Effects of Tirzepatide on Heart Health in Overweight Individuals
The Effects of Tirzepatide on Coronary Plaque Lipid Content and Myocardial Microvascular Function in Overweight and Obese People With Coronary Disease - The IDEAL-COR Study
This study tests if tirzepatide can improve heart health and reduce plaque in the arteries of overweight people with stable coronary artery disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT06606821 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effects of tirzepatide, a medication for weight management, on coronary plaque composition and microvascular function in overweight and obese individuals with stable coronary artery disease. Participants will be randomly assigned to receive either tirzepatide or a placebo for 52 weeks. The study employs advanced imaging techniques, including NIRS and IVUS, to assess changes in coronary plaque and vascular health. Additionally, a sub-study will explore metabolic and cardiovascular predictors of plaque burden in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI of 27 kg/m2 or higher and stable angina due to coronary atheromatosis.
Not a fit: Patients with a history of diabetes, severe heart failure, or those undergoing planned cardiovascular interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and reduced risk of heart disease in overweight individuals.
How similar studies have performed: Previous studies have shown promising results with tirzepatide in reducing cardiovascular risk factors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed written consent * BMI equal to or above 27 kg/m2 * Age 18 years or older * Referred to coronary angiogram (CAG) due to stable angina * Coronary atheromatosis by angiography (obstructive or non-obstructive) * LCBI4mm \>200 by NIRS in a vessel not subjected to coronary intervention Exclusion Criteria: * History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline * Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA) * History of coronary artery bypass surgery (CABG) * Planned CV intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation * History of heart failure New York Heart Association (NYHA) class III or IV * Left ventricular ejection fraction (LVEF) ≤35% * eGFR \<30 ml/min/1.53 m2 * History of pancreatitis or plasma amylase \>2 times upper normal limit * Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal) * Pregnancy, planned pregnancy or breastfeeding * Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC) * Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients * Left main stenosis (≥50% diameter or haemodynamically significant) * Chronic total occlusion of any major coronary vessel * Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery * Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention
Where this trial is running
Copenhagen and 2 other locations
- Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Gentofte Hospital — Gentofte Municipality, Denmark (Recruiting)
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Tina Vilsbøll, MD, DMSc — Steno Diabetes Center Copenhagen
- Study coordinator: Daniel Raaschou-Oddershede, MD
- Email: daniel.raaschou-oddershede@regionh.dk
- Phone: +4520157448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.