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.
Age ≥ 18 years
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).
Coronary stenosis 30-70% confirmed by CAG or CCTA within 3 months prior to enrollment.
Signed informed consent
A history of severe hypoglycemia, or recurrent symptomatic hypoglycemia (≥2 episodes) within the past six months
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%
A hemorrhagic/ischemic stroke or transient ischemic attack within six months prior to screening
A history of acute or chronic pancreatitis, gallbladder/bile duct disease, or pancreatic injury
Parallel
Mazdutide
DrugMazdutide 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.
Placebo
DrugPlacebo 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.
Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks
Change in RCA pericoronary fat attenuation index (RCA-FAI) by CCTA from baseline to 52 weeks
Change in LAD pericoronary fat attenuation index (LAD-FAI) by CCTA from baseline to 52 weeks
Change in LCX pericoronary fat attenuation index (LCX-FAI) by CCTA from baseline to 52 weeks
Change in lesion pericoronary fat attenuation index (lesion-FAI) by CCTA from baseline to 52 weeks
Change in liver stiffness measurement by vibration-controlled transient elastography from baseline to 52 weeks
Change in controlled attenuation parameter by vibration-controlled transient elastography from baseline to 52 weeks
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