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)

中文翻译：

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Survodutide 治疗肥胖症：SYNCHRONIZE 心血管结局试验的基本原理和设计


胰高血糖素和胰高血糖素样肽-1 （GLP-1） 受体的双重激动作用可能比单独的 GLP-1 受体激动作用在减轻体重方面更有效，但心血管 （CV） 效应尚不清楚。作者描述了 SYNCHRONIZE-CVOT 的基本原理和设计，这是一项 3 期、随机、双盲、平行组、事件驱动的 CV 安全性研究，研究 survodutide（一种胰高血糖素和 GLP-1 受体激动剂），与安慰剂相比，每周皮下给药一次体重指数为 ≥27 kg/m2 并确诊为 CV 疾病或慢性肾病，和/或至少 2 种与体重相关的并发症或 CV 疾病的危险因素。SYNCHRONIZE-CVOT 的主要终点是 5 分主要不良 CV 事件的复合判定终点首次出现的时间。这项全球 CV 结果试验目前正在招募中，目标招募 4,935 名参与者。SYNCHRONIZE-CVOT 是第一个确定 survodutide 在肥胖和 CV 风险增加人群中的 CV 安全性和有效性的试验。（一项测试 survodutide [BI 456906] 对超重或肥胖患者心血管安全影响的研究 [SYNCHRONIZE–CVOT];NCT06077864）