The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
RecruitingPhase 4NCT06606821
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Coronary Artery Disease
- Coronary Microvascular Dysfunction
- Overweight or Obesity
- Stable Angina Pectoris
- Chronic Coronary Artery Disease
- Atherosclerosis Cardiovascular Disease
- Interventions
- Drug: Tirzepatide
- Drug: Placebo
- Sponsor
- Tina Vilsbøll
- Organization
- Steno Diabetes Center Copenhagen
- Start date
- 2024-10-01
- Primary completion
- 2027-03-20
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06606821