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

What Was Tested

This registered phase 4 trial tested Mazdutide.

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.

It had two arms (groups): Experimental: Mazdutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Overweight and obesity are well-established independent risk factors that drive the development and progression of coronary atherosclerotic plaque, and thus represent critical modifiable targets for therapeutic intervention.

Mazdutide, the first approved GLP-1/GCG dual receptor agonist, combines GLP-1-mediated insulin secretion and appetite suppression with GCG-driven energy expenditure.

Who Took Part

Enrollment: 116 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Signed informed consent. Willing to comply with follow-up.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: history or evidence of the following :; A history of severe hypoglycemia, or recurrent symptomatic hypoglycemia (≥2 episodes) within the past six months; A hemorrhagic/ischemic stroke or transient ischemic attack within six months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

The Mazdutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-09-14 with completion listed for 2027-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks (time frame: Baseline and 52 weeks).

It also tracked 28 secondary outcomes, for example Change in RCA pericoronary fat attenuation index (RCA-FAI) by CCTA from baseline to 52 weeks, Change in LAD pericoronary fat attenuation index (LAD-FAI) by CCTA from baseline to 52 weeks, Change in LCX pericoronary fat attenuation index (LCX-FAI) by CCTA from baseline to 52 weeks, Change in lesion pericoronary fat attenuation index (lesion-FAI) by CCTA from baseline to 52 weeks, Change in total plaque volume (TPV) by CCTA from baseline to 52 weeks and Change in percent atheroma volume (PAV) by CCTA from baseline to 52 weeks.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Mazdutide in 116 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.