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 is injected once weekly and is being tested in type 2 diabetes and obesity. Preliminary trial results found a greater weight loss compared to either medication alone. HbA1c was significantly improved compared to cagrilintide alone and non-significantly better than semaglutide alone. [1] [2] In a Phase II trial, weight loss averaged -15.6 percent after 32 weeks, making CagriSema comparable in efficacy to tirzepatide. [3] [4] A future trial sponsored by Novo Nordisk is comparing tirzepatide and CagriSema head-to-head. [5]

Contents

Clinical Trials

CagriSema entered Phase III clinical trials in 2023. [6]

REDEFINE 1

In December 2024, Novo Nordisk announced the results of REDEFINE 1, one of their series of Phase III trials, testing weekly cagrilintide 2.4 mg and semaglutide 2.4 mg individually and together versus placebo in obese or overweight subjects with one or more comorbidities. [7] In the intention-to-treat analysis, 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]

REDEFINE-2

In March 2025, results from the REDEFINE-2 late stage clinical trial showed the combination helped obese or overweight adult patients with type 2 diabetes lose 15.7% of their weight over 68 weeks, compared with 3.1% with placebo. [8]

References

  1. ↑ 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.
  2. ↑ 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.
  3. ↑ 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.
  4. ↑ 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.
  5. ↑ "CTG Labs - NCBI". clinicaltrials.gov. Retrieved 5 December 2023.
  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. 1 2 "Novo Nordisk A/S: CagriSema demonstrates superior weight loss in adults with obesity or overweight in the REDEFINE 1 trial". Novo Nordisk. December 20, 2024. Retrieved 1 January 2025.
  8. ↑ Taylor, Chloe (2025-03-10). "Novo Nordisk shares fall 6.3% after latest trial results for its next-generation weight loss drug". CNBC. Retrieved 2025-03-24.


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