Cagrilintide/semaglutide

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Cagrilintide/semaglutide
Combination of
Cagrilintide Amylin receptor agonist
Semaglutide GLP-1 receptor agonist
Clinical data
Trade names CagriSema

Cagrilintide/semaglutide, marketed as CagriSema, is a combination of cagrilintide, a dual amylin and calcitonin receptor agonist, and semaglutide, a GLP-1 agonist. It has been proposed as a follow-on to Ozempic, Mounjaro, and Wegovy in obesity and Type II diabetes treatment. [1]

Contents

History

Developer Novo 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

CagriSema is under investigation to treat type 2 diabetes and obesity. 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 to tirzepatide. [4] [5]

Mechanism of action

UBT251 is a triple agonist – a "triple-G" medication – that targets glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. [1]

Trials

CagriSema entered Phase III clinical trials in 2023. [6] Chinese regulators approved UB251 for trial for type 2 diabetes, metabolic dysfunction-associated fatty liver disease and chronic 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

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

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

  1. 1 2 3 4 5 Thompson, Bronwyn (2025-03-25). "Next-gen weight-loss drugs will be here within 12 months". New Atlas. Retrieved 2025-04-05.
  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. 1 2 "News Details". Novo Nordisk. Retrieved 2025-06-25.
  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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