# CagriSema CagriSema is investigational: it is still in clinical trials, and FDA has not approved it. It combines cagrilintide with semaglutide. Its maker has asked FDA for approval, which is not the same as approval. The evidence grade is moderate-human for weight loss. Pharmacies may not make it. Status checked: 2026-10-25. Last verified: 2026-10-25. Primary source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | cagrilintide and semaglutide, cagrilintide-semaglutide | peer-reviewed | 2026-10-25 | [source](https://pubmed.ncbi.nlm.nih.gov/40544432/) | | Class | amylin-analog | peer-reviewed | 2026-10-25 | [source](https://pubmed.ncbi.nlm.nih.gov/42838477/) | | Regulatory status | investigational | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) | | Status source read | 2026-10-24 | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026) | | Evidence grade | moderate-human | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) | ## Name CagriSema Source: https://pubmed.ncbi.nlm.nih.gov/42838477/ ## Summary A weekly test shot that joins two drugs: cagrilintide, a copy of the hormone amylin, and the GLP-1 drug semaglutide. It is not approved. Source: https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema ## Short answer CagriSema is investigational: it is still in clinical trials, and FDA has not approved it. It combines cagrilintide with semaglutide. Its maker has asked FDA for approval, which is not the same as approval. The evidence grade is moderate-human for weight loss. Pharmacies may not make it. Source: https://peptideindex.ai/methodology#short-answer ## Known risks - In a 68-week trial of adults without diabetes, about 8 in 10 people on it had stomach or gut problems. On a dummy shot, about 4 in 10 did [^13]. - Those problems included nausea, vomiting, diarrhea, constipation and belly pain. Most were mild or moderate and went away [^13] [^14]. - A 2026 review of five trials found skin reactions where the shot goes in. They were about three times as common as on semaglutide alone [^18]. - Products sold online as cagrilintide are unapproved new drugs. FDA says shots skip some of the body's defenses, so germs or toxins in them can cause life-threatening illness [^6]. - FDA says unapproved GLP-1 products sold online may be fake, may hold the wrong ingredient, or may hold too much or too little [^1]. Source: https://pubmed.ncbi.nlm.nih.gov/40544433/ ## What nobody knows yet - Nobody knows yet whether it prevents heart attacks, strokes or heart deaths. A trial of about 7,000 people with heart disease is still running [^9] [^17]. - The longest published trials lasted 68 weeks. Nobody knows what years of use do to the body [^13] [^14] [^18]. - A 2026 review could not tell if serious harms or cancers are more common than on semaglutide alone. There is too little data [^18]. - Nobody knows if or when FDA will approve it. Its maker asked for approval in December 2025 [^20] [^19]. - Nobody can tell what is in cagrilintide sold online. No trial has tested those products, and they are not the drug used in trials [^6]. Source: https://pubmed.ncbi.nlm.nih.gov/42890523/ ## What it is CagriSema is an experimental drug given as a weekly shot under the skin [^17]. It joins two drugs in one shot [^17]. Cagrilintide is a long-acting copy of the hormone amylin [^15] [^17]. Semaglutide is a GLP-1 drug [^15]. Together they lead to weight loss [^15]. Semaglutide on its own is an approved drug, and it has its own page on this site. Cagrilintide is not part of any approved drug [^1]. One drug company makes CagriSema and has paid for its large trials [^13] [^14] [^17]. It is not sold in any pharmacy, and FDA has not approved it for any condition [^1] [^2]. Source: https://pubmed.ncbi.nlm.nih.gov/42838477/ ## Where it stands legally CagriSema is investigational: it is being tested in clinical trials, and FDA has not approved it for any use [^1] [^2]. Its maker has asked FDA to approve it, and that request is not an approval [^20]. It also does not let pharmacies make it. Checked 24 October 2026. FDA keeps a list of new drugs it approved in 2026. That list, current to 20 October 2026, does not include CagriSema or cagrilintide [^2]. The maker filed its request in December 2025 [^20]. A news report in February 2026 said a decision was expected late in 2026 [^19]. It is being studied for weight loss in people with obesity, with or without type 2 diabetes, and in people with heart disease [^7] [^8] [^9]. Online, cagrilintide on its own is sold for weight loss, labeled for research only [^6]. Under federal law, pharmacies may not use cagrilintide to make drugs [^1] [^12]. It is not part of any approved drug [^1]. It is also not on either of FDA's lists of raw ingredients for pharmacies [^4] [^5]. A pharmacy may use a raw ingredient on only three bases [^3]. It meets an official quality standard, it is part of an approved drug, or it is on FDA's 503A bulks list [^3]. A research-use label does not change this. FDA treats such a product as an unapproved new drug when its seller shows it is meant for people [^6]. Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss ## What the evidence shows The evidence grade is moderate-human: large trials in people show more weight loss than a dummy shot [^13] [^14]. None has yet shown fewer heart attacks, and the maker paid for them [^17]. In a 68-week trial of 3,417 adults without diabetes, weight fell by about 20%. On a dummy shot it fell by about 3% [^13]. In a 68-week trial of 1,206 adults with type 2 diabetes, weight fell by about 14%, against about 3% on a dummy shot [^14]. Some trials compared it with semaglutide alone. In a 32-week US trial of 92 adults with type 2 diabetes, weight fell by about 16%. On semaglutide alone it fell by 5% [^15]. HbA1c, a blood test of average blood sugar, fell by about the same amount in both groups [^15]. In a 68-week trial of 331 adults in Japan and Taiwan, weight fell by about 18%, against 12% on semaglutide alone [^16]. A 2026 review of five trials found about 7 points more weight loss than semaglutide alone. It found no added effect on blood sugar [^18]. In a trial against tirzepatide, another approved drug, CagriSema led to slightly less weight loss after 84 weeks [^10] [^19]. A heart trial of 7,076 adults with heart disease has not reported results yet [^9] [^17]. These trials tested the maker's own combined drug. They tell us nothing about cagrilintide sold online, which is a different product [^6]. Source: https://pubmed.ncbi.nlm.nih.gov/40544433/ ## Legitimate ways to get it The only legal way to get CagriSema in the US is to join a clinical trial [^1] [^11]. No approved product exists, and no pharmacy may lawfully make it [^1] [^2]. On 24 October 2026 this page checked one registry record of a CagriSema study open to new people [^11]. It compares two strengths of CagriSema with semaglutide in adults with obesity [^11]. Its US sites in five states were listed as not yet recruiting [^11]. Each trial has strict rules on who may join. Source: https://clinicaltrials.gov/study/NCT07564414 ## How people are getting it anyway This section describes what happens and is not a recommendation. No FDA page we found names CagriSema itself in a warning letter. What reaches people outside trials is cagrilintide on its own, one of the two parts [^6]. It is sold online labeled for research use [^6]. In March 2026 FDA sent a warning letter to one such seller. It said the products were unapproved new drugs, whatever the label said [^6]. Some people may look for cagrilintide as a compounded drug. Federal law does not allow it in compounding [^1] [^12]. FDA does not check compounded drugs for quality before they are sold [^1]. In each case, nobody checks what is in the vial [^1]. FDA warns that unapproved GLP-1 products sold online may be fake or hold the wrong amount of drug [^1]. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026 ## Access routes Source: https://clinicaltrials.gov/study/NCT07564414 ### Clinical trial Detail: CagriSema is only available inside clinical trials. On 24 October 2026 this page checked one registry record of a study open to new people. Its US sites were not yet recruiting. Source: https://clinicaltrials.gov/study/NCT07564414 ## Unofficial channels Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss ### Research use seller What it is: Cagrilintide on its own, one of the two parts of CagriSema, sold online labeled for research use. Legal position: FDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026) Documented risks: - FDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026) - FDA says cagrilintide has not been found to meet its standards for any condition and is not part of any approved drug. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) Enforcement: - 2026-03-31: FDA warning letter to an online seller of research-use cagrilintide. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026 ### Compounding outside the rules What it is: Cagrilintide offered as a compounded drug, mixed by a pharmacy from raw ingredient. Legal position: Cagrilintide cannot be used in compounding under federal law. It is not part of any approved drug. