Effects of Tirzepatide on Heart Health in Overweight Individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the long-term effects of tirzepatide, a medication for weight management, on coronary plaque composition and microvascular function in overweight and obese individuals with stable coronary artery disease. Participants will be randomly assigned to receive either tirzepatide or a placebo for 52 weeks. The study employs advanced imaging techniques, including NIRS and IVUS, to assess changes in coronary plaque and vascular health. Additionally, a sub-study will explore metabolic and cardiovascular predictors of plaque burden in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Gentofte Hospital
  Gentofte Municipality, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Not yet recruiting

Study contacts

• Principal investigator: Tina Vilsbøll, MD, DMSc — Steno Diabetes Center Copenhagen
• Study coordinator: Daniel Raaschou-Oddershede, MD
• Email: daniel.raaschou-oddershede@regionh.dk
• Phone: +4520157448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.