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Study on the Effects of Tirzepatide on Heart Health in Overweight and Obese Patients with Coronary Artery Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called tirzepatide on individuals who are overweight or obese and have a condition known as coronary artery disease. Coronary artery disease is a heart condition where the blood vessels that supply the heart with blood become narrowed or blocked. The study will compare the effects of tirzepatide, which is given as a solution for injection, with a placebo, which is a substance with no active medication.

The purpose of the study is to investigate how tirzepatide affects the composition and progression of coronary plaque, which is a buildup of substances in the arteries, and the function of small blood vessels in the heart. Participants in the study will receive either tirzepatide or a placebo once a week. The study will last for about 52 weeks, during which time the changes in the coronary plaque and the function of the heart's small blood vessels will be monitored.

Throughout the study, participants will undergo various assessments to measure the effects of the treatment. These assessments will include imaging techniques to evaluate the coronary plaque and tests to assess the function of the heart's small blood vessels. The goal is to understand whether tirzepatide can help improve heart health in people with coronary artery disease who are also dealing with issues related to being overweight or obese.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as a body mass index (BMI) of 27 kg/m² or higher, age of 18 years or older, and specific coronary conditions.
Participants must have been referred for coronary angiography due to stable angina and have certain coronary characteristics identified through imaging techniques.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes imaging of the coronary vessels to determine the lipid core burden index (LCBI) and other relevant parameters.
Step 3
Medication administration
Participants receive a once-weekly subcutaneous injection. The medication used is either tirzepatide or a placebo (saline solution).
The dosage for tirzepatide is 15 mg, administered using a pre-filled pen.
Step 4
Ongoing monitoring
Throughout the study, participants undergo regular monitoring to assess changes in coronary plaque composition and microvascular function.
This includes imaging techniques such as near-infrared spectroscopy (NIRS) and coronary intravascular ultrasound (IVUS) to evaluate plaque burden and other factors.
Step 5
Final assessment
At the end of the 52-week period, a final assessment is conducted to compare changes from the baseline measurements.
The primary focus is on the difference in the lipid core burden index between the group receiving tirzepatide and the placebo group.

Who can join the trial?

5 criteria

The patient must have a BMI (Body Mass Index) of 27 or higher. This is a measure of body fat based on height and weight.
The patient must be 18 years old or older.
The patient must have been referred for a procedure called coronary angiography (CAG) because of stable angina, which is a type of chest pain.
The patient must have coronary atheromatosis, which means there is a buildup of fatty deposits in the heart's blood vessels, as seen in the angiography. This can be either obstructive (blocking blood flow) or non-obstructive (not blocking blood flow).
The patient must have a lipid core burden index (LCBI) greater than 200 in a specific measurement by a technique called near-infrared spectroscopy (NIRS) in a blood vessel that has not had any coronary intervention. This index measures the amount of fatty material in the blood vessel.

Who cannot join the trial?

5 criteria

Individuals who do not have **overweight** or **obesity** cannot participate. **Overweight** means having more body weight than is considered healthy, and **obesity** means having a lot of extra body fat.
People who do not have **stable coronary artery disease** are excluded. This condition involves the heart's blood vessels being narrowed or blocked, but it is not currently causing severe symptoms.
Participants must be within certain age ranges, typically adults, but specific age limits are not provided here.
Both **male** and **female** participants are allowed, so gender is not a reason for exclusion.
Individuals considered part of a **vulnerable population** are not excluded, meaning the study does not specifically prevent participation based on vulnerability.

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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Tirzepatide is a medication being studied for its effects on coronary plaque composition and microvascular function in people who are overweight or obese and have stable coronary artery disease. It is administered once a week and aims to help reduce the lipid content in coronary plaques and improve heart health by enhancing the function of small blood vessels in the heart.

What is already known about the treatment

Tirzepatide – Tirzepatide is administered as a once-weekly injection under the skin. It is currently being studied in clinical trials for its effects on coronary plaque and heart function in people who are overweight or obese with coronary artery disease. The main therapeutic indication for tirzepatide is to manage weight and improve heart health in these individuals. At the molecular level, tirzepatide works by mimicking hormones that regulate blood sugar and appetite, helping to reduce food intake and improve insulin sensitivity. It is classified as a dual agonist of the GLP-1 and GIP receptors, which are involved in metabolic processes.

Investigated diseases

Overweight and Obesity
Overweight and obesity are conditions characterized by excessive body fat accumulation that may impair health. They develop when calorie intake exceeds calorie expenditure, leading to an energy imbalance. Over time, this can result in increased body weight and fat storage. These conditions are often associated with a sedentary lifestyle and poor dietary habits. They can lead to various health issues, including increased risk of heart disease, diabetes, and joint problems. Managing weight through lifestyle changes is crucial to prevent further health complications.
Coronary Artery Disease
Coronary artery disease is a condition where the coronary arteries, which supply blood to the heart muscle, become narrowed or blocked. This is usually due to the buildup of cholesterol and other substances, forming plaques on the artery walls. As the disease progresses, it can reduce blood flow to the heart, leading to chest pain or discomfort known as angina. Over time, it can weaken the heart muscle and contribute to heart failure. The disease often develops slowly and can be influenced by factors such as high blood pressure, smoking, and high cholesterol levels.