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

Sponsor
China National Center for Cardiovascular Diseases
Study ID
NCT07657676
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Coronary Heart Disease
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    Mazdutide administered subcutaneously once weekly, starting at 2 mg for 4 weeks, then escalated to 4 mg for 4 weeks, and then to 6 mg thereafter until week 52.
  • Placebo — DRUG
    Placebo administered subcutaneously once weekly, starting at 2 mg for 4 weeks, then escalated to 4 mg for 4 weeks, and then to 6 mg thereafter until week 52.

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
May 25, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Mazdutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in total non-calcified plaque volume (NCPV) at 52 weeks measured by CCTA [ Time Frame: 52 weeks ]

Central Contacts

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