NCT06606821RecruitingPhase 4
The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
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
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 4 Sept 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 20 Mar 2027
- Lead sponsor
- Tina Vilsbøll
- Diseases
- Obesity, Coronary artery disease
- NCT number
- NCT06606821
- EU CT number
- 2023-505270-15-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 124
- From 1 Oct 2024 to the primary completion date, 20 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)
Other illness
- 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
- History of pancreatitis or plasma amylase \>2 times upper normal limit
- 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
- Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery
Lab values
- History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline
- Left ventricular ejection fraction (LVEF) ≤35%
- eGFR \<30 ml/min/1.53 m2
- Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal)
Other
- Pregnancy, planned pregnancy or breastfeeding
- Left main stenosis (≥50% diameter or haemodynamically significant)
- Chronic total occlusion of any major coronary vessel
- Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.