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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 13, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07657676). This is a study registration, not published results. Lead sponsor: China National Center for Cardiovascular Diseases. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 116 participants (ESTIMATED). Conditions: Obesity & Overweight, Coronary Heart Disease. Interventions: DRUG: Mazdutide; DRUG: Placebo. Primary outcome measures: Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks , Baseline and 52 weeks. Brief 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.