Status:
RECRUITING
The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
Lead Sponsor:
Tina Vilsbøll
Conditions:
Coronary Artery Disease
Coronary Microvascular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 (a...
Detailed Description
The anti-atherogenic effect of tirzepatide has been studied in preclinical studies and seems to involve mechanisms related to a reduction in vascular inflammation and lipid accumulation. Any direct an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06606821
Start Date
October 1 2024
End Date
August 1 2028
Last Update
May 22 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Gentofte Hospital
Gentofte Municipality, Denmark, 2900
3
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730