Key result
Phase 3 trial SYNCHRONIZE-CVOT evaluates survodutide for MACE reduction in obesity with cardiovascular risk.
Why the study?
Does survodutide reduce the risk of 5-point major adverse cardiovascular events in adults with a body mass index ≥27 kg/m2 and increased cardiovascular risk?
RCT (n=4,935)
Double-blind
parallel-group
Yes
Does survodutide reduce the risk of 5-point major adverse cardiovascular events in adults with a body mass index ≥27 kg/m2 and increased cardiovascular risk?
Answers are grounded in this paper and cite their sources.
SYNCHRONIZE-CVOT is an ongoing phase 3 trial designed to determine the cardiovascular safety and efficacy of the dual glucagon/GLP-1 receptor agonist survodutide in patients with overweight or obesity and increased cardiovascular risk.
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]
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Kosiborod et al. (2024) conducted an RCT in Obesity and increased cardiovascular risk (n=4,935). Survodutide vs. Placebo was evaluated on Time to first occurrence of the composite adjudicated endpoint of 5-point major adverse cardiovascular events. SYNCHRONIZE-CVOT is an ongoing phase 3 trial designed to evaluate the cardiovascular safety and efficacy of survodutide compared with placebo in adults with obesity and increased cardiovascular risk.
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