The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Coronary Artery Disease, Coronary Microvascular Dysfunction, Overweight or Obesity, Stable Angina Pectoris, Chronic Coronary Artery Disease, Atherosclerosis Cardiovascular Disease
In brief
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.
Key facts
- Study ID
- NCT06606821
- Run by
- Tina Vilsbøll
- People needed
- 124
- Starts
- 2024-10-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Gentofte Hospital — Gentofte Municipality, Denmark (enrolling)
- Steno Diabetes Center Copenhagen — Herlev, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark
Full record on ClinicalTrials.gov
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