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T-PLAQUE

RecruitingPhase 4

Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

Lead sponsor

Matthew J. Budoff

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Cardiovascular disease, Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥25HbA1c 7-10.5%

Primary endpoint

Total non-calcified coronary plaque volume

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 IDNCT05708859
Org study ID22915-01

Timeline

Milestones

Study first posted2023-02-01actual
Study start2024-01-02actual
Last update posted2024-10-15actual
Primary completion2025-12estimated (month precision)
Study completion2026-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female 40 years to 80 years of age at signing of informed consent

2. Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%

3. Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

4. Presence of two discrete coronary artery plaques with visual diameter stenosis >20% on CCTA

5. At the baseline visit, participants must be on a stable (>4 weeks) regiment of diabetes medications.

6. Patients using oral hormonal contraceptives must switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation

Exclusion criteria

1. Have had a major cardiovascular event within the last 60 days

2. Have type 1 diabetes mellitus

3. Current use of GLP1-RA

4. Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months

5. Are currently planning treatment for diabetic retinopathy and/or macular edema

6. Have history of, or currently planning a coronary, carotid, or peripheral artery revascularization (ie - stent, bypass)

7. Have a history of pancreatitis

8. Have a history of ketoacidosis or hyperosmolar state/coma

9. Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery

10. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years

11. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

12. Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement

13. Planned or Prior Bypass surgery

14. Contradiction for CCTA (e.g. serious allergic reaction to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA visit as assessed by the imaging core lab.

15. Uncontrolled severe hypertension: systolic blood pressure > 180 mmHg or diastolic BP > 100 mm Hg prior to randomization (assessed at the screening visit) despite antihypertensive therapy

16. Heart Failure NYHA Class III or IV at the screening visit

17. Renal insufficiency (eGFR <40 ml/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit.

18. Hospitalization for major cardiovascular event including heart failure in the past 2 months

Endpoints (4)

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

Cardiometabolic biomarkers
2
Cardiovascular outcomes
1
Glycemic / diabetes
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Reduction of total non-calcified coronary plaque volume

Time frame:12 months

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in HgA1c lab values in the blood.

Time frame:12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint/low confidence

Reduction of low attenuation plaque volume

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Reduction of total plaque volume, fibrous, lipid-rich and calcified plaque volumes using CCTA

Time frame:12 months

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.