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Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity
Sponsor: China National Center for Cardiovascular Diseases
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2026-09-14
Completion Date
2027-12-31
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China