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) Documented risks: - FDA does not check compounded drugs for quality, or for whether they help, before they are sold. (source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss ## Recruiting trials Snapshot date: 2026-10-25. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. - nct NCT07817251, url https://clinicaltrials.gov/study/NCT07817251, phase Phase 3, title Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema, status recruiting, sponsor Novo Nordisk A/S, countries United States, us states Arizona, California, Connecticut, Florida, Hawaii, Illinois, Iowa, Kansas, Michigan, Nevada, New Mexico, North Carolina, Ohio, Tennessee, Texas, Utah, Virginia - nct NCT07745504, url https://clinicaltrials.gov/study/NCT07745504, phase Phase 3, title A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight, status recruiting, sponsor Novo Nordisk A/S, countries United States, Greece, Hungary, Portugal, Serbia, Sweden, us states Georgia, Hawaii, Illinois, Indiana, Kentucky, North Carolina, South Carolina, Virginia - nct NCT07282613, url https://clinicaltrials.gov/study/NCT07282613, phase Phase 3, title 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 recruiting, sponsor Novo Nordisk A/S, countries United States, Argentina, Brazil, Colombia, India, Israel, Malaysia, Mexico, Taiwan, Thailand, us states Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Michigan, New York, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington - nct NCT07564414, url https://clinicaltrials.gov/study/NCT07564414, phase Phase 3, title A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight, status recruiting, sponsor Novo Nordisk A/S, countries United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, us states Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin - nct NCT07597018, url https://clinicaltrials.gov/study/NCT07597018, phase Phase 1, title 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, sponsor Novo Nordisk A/S, countries Germany, us states none listed - nct NCT07527195, url https://clinicaltrials.gov/study/NCT07527195, phase Phase 1, title Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health), status recruiting, sponsor Novo Nordisk A/S, countries Denmark, us states none listed - nct NCT07253285, url https://clinicaltrials.gov/study/NCT07253285, phase Phase 3, title A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight, status recruiting, sponsor Novo Nordisk A/S, countries United States, Australia, Austria, Belgium, Bulgaria, China, Colombia, Croatia, Denmark, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Taiwan, Thailand, United Kingdom, us states California, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maryland, Minnesota, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah - nct NCT07010432, url https://clinicaltrials.gov/study/NCT07010432, phase Phase 1, title The Role of the Amylin Analogue Cagrilintide in Bone Metabolism, status recruiting, sponsor Novo Nordisk A/S, countries Denmark, us states none listed Source: https://clinicaltrials.gov/api/v2/studies?query.intr=CagriSema+OR+cagrilintide+semaglutide&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState ## Sources Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss ### 1. FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss ### 2. FDA: novel drug approvals for 2026, current to 20 October 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026 ### 3. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 4. FDA: bulk drug substances that may present significant safety risks (Category 2) Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### 5. FDA: 503A bulk drug substance categories list Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 6. FDA warning letter to an online seller of research-use cagrilintide, 31 March 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026 ### 7. ClinicalTrials.gov NCT05567796: REDEFINE 1, obesity without diabetes Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT05567796 ### 8. ClinicalTrials.gov NCT05394519: REDEFINE 2, obesity with type 2 diabetes Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT05394519 ### 9. ClinicalTrials.gov NCT05669755: REDEFINE 3, heart outcomes Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT05669755 ### 10. ClinicalTrials.gov NCT06131437: REDEFINE 4, against tirzepatide Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT06131437 ### 11. ClinicalTrials.gov NCT07564414: two strengths of CagriSema against semaglutide Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT07564414 ### 12. Venable: FDA's latest GLP-1 enforcement, 