27 or higher with a weight-related health problem. All groups received food and activity guidance. Each result applies only to its study group and period. The CagriSema result does not establish the same result for cagrilintide alone.", "sourceUrls": [ "https://pubmed.ncbi.nlm.nih.gov/34798060/", "https://pubmed.ncbi.nlm.nih.gov/40544433/" ] }, { "claim": "“Cagrilintide is FDA-approved.”", "verdict": "Misleading", "explanation": "FDA's current page says cagrilintide is not a component of an approved drug and has not been found safe and effective for any condition. Human research does not equal FDA approval.", "category": "Approval and status", "evidenceBasis": "Regulatory or product record", "scope": "United States regulatory status as reviewed August 30, 2026.", "sourceUrls": [ "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ] }, { "claim": "“CagriSema is cagrilintide alone.”", "verdict": "Misleading", "explanation": "CagriSema is the investigational combination of cagrilintide and semaglutide. Evidence from the combination is not evidence for cagrilintide alone.", "category": "Product equivalence", "evidenceBasis": "Randomized human outcomes", "scope": "The separate cagrilintide-alone phase 2 and later CagriSema study reviewed here.", "sourceUrls": [ "https://pubmed.ncbi.nlm.nih.gov/34798060/", "https://pubmed.ncbi.nlm.nih.gov/40544433/" ] }, { "claim": "“Cagrilintide can be compounded under federal law.”", "verdict": "Misleading", "explanation": "FDA's current unapproved-GLP-1 page says cagrilintide cannot be used in compounding under federal law. This is a United States status statement, not a finding that every online product is identical or safe.", "category": "Approval and status", "evidenceBasis": "Regulatory or product record", "scope": "United States compounding status as reviewed August 30, 2026.", "sourceUrls": [ "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ] } ], "sources": [ { "label": "Cagrilintide for weight management: randomized phase 2 trial", "publisher": "PubMed · The Lancet", "url": "https://pubmed.ncbi.nlm.nih.gov/34798060/", "kind": "Randomized trial", "year": 2021, "accessedAt": "2026-08-30" }, { "label": "Coadministered cagrilintide and semaglutide in adults with overweight or obesity", "publisher": "PubMed · New England Journal of Medicine", "url": "https://pubmed.ncbi.nlm.nih.gov/40544433/", "kind": "Randomized trial", "year": 2025, "accessedAt": "2026-08-30" }, { "label": "FDA concerns with unapproved GLP-1 drugs used for weight loss", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "kind": "Regulatory", "year": 2026, "accessedAt": "2026-08-30" }, { "label": "Cagrilintide clinical study record", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT07220642", "kind": "Trial registry", "year": 2026, "accessedAt": "2026-08-30" }, { "label": "Phase 2 cagrilintide study record (NNC0174-0833)", "publisher": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/study/NCT03856047", "kind": "Trial registry", "year": 2021, "accessedAt": "2026-08-30" }, { "label": "AM833 pharmacology and cagrilintide identity", "publisher": "PubMed · Journal of Pharmacology and Experimental Therapeutics", "url": "https://pubmed.ncbi.nlm.nih.gov/33727283/", "kind": "Preclinical", "year": 2021, "accessedAt": "2026-08-30" }, { "label": "Development of Cagrilintide, a Long-Acting Amylin Analogue", "publisher": "PubMed · Journal of Medicinal Chemistry", "url": "https://pubmed.ncbi.nlm.nih.gov/34288673/", "kind": "Preclinical", "year": 2021, "accessedAt": "2026-08-30" }, { "label": "Cagrilintide with semaglutide: human exposure and effects", "publisher": "PubMed · The Lancet", "url": "https://pubmed.ncbi.nlm.nih.gov/33894838/", "kind": "Human pharmacology", "year": 2021, "accessedAt": "2026-08-30" }, { "label": "Q2 2026 research pipeline: NN9833 is cagrilintide", "publisher": "Novo Nordisk", "url": "https://www.novonordisk.com/content/dam/nncorp/global/en/investors/pdfs/financial-results/2026/Q2-2026-Full%20presentation.pdf", "kind": "Reference", "year": 2026, "accessedAt": "2026-08-30" }, { "label": "FDA substance record: cagrilintide identity (not an approval record)", "publisher": "U.S. Food and Drug Administration", "url": "https://precision.fda.gov/ginas/app/ui/substances/AO43BIF1U8", "kind": "Reference", "year": 2026, "accessedAt": "2026-08-30" } ], "productRecords": [], "antiDopingReview": { "status": "Not assessed", "detail": "This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.", "sourceUrl": null, "reviewedAtISO": "2026-08-30" } } }