Survodutide for the treatment of obesity: rationale and design of the SYNCHRONIZE cardiovascular outcomes trial : methodology and mechanisms corner
Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors may be more effective than GLP-1 receptor agonism alone in reducing body weight, but the cardiovascular (CV) effects are unknown. The authors describe the rationale and design of SYNCHRONIZE-CVOT, a phase 3, randomized, double-bl...
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| Main Authors: | , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
December 2024
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| In: |
JACC Heart failure
Year: 2024, Volume: 12, Issue: 12, Pages: 2101-2109 |
| ISSN: | 2213-1787 |
| DOI: | 10.1016/j.jchf.2024.09.004 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.jchf.2024.09.004 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S2213177924006620 
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| Author Notes: | Mikhail N. Kosiborod, MD, Elke Platz, MD, MS, Sean Wharton, MD, Carel W. le Roux, MD, P HD, Martina Brueckmann, MD, Samina Ajaz Hussain, MD, MFPM, Anna Unseld, MS C, Elena Startseva, MD, MBA, Lee M. Kaplan, MD, PH D, the SYNCHRONIZE–CVOT Trial Committees and Investigators |
| Summary: | Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors may be more effective than GLP-1 receptor agonism alone in reducing body weight, but the cardiovascular (CV) effects are unknown. The authors describe the rationale and design of SYNCHRONIZE-CVOT, a phase 3, randomized, double-blind, parallel-group, event-driven, CV safety study of survodutide, a dual glucagon and GLP-1 receptor agonist, administered subcutaneously once weekly compared with placebo in adults with a body mass index ≥27 kg/m2 and established CV disease or chronic kidney disease, and/or at least 2 weight-related complications or risk factors for CV disease. The primary endpoint of SYNCHRONIZE-CVOT is time to first occurrence of the composite adjudicated endpoint of 5-point major adverse CV events. This global CV outcomes trial is currently enrolling, with a target recruitment of 4,935 participants. SYNCHRONIZE-CVOT is the first trial that will determine the CV safety and efficacy of survodutide in people with obesity and increased CV risk. (A Study to Test the Effect of Survodutide [BI 456906] on Cardiovascular Safety in People With Overweight or Obesity [SYNCHRONIZE-CVOT]; NCT06077864) |
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| Item Description: | Online verfügbar: 23. Oktober 2024, Artikelversion: 2. Dezember 2024 Gesehen am 10.04.2025 |
| Physical Description: | Online Resource |
| ISSN: | 2213-1787 |
| DOI: | 10.1016/j.jchf.2024.09.004 |