13 March 2026 Type: legal-analysis Tier: legal-analysis Source: https://www.venable.com/insights/publications/2026/03/fdas-latest-glp-1-crackdown-what-compounders ### 13. REDEFINE 1: CagriSema in adults with overweight or obesity, 2025 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/40544433/ ### 14. REDEFINE 2: CagriSema in adults with obesity and type 2 diabetes, 2025 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/40544432/ ### 15. Phase 2 trial of CagriSema in type 2 diabetes, 2023 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/37364590/ ### 16. REDEFINE 5: CagriSema against semaglutide alone in Japan and Taiwan, 2026 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/42009015/ ### 17. Design and baseline of the CagriSema heart outcomes trial, REDEFINE 3, 2026 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/42838477/ ### 18. Review of trials of CagriSema against semaglutide alone, 2026 Type: systematic-review Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/42890523/ ### 19. CNBC: CagriSema after its trial against tirzepatide, 24 February 2026 Type: reference Tier: established-news Source: https://www.cnbc.com/2026/02/24/healthy-returns-whats-next-for-novo-nordisks-obesity-drug-cagrisema.html ### 20. Pharmaceutical Executive: the maker asks FDA to approve CagriSema, 18 December 2025 Type: reference Tier: established-news Source: https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema Last verified: 2026-10-25. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=CagriSema+OR+cagrilintide+semaglutide&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState - https://clinicaltrials.gov/study/NCT07564414 - https://peptideindex.ai/methodology#evidence-grade - https://peptideindex.ai/methodology#short-answer - https://pubmed.ncbi.nlm.nih.gov/40544432/ - https://pubmed.ncbi.nlm.nih.gov/40544433/ - https://pubmed.ncbi.nlm.nih.gov/42838477/ - https://pubmed.ncbi.nlm.nih.gov/42890523/ - https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss - https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026 - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026 - https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema [^1]: FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss [^2]: FDA: novel drug approvals for 2026, current to 20 October 2026 https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026 [^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^4]: FDA: bulk drug substances that may present significant safety risks (Category 2) https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [^5]: FDA: 503A bulk drug substance categories list https://www.fda.gov/media/94155/download [^6]: FDA warning letter to an online seller of research-use cagrilintide, 31 March 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026 [^7]: ClinicalTrials.gov NCT05567796: REDEFINE 1, obesity without diabetes https://clinicaltrials.gov/study/NCT05567796 [^8]: ClinicalTrials.gov NCT05394519: REDEFINE 2, obesity with type 2 diabetes https://clinicaltrials.gov/study/NCT05394519 [^9]: ClinicalTrials.gov NCT05669755: REDEFINE 3, heart outcomes https://clinicaltrials.gov/study/NCT05669755 [^10]: ClinicalTrials.gov NCT06131437: REDEFINE 4, against tirzepatide https://clinicaltrials.gov/study/NCT06131437 [^11]: ClinicalTrials.gov NCT07564414: two strengths of CagriSema against semaglutide https://clinicaltrials.gov/study/NCT07564414 [^12]: Venable: FDA's latest GLP-1 enforcement, 13 March 2026 https://www.venable.com/insights/publications/2026/03/fdas-latest-glp-1-crackdown-what-compounders [^13]: REDEFINE 1: CagriSema in adults with overweight or obesity, 2025 https://pubmed.ncbi.nlm.nih.gov/40544433/ [^14]: REDEFINE 2: CagriSema in adults with obesity and type 2 diabetes, 2025 https://pubmed.ncbi.nlm.nih.gov/40544432/ [^15]: Phase 2 trial of CagriSema in type 2 diabetes, 2023 https://pubmed.ncbi.nlm.nih.gov/37364590/ [^16]: REDEFINE 5: CagriSema against semaglutide alone in Japan and Taiwan, 2026 https://pubmed.ncbi.nlm.nih.gov/42009015/ [^17]: Design and baseline of the CagriSema heart outcomes trial, REDEFINE 3, 2026 https://pubmed.ncbi.nlm.nih.gov/42838477/ [^18]: Review of trials of CagriSema against semaglutide alone, 2026 https://pubmed.ncbi.nlm.nih.gov/42890523/ [^19]: CNBC: CagriSema after its trial against tirzepatide, 24 February 2026 https://www.cnbc.com/2026/02/24/healthy-returns-whats-next-for-novo-nordisks-obesity-drug-cagrisema.html [^20]: Pharmaceutical Executive: the maker asks FDA to approve CagriSema, 18 December 2025 https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema