Skip to content

Trial · Interventional

RecruitingPhase 4Registry data

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

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
116 participants (estimated)
Sponsor
China National Center for Cardiovascular Diseases · Other gov
Design
Randomized · Triple masking
Countries
1 country

China

Start
14 Sept 2026
Primary completion
31 Dec 2027 (estimated)
Completion
31 Dec 2027 (estimated)
First posted
18 Jun 2026
Last update posted
13 Oct 2026
Conditions
Obesity & Overweight · Coronary Heart Disease

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 4

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

    NCT07657676

    14 Sept 2026 to est. 31 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MazdutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Experimental: Mazdutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

Secondary outcomes(20)
  1. Change in RCA pericoronary fat attenuation index (RCA-FAI) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  2. Change in LAD pericoronary fat attenuation index (LAD-FAI) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  3. Change in LCX pericoronary fat attenuation index (LCX-FAI) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  4. Change in lesion pericoronary fat attenuation index (lesion-FAI) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  5. Change in total plaque volume (TPV) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  6. Change in percent atheroma volume (PAV) by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  7. Change in low-attenuation plaque volumes by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  8. Change in fibrous plaque volumes by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  9. Change in fibrofatty plaque volumes by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  10. Change in calcified plaque volumes by CCTA from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  11. Change in total cholesterol from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  12. Change in triglycerides from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  13. Change in LDL-C from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  14. Change in non-HDL-C from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  15. Change in ApoB from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  16. Change in HbA1c from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  17. Changein fasting glucose from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  18. Change in uric acid from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  19. Change in Lp(a) from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

  20. Change in hs-CRP from baseline to 52 weeks

    Time frame · Baseline and 52 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.