Mazdutide and coronary plaque in people with coronary artery disease and overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial will compare mazdutide to placebo over 52 weeks to see if it reduces non-calcified plaque volume in the coronary arteries, measured by CCTA. A substudy will use 18F-NaF PET/CT to assess plaque inflammation. Secondary outcomes include changes in fat inflammation around arteries, plaque composition, metabolic and inflammatory markers, and clinical outcomes. The trial targets adults with confirmed coronary stenosis and overweight or obesity, receiving standard care alongside the study drug or placebo. The global sponsor is the China National Center for Cardiovascular Diseases, with participating centers in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. 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).
3. Coronary stenosis 30-70% confirmed by CAG or CCTA within 3 months prior to enrollment.
4. Signed informed consent
5. Willing to comply with follow-up

Exclusion Criteria:

1. History or evidence of the following :

   1. A history of severe hypoglycemia, or recurrent symptomatic hypoglycemia (≥2 episodes) within the past six months
   2. 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%
   3. A hemorrhagic/ischemic stroke or transient ischemic attack within six months prior to screening
   4. A history of acute or chronic pancreatitis, gallbladder/bile duct disease, or pancreatic injury
   5. Presence of severe diseases such as malignant tumors, lymphoma, liver cirrhosis, HIV-positive status, etc., with an expected survival of less than 2 years
   6. Contraindications to GLP-1/GCG dual receptor agonists, such as hypersensitivity or severe intolerance
   7. A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
2. Use of the following medications or treatments prior to screening :

   1. Use of weight-affecting medications (e.g., systemic steroids, tricyclic antidepressants, psychiatric/sedative medications, etc.) within three months prior to screening
   2. Use of GLP-1 RA or GIP/GLP-1 RA (exposure to investigational drugs) within three months prior to screening
   3. Participation in other clinical trials (exposure to investigational drugs) within three months prior to screening
   4. Known clinically significant abnormal gastric emptying or current use of medications that directly affect gastrointestinal motility
3. Laboratory test results meeting any of the following criteria at screening (repeat testing within one week is permitted if there is a clear reason, and the reason for retesting must be documented by the investigator)

   1. Serum calcitonin ≥50 ng/L (pg/mL)
   2. ALT/AST \>3.0 × ULN
   3. eGFR \<30 mL/min/1.73m²
   4. Abnormal thyroid function (TSH \>6 mIU/L or \<0.4 mIU/L)
4. Pregnancy, planned pregnancy, or breastfeeding
5. Contraindications to CCTA, including severe allergy to iodine contrast agents, presence of cardiac implantable electronic devices or other metal implants that may affect image analysis
6. Inability to complete the study or comply with study requirements as determined by the investigator Exclusion criteria for the PET-CT substudy: All exclusion criteria of the main study, as well as contraindications to PET-CT examination

Where it's running

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Ke fei Dou — Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Xiao Wang
• Email: wangxiao@fuwai.com
• Phone: 86-10-88396953

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.