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Cagrilintide/semaglutide

From Wikipedia, the free encyclopedia
Combination drug
Pharmaceutical compound
Cagrilintide/semaglutide
Combination of
CagrilintideAmylin receptor agonist
SemaglutideGLP-1 receptor agonist
Clinical data
Trade namesCagriSema

Cagrilintide/semaglutide, marketed asCagriSema, is a combination ofcagrilintide, adual amylin and calcitonin receptor agonist, andsemaglutide, aGLP-1 agonist. It has been proposed as a follow-on to Ozempic,Mounjaro, andWegovy inobesity andType II diabetes treatment.[1]

History

[edit]

DeveloperNovo Nordisk concluded a US$2-billion deal with Chinese pharmaceutical company United Biotechnology to license its drug for delivery outside of China/Hong Kong/Macau/Taiwan. United Biotechnology was expected to get an initial $200 million payment followed by up to $1.8 billion and tiered royalties.[1]

Rival Eli Lilly finished its Phase III trials on its own "triple-G" drug,retatrutide, also for diabetes and obesity.[1]

Applications

[edit]

CagriSema is under investigation to treattype 2 diabetes andobesity. Preliminary trial results found a greater weight loss compared to either semaglutide or cagrilintide alone.HbA1c was significantly improved compared to cagrilintide alone and non-significantly better than semaglutide alone.[2][3] In a Phase II trial, weight loss averaged -15.6 percent after 32 weeks, comparable in efficacy totirzepatide.[4][5]

Trials

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CagriSema enteredPhase III clinical trials in 2023.[6] Chinese regulators approved UB251 for trial for type 2 diabetes, metabolic dysfunction-associatedfatty liver disease andchronic kidney disease. In a small Phase II trial in China, the drug was associated with an average 15.1% weight loss over 12 weeks.[1]

REDEFINE 1

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In June 2025, results were published in the New England Journal of Medicine on REDEFINE 1, a 68-week, double-blind, Phase III clinical trial enrolling 3,417 participants, testing weekly cagrilintide 2.4 mg and semaglutide 2.4 mg individually and together versus placebo in obese/overweight subjects with comorbidities. People treated with CagriSema lost 20.4% of their body weight over 68 weeks, versus 11.5% with cagrilintide 2.4 mg alone, 14.9% with semaglutide 2.4 mg alone, and 3.0% with placebo.[7][8]

REDEFINE 2

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In June 2025, results were published in the New England Journal of Medicine on REDEFINE 2, a 68-week, double-blind, Phase III clinical trial enrolling 1,206 participants. REDEFINE 2 reported that obese or overweight adult patients with type 2 diabetes lost 13.7% of their weight over 68 weeks with Cagrilintide/semaglutide, compared with 3.1% with placebo.[9][8]

References

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  1. ^abcdThompson, Bronwyn (2025-03-25)."Next-gen weight-loss drugs will be here within 12 months".New Atlas. Retrieved2025-04-05.
  2. ^Enebo, Lone B; Berthelsen, Kasper K; Kankam, Martin; Lund, Michael T; Rubino, Domenica M; Satylganova, Altynai; Lau, David C W (May 2021)."Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial".The Lancet.397 (10286):1736–1748.doi:10.1016/S0140-6736(21)00845-X.PMID 33894838.S2CID 233354744.
  3. ^Frias, Juan P; Deenadayalan, Srikanth; Erichsen, Lars; Knop, Filip K; Lingvay, Ildiko; Macura, Stanislava; Mathieu, Chantal; Pedersen, Sue D; Davies, Melanie (August 2023). "Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial".The Lancet.402 (10403):720–730.doi:10.1016/S0140-6736(23)01163-7.PMID 37364590.S2CID 259237278.
  4. ^Idris, Iskandar (July 2023)."Coadministration of the long-acting amylin analog cagrilintide plus semaglutide ( CagriSema ), resulted in significantly greater weight loss, along with improved measures of glucose control, in a short phase 2 trial of patients with type 2 diabetes".Diabetes, Obesity and Metabolism Now.1 (7).doi:10.1002/doi2.68.ISSN 2688-8939.
  5. ^Holst, Jens Juul; Jepsen, Sara Lind; Modvig, Ida (April 2022)."GLP-1 – Incretin and pleiotropic hormone with pharmacotherapy potential. Increasing secretion of endogenous GLP-1 for diabetes and obesity therapy".Current Opinion in Pharmacology.63 102189.doi:10.1016/j.coph.2022.102189.PMID 35231672.
  6. ^Jeon, Eonju; Lee, Ki Young; Kim, Kyoung-Kon (1 June 2023)."Approved Anti-Obesity Medications in 2022 KSSO Guidelines and the Promise of Phase 3 Clinical Trials: Anti-Obesity Drugs in the Sky and on the Horizon".Journal of Obesity & Metabolic Syndrome.32 (2):106–120.doi:10.7570/jomes23032.ISSN 2508-7576.PMC 10327684.PMID 37349257.
  7. ^Garvey, W. Timothy; Blüher, Matthias; Contreras, Cynthia Karenina Osorto; Davies, Melanie J.; Lehmann, Eva Winning; Pietiläinen, Kirsi H.; Rubino, Domenica; Sbraccia, Paolo; Wadden, Thomas; Zeuthen, Niels; Wilding, John P. H. (2025)."Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity".New England Journal of Medicine.0.doi:10.1056/NEJMoa2502081.ISSN 0028-4793.PMID 40544433.
  8. ^ab"News Details".Novo Nordisk. Retrieved2025-06-25.
  9. ^Davies, Melanie J.; Bajaj, Harpreet S.; Broholm, Christa; Eliasen, Astrid; Garvey, W. Timothy; Roux, Carel W. le; Lingvay, Ildiko; Lyndgaard, Christian Bøge; Rosenstock, Julio; Pedersen, Sue D. (2025)."Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes".New England Journal of Medicine.0.doi:10.1056/NEJMoa2502082.ISSN 0028-4793.PMID 40544432.


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