The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; no BMI minimum stated; conditions: Coronary Artery Disease; Coronary Microvascular Dysfunction; Overweight or Obesity; Stable Angina Pectoris
- Interventions
- Tirzepatide; Placebo
- Conditions
- Coronary Artery Disease; Coronary Microvascular Dysfunction; Overweight or Obesity; Stable Angina Pectoris; Chronic Coronary Artery Disease; Atherosclerosis Cardiovascular Disease
- Phase and size
- Phase 4 · 124 participants
- Dates
- Start 2024-10-01
Primary completion 2027-03-20 - Sponsor
- Tina Vilsbøll (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Lipid core burden indexBetween-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.