NCT06606821 The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
| NCT ID | NCT06606821 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tina Vilsbøll |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 124 participants in total. It began in 2024-10-01 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
Eligibility Criteria
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
Contact & Investigator
Tina Vilsbøll, MD, DMSc
PRINCIPAL INVESTIGATOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT06606821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06606821 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06606821 currently recruiting?
Yes, NCT06606821 is actively recruiting participants. Contact the research team at daniel.raaschou-oddershede@regionh.dk for enrollment information.
Where is the NCT06606821 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Gentofte Municipality, Denmark, Herlev, Denmark.
Who is sponsoring the NCT06606821 clinical trial?
NCT06606821 is sponsored by Tina Vilsbøll. The principal investigator is Tina Vilsbøll, MD, DMSc at Steno Diabetes Center Copenhagen. The trial plans to enroll 124 participants.