Eli Lilly and Company (NYSE: LLY) today announced topline results from SURPASS-CVOT, a first-of-its-kind head-to-head Phase 3 cardiovascular outcomes trial comparing two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, was compared to Trulicity (dulaglutide), a GLP-1 receptor agonist that showed a definitive cardiovascular benefit in the REWIND study. In SURPASS-CVOT, Mounjaro achieved the primary objective by demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack or stroke vs. Trulicity. In addition, while not controlled for multiplicity-adjusted type-1 error, Mounjaro showed improvements on key measures of A1C, weight, renal function and all-cause mortality. The trial, which enrolled more than 13,000 participants across 30 countries and lasted more than four and a half years, is the largest and longest study of tirzepatide to date.

礼来公司（纽约证券交易所代码：LLY）今天宣布了 SURPASS-CVOT 的主要结果，这是一项史无前例的头对头 3 期心血管结局试验，比较了两种肠促胰岛素疗法在患有 2 型糖尿病和已确诊的动脉粥样硬化性心血管疾病成人中的治疗。将 GIP/GLP-1 双受体激动剂 Mounjaro（替泽帕肽）与 GLP-1 受体激动剂 Trulicity（度拉鲁肽）进行了比较，后者在 REWIND 研究中显示出明确的心血管益处。在 SURPASS-CVOT 中，Mounjaro 通过证明主要不良心血管事件 （MACE-3） 的发生率不劣，实现了主要目标，包括心血管死亡、心脏病发作或中风与 Trulicity 相比。此外，虽然没有控制多重性调整的 1 类错误，但 Mounjaro 在 A1C、体重、肾功能和全因死亡率的关键指标上显示出改善。该试验招募了来自 30 个国家的 13,000 多名参与者，持续了四年半多，是迄今为止规模最大、时间最长的替西帕肽研究。

"Cardiovascular disease remains the leading cause of death among people living with type 2 diabetes," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "The SURPASS-CVOT results show that Mounjaro preserved the cardioprotective benefit of Trulicity, a GLP-1 receptor agonist, while providing additional benefits, including greater kidney protection and a reduced overall risk of death. These findings strengthen the case for Mounjaro as a potential front-line treatment for people with type 2 diabetes and cardiovascular disease."

“心血管疾病仍然是 2 型糖尿病患者死亡的主要原因，”礼来公司执行副总裁兼总裁肯尼思·卡斯特博士说。“SURPASS-CVOT 结果表明，Mounjaro 保留了 GLP-1 受体激动剂 Trulicity 的心脏保护益处，同时提供了额外的益处，包括更好的肾脏保护和降低总体死亡风险。这些发现加强了 Mounjaro 作为 2 型糖尿病和心血管疾病患者的潜在一线治疗方法的理由。

In the trial, the risk of cardiovascular death, heart attack, or stroke was 8% lower for Mounjaro vs. Trulicity (hazard ratio: 0.92; 95.3% CI: 0.83 to 1.01), meeting the prespecified criteria for non-inferiority (upper limit of 95.3% CI of the hazard ratio < 1.05).1,2 Mounjaro showed consistent results across all three components of the MACE-3 composite endpoint. The rate of all-cause mortality was 16% lower for Mounjaro vs. Trulicity (hazard ratio: 0.84; 95.0% CI: 0.75 to 0.94).

在试验中，Mounjaro组与Trulicity组相比，心血管死亡、心脏病发作或中风的风险降低8%（风险比：0.92;95.3%CI：0.83-1.01），符合预先规定的非劣效性标准（风险比的上限为95.3%CI <1.05）。1,2Mounjaro 在 MACE-3 复合终点的所有三个组成部分中都显示出一致的结果。Mounjaro 与 Trulicity 相比，全因死亡率降低了 16%（风险比：0.84;95.0% CI：0.75 至 0.94）。

A pre-specified indirect comparison analysis of matched patient-level data from the REWIND and SURPASS-CVOT studies found that Mounjaro reduced the risk of MACE-3 by 28% (hazard ratio: 0.72; 95.0% CI: 0.55 to 0.94) and all-cause mortality by 39% (hazard ratio: 0.61; 95.0% CI: 0.45 to 0.82) compared to a putative placebo.3,4 In another key pre-specified analysis of participants with high or very-high risk of chronic kidney disease, Mounjaro slowed eGFR decline by 3.54 mL/min/1.73 m2 at 36 months vs. Trulicity (95.0% CI: 2.57 to 4.50).

对REWIND和SURPASS-CVOT研究的匹配患者水平数据进行预先指定的间接比较分析发现，与假定的安慰剂相比，Mounjaro将MACE-3的风险降低了28%（风险比：0.72;95.0%CI：0.55至0.94），全因死亡率降低了39%（风险比：0.61;95.0%CI：0.45至0.82）。3,4在另一项针对慢性肾病高风险或极高风险参与者的关键预先指定分析中，Mounjaro 将 eGFR 下降速度减缓了 3.54 mL/min/1.73 m236 个月时与 Trulicity（95.0% CI：2.57 至 4.50）。

In the trial, Mounjaro also led to greater improvements in A1C, weight and cardiovascular biomarkers, including lipids and systolic blood pressure, compared to Trulicity.3 The safety and tolerability of Mounjaro and Trulicity were generally consistent with their established profiles. The most commonly reported adverse events in SURPASS-CVOT for both Mounjaro and Trulicity were gastrointestinal-related, generally mild-to-moderate in severity, and mostly resolved after dose escalation was complete. During the trial, 13.3% of participants taking Mounjaro discontinued treatment due to adverse events, compared to 10.2% of participants taking Trulicity.

在试验中，与 Trulicity 相比，Mounjaro 还导致 A1C、体重和心血管生物标志物（包括血脂和收缩压）的更大改善。3Mounjaro 和 Trulicity 的安全性和耐受性与其既定概况基本一致。Mounjaro 和 Trulicity 的 SURPASS-CVOT 中最常报告的不良事件与胃肠道相关，严重程度通常为轻度至中度，并且大部分在剂量递增完成后得到解决。在试验期间，服用 Mounjaro 的参与者中有 13.3% 因不良事件而停止治疗，而服用 Trulicity 的参与者中这一比例为 10.2%。

Detailed results for SURPASS-CVOT will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 in September and published in a peer-reviewed journal. Lilly plans to submit these data to global regulatory authorities by the end of this year.

SURPASS-CVOT 的详细结果将于 9 月在 2025 年欧洲糖尿病研究协会 （EASD） 年会上公布，并发表在同行评审期刊上。礼来公司计划在今年年底前向全球监管机构提交这些数据。