RecruitingPhase 4NCT05708859

Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT


Sponsor

Matthew J. Budoff

Enrollment

120 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether tirzepatide — a medication used for type 2 diabetes and weight loss — can slow or reduce the buildup of fatty plaques in the heart's arteries, as measured by a specialized CT scan. **You may be eligible if...** - You are between 40 and 80 years old - You have had type 2 diabetes for at least 5 years with HbA1c (blood sugar control measure) between 7.0% and 10.5% - Your BMI is 25 or higher - You have at least two identifiable plaques in your coronary arteries on a CT scan - Your current diabetes medications have been stable for more than 4 weeks **You may NOT be eligible if...** - You recently had a heart attack, stroke, or major heart event (within the last 60 days) - You have type 1 diabetes - You are already using a GLP-1 receptor agonist (e.g., semaglutide, liraglutide) - You have a history of pancreatitis, thyroid cancer, or medullary thyroid cancer in your family - You have had or are planning heart bypass or stent procedures - You have had severe low blood sugar episodes recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Tirzepatide 15mg Subcutaneous Solution

DRUGPlacebo

Volume matched Subcutaneous Solution


Locations(1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)

Torrance, California, United States

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NCT05708859


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