← Trials/Trial dossier/NCT07657676

Not yet recruitingPhase 4

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

Effect of Mazdutide on Coronary Plaque Progression in Patients With Coronary Atherosclerosis and Overweight or Obesity: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

116

estimated

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoint

Total non-calcified plaque volume (NCPV)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07657676
Org study ID2026-3068

Timeline

Milestones

Study start2026-05-25estimated
Study first posted2026-06-18actual
Last update posted2026-06-18actual
Primary completion2027-10-31estimated
Study completion2028-02-28estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

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

Endpoints (29)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
16
Cardiometabolic biomarkers
7
Weight & body composition
3
Glycemic / diabetes
2
Cardiovascular outcomes
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

Incidence of major adverse cardiovascular events (MACE) at 52 weeks

Time frame:52 weeks

event count, event

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change from baseline in body weight at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist-to-hip ratio at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from baseline in HbA1c at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting glucose at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Change from baseline in total cholesterol at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in triglycerides at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in LDL-C at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in non-HDL-C at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in ApoB at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in uric acid at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in hs-CRP at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Other (unclassified)

16 endpoints
Primary/protocol endpoint/low confidence

Change from baseline in total non-calcified plaque volume (NCPV) at 52 weeks measured by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in RCA pericoronary fat attenuation index (RCA-FAI) at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in total plaque volume (TPV) at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in percent atheroma volume (PAV) at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in low-attenuation plaque volumes at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in fibrous plaque volumes at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in fibrofatty plaque volumes at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in calcified plaque volumes at 52 weeks by CCTA

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in Lp(a) at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in IL-6 at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in TNF-α at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in SBP at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in DBP at 52 weeks

Time frame:52 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.