Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight o… (NCT07657676) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity
China116 participantsStarted 2026-05-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Signed informed consent
. Willing to comply with follow-up
Exclusion criteria
. History or evidence of the following :
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Mazdutide is being tested here to see if it can actually shrink the fatty, non-calcified plaque buildup in coronary arteries over 52 weeks — is that a meaningful goal for my specific situation, given where my plaque is and how advanced it is?
2This is a Phase 4 trial, which means the drug has already been approved for some use — can you explain what's already known about mazdutide's safety profile and whether any risks are particularly relevant for someone with my heart and weight history?
3The trial isn't recruiting yet, so if I were interested, how long might it realistically be before it opens, and in the meantime, is there a standard treatment plan I should already be starting for my coronary atherosclerosis?
4The study measures plaque changes using a CCTA scan — how many of those scans would I need over the 52 weeks, and given my condition, is repeated CT contrast imaging something I should be concerned about?
5Are there already approved medications or lifestyle interventions that target coronary plaque or weight in my situation, and how would participating in this trial compare to just pursuing those established options right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in total non-calcified plaque volume (NCPV) at 52 weeks measured by CCTA
Timeframe: 52 weeks
Trial details
NCT IDNCT07657676
SponsorChina National Center for Cardiovascular Diseases
. 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
. Presence of severe diseases such as malignant tumors, lymphoma, liver cirrhosis, HIV-positive status, etc., with an expected survival of less than 2 years
. Contraindications to GLP-1/GCG dual receptor agonists, such as hypersensitivity or severe intolerance
. A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2