Actively Recruiting
The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
Led by Tina Vilsbøll · Updated on 2025-05-22
124
Participants Needed
3
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed written consent
- Body Mass Index (BMI) of 27 kg/m2 or higher
- Age 18 years or older
- Referred for coronary angiogram due to stable angina
- Presence of coronary atheromatosis by angiography (obstructive or non-obstructive)
- Lipid Core Burden Index over 200 by NIRS in a vessel not treated with coronary intervention
You will not qualify if you...
- History of diabetes or HbA1c 48 mmol/mol (6.5%) or higher at baseline
- Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)
- History of coronary artery bypass surgery (CABG)
- Planned cardiovascular intervention at randomisation
- History of heart failure New York Heart Association class III or IV
- Left ventricular ejection fraction 35% or less
- Estimated glomerular filtration rate below 30 ml/min/1.53 m2
- History of pancreatitis or plasma amylase more than twice the upper normal limit
- Impaired liver function with ALT or AST more than three times the upper limit of normal
- Pregnancy, planned pregnancy, or breastfeeding
- Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- Hypersensitivity to tirzepatide or any excipients
- Left main stenosis 50% diameter or more or haemodynamically significant
- Chronic total occlusion of any major coronary vessel
- Multi-vessel disease or complex anatomy needing coronary bypass surgery
- Coronary anatomy or pathology preventing safe intravascular imaging in major arteries not treated with intervention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Rigshospitalet
Copenhagen, Denmark, 2100
Not Yet Recruiting
2
Gentofte Hospital
Gentofte Municipality, Denmark, 2900
Actively Recruiting
3
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
Actively Recruiting
Research Team
D
Daniel Raaschou-Oddershede, MD
CONTACT
C
Christine Rode Schwarz, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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