drugset / Trial / NCT07657676

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

NCT07657676

Phase 4 Not yet recruiting 116 enrolled China National Center for Cardiovascular Diseases
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-05-25
Primary completion
2027-10-31
Completion
2028-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Mazdutide Protein / enzyme biologic 6 mg Subcutaneous