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New treatment option for Coronary Artery Disease
Official title The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease
ClinicalTrials.gov ID: NCT06606821
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for coronary artery disease.
Also referred to as LY3298176.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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%
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Gentofte Municipality, Denmark
- Herlev, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Gentofte Municipality, Denmark; Herlev, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.