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

StatusNot Yet Recruiting
PhasePhase 4
Started2026-09-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 31, 2027 → Dec 31, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from China National Center for Cardiovascular Diseases

Amendment history

2026-08-26
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v1
Primary endpoint(s) modified1 entry, revised
WasChange from baseline in total non-calcified plaque volume (NCPV) at 52 weeks measured by CCTA
NowChange in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks
Primary completion pushed: 2027-10-31 → 2027-12-31
Completion moved earlier: 2028-02-28 → 2027-12-31
Start date2026-05-25→2026-09-01
Eligibility criteria+37 characters
[...] creening). Coronary stenosis 30-70% confirmed by CAG or CCTA within 3 months prior to enrollment. Signed informed consent Willing to comply with follow-up Ex [...]
Secondary endpoints28 entries, revised
Change from baseline in RCA pericoronary fat attenuation index (RCA-FAI) atby CCTA from baseline to 52 weeks by CCTA Change from baseline in LAD pericoronary fat attenuation index (LAD-FAI) atby CCTA from baseline to 52 weeks by CCTA Change from baseline in LCX pericoronary fat attenuation index (LCX-FAI) atby CCTA from baseline to 52 weeks by CCTA Change from baseline in lesion pericoronary fat attenuation index (lesion-FAI) atby CCTA from baseline to 52 weeks by CCTA Change from baseline in total plaque volume (TPV) atby CCTA from baseline to 52 weeks by CCTA Change from baseline in percent [...] [...]
Study description-840 characters
ObesityCoronary prevalenceatherosclerosis hasis risenthe sharply,principal makingpathological elevatedsubstrate BMIunderlying most cardiovascular events and remains a leading cause of global mortalitymorbidity and disabilitymortality. Excess adiposity drives inflammationOverweight and coronaryobesity heartare disease,well-established highlighting an urgent need for effective pharmacological interventions to achieve sustained weight loss and reduce residual cardiovascularindependent risk. Non-calcified plaquesfactors representthat a key high-risk feature for cardiovascular events. Inflammation [...] [...]
Study sitescontacts updated at 1 of 1 site
2026-06-14
Original filing
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.
Trial Details
NCT Number NCT07657676
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Obesity & Overweight, Coronary Heart Disease
Enrollment 116 participants
Start Date 2026-09-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-28