Trial · Interventional
RecruitingPhase 4Registry dataEffect 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
- Ph 4
Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity
NCT0765767614 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.
Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Secondary outcomes(20)
Change in RCA pericoronary fat attenuation index (RCA-FAI) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in LAD pericoronary fat attenuation index (LAD-FAI) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in LCX pericoronary fat attenuation index (LCX-FAI) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in lesion pericoronary fat attenuation index (lesion-FAI) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in total plaque volume (TPV) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in percent atheroma volume (PAV) by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in low-attenuation plaque volumes by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in fibrous plaque volumes by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in fibrofatty plaque volumes by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in calcified plaque volumes by CCTA from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in total cholesterol from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in triglycerides from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in LDL-C from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in non-HDL-C from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in ApoB from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in HbA1c from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Changein fasting glucose from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in uric acid from baseline to 52 weeks
Time frame · Baseline and 52 weeks
Change in Lp(a) from baseline to 52 weeks
Time frame · Baseline and 52 weeks
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
PepBank is a research reference. Talk to a doctor before you use any peptide.