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Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity

2026年8月26日 更新者：Xiao Wang、China National Center for Cardiovascular Diseases

Effect of Mazdutide on Coronary Plaque Progression in Patients With Coronary Atherosclerosis and Overweight or Obesity: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the effect of mazdutide, a dual GLP-1/GCG receptor agonist, on coronary plaque progression assessed by coronary computed tomography angiography (CCTA) in patients with coronary atherosclerosis and overweight or obesity. The primary endpoint is the change in total non-calcified plaque volume (NCPV) from baseline to week 52. Secondary endpoints include changes in pericoronary adipose tissue inflammation (fat attenuation index, FAI), plaque composition, metabolic parameters, inflammatory biomarkers, and clinical outcomes. A substudy will include 18F-NaF PET/CT imaging.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Coronary atherosclerosis is the principal pathological substrate underlying most cardiovascular events and remains a leading cause of morbidity and mortality. Overweight and obesity are well-established independent risk factors that drive the development and progression of coronary atherosclerotic plaque, and thus represent critical modifiable targets for therapeutic intervention.

Prior studies have shown that GLP-1 receptor agonists (GLP-1RAs) provide hypoglycemic, weight-loss, and cardiovascular protective benefits. Mazdutide, the first approved GLP-1/GCG dual receptor agonist, combines GLP-1-mediated insulin secretion and appetite suppression with GCG-driven energy expenditure. Phase III trials have demonstrated robust glycemic and weight benefits, along with reductions in hs-CRP and liver fat. Given that dual-receptor activation yields more robust metabolic improvements than single-receptor agonism, mazdutide may possess greater potential than GLP-1 monotherapy in suppressing coronary plaque progression.

Therefore, we propose a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of 52 weeks of Mazdutide treatment on CCTA-assessed non-calcified plaque volume (NCPV) in patients with coronary atherosclerosis and overweight or obesity.

PET-CT substudy: A subset of eligible patients will be enrolled into a sub-study, we aim to evaluate the efficacy of Mazdutide on plaque inflammation assessed by 18F-NaF PET/CT.

研究类型

介入性

注册 (估计的)

116

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100037
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
        • 首席研究员：
          • Kefei Dou, MD
        • 接触：
        • 首席研究员：
          • Xiao Wang, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age ≥ 18 years
  2. BMI ≥ 28 kg/m2 or BMI≥ 24kg/m2 with at least one of the following conditions: dyslipidemia, metabolic associated fatty liver disease, hypertension, prediabetes, type 2 diabetes mellitus, or obesity-related obstructive sleep apnea syndrome (at screening or within 6 months prior to screening).
  3. Coronary stenosis 30-70% confirmed by CAG or CCTA within 3 months prior to enrollment.
  4. Signed informed consent
  5. Willing to comply with follow-up

Exclusion Criteria:

  1. History or evidence of the following :

    1. A history of severe hypoglycemia, or recurrent symptomatic hypoglycemia (≥2 episodes) within the past six months
    2. Severe heart disease as determined by the investigator, including coronary artery disease that has undergone or is planned for coronary artery bypass grafting or percutaneous coronary intervention, valvular heart disease requiring valve repair or replacement, heart transplantation, severe heart failure (NYHA III-IV) or cardiogenic shock, or a known history of left ventricular ejection fraction ≤30%
    3. A hemorrhagic/ischemic stroke or transient ischemic attack within six months prior to screening
    4. A history of acute or chronic pancreatitis, gallbladder/bile duct disease, or pancreatic injury
    5. Presence of severe diseases such as malignant tumors, lymphoma, liver cirrhosis, HIV-positive status, etc., with an expected survival of less than 2 years
    6. Contraindications to GLP-1/GCG dual receptor agonists, such as hypersensitivity or severe intolerance
    7. A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

  2. Use of the following medications or treatments prior to screening :

    1. Use of weight-affecting medications (e.g., systemic steroids, tricyclic antidepressants, psychiatric/sedative medications, etc.) within three months prior to screening
    2. Use of GLP-1 RA or GIP/GLP-1 RA (exposure to investigational drugs) within three months prior to screening
    3. Participation in other clinical trials (exposure to investigational drugs) within three months prior to screening
    4. Known clinically significant abnormal gastric emptying or current use of medications that directly affect gastrointestinal motility

  3. Laboratory test results meeting any of the following criteria at screening (repeat testing within one week is permitted if there is a clear reason, and the reason for retesting must be documented by the investigator)

    1. Serum calcitonin ≥50 ng/L (pg/mL)
    2. ALT/AST >3.0 × ULN
    3. eGFR <30 mL/min/1.73m²
    4. Abnormal thyroid function (TSH >6 mIU/L or <0.4 mIU/L)
  4. Pregnancy, planned pregnancy, or breastfeeding
  5. Contraindications to CCTA, including severe allergy to iodine contrast agents, presence of cardiac implantable electronic devices or other metal implants that may affect image analysis
  6. Inability to complete the study or comply with study requirements as determined by the investigator Exclusion criteria for the PET-CT substudy: All exclusion criteria of the main study, as well as contraindications to PET-CT examination

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：Placebo
Placebo administered subcutaneously once weekly, starting at 2 mg for 4 weeks, then escalated to 4 mg for 4 weeks, and then to 6 mg thereafter until week 52.
实验性的：Experimental: Mazdutide
药品：Mazdutide
Mazdutide administered subcutaneously once weekly, starting at 2 mg for 4 weeks, then escalated to 4 mg for 4 weeks, and then to 6 mg thereafter until week 52.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks

次要结果测量

结果测量
大体时间
Change in RCA pericoronary fat attenuation index (RCA-FAI) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in LAD pericoronary fat attenuation index (LAD-FAI) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in LCX pericoronary fat attenuation index (LCX-FAI) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in lesion pericoronary fat attenuation index (lesion-FAI) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in total plaque volume (TPV) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in percent atheroma volume (PAV) by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in low-attenuation plaque volumes by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in fibrous plaque volumes by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in fibrofatty plaque volumes by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in calcified plaque volumes by CCTA from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in total cholesterol from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in triglycerides from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in LDL-C from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in non-HDL-C from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in ApoB from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in HbA1c from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Changein fasting glucose from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in uric acid from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in Lp(a) from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in hs-CRP from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in IL-6 from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in TNF-α from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in body weight from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in waist circumference from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in waist-to-hip ratio from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in SBP from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in DBP from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Incidence of major adverse cardiovascular events (MACE) at 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks

其他结果措施

结果测量
大体时间
Change in liver stiffness measurement by vibration-controlled transient elastography from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks
Change in controlled attenuation parameter by vibration-controlled transient elastography from baseline to 52 weeks
大体时间：Baseline and 52 weeks
Baseline and 52 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China National Center for Cardiovascular Diseases

调查人员

  • 首席研究员：Xiao Wang、Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
  • 首席研究员：Ke fei Dou、Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年6月14日

首先提交符合 QC 标准的

2026年6月14日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-3068

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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