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A Study of Semaglutide for Diabetic Patients with Heart Attack or Unstable Angina to Measure Changes in Coronary Artery Plaque Using Imaging

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study involves people who have diabetes mellitus and have experienced a specific type of heart problem called non-ST-elevation myocardial infarction, which is a type of heart attack, or unstable angina, which is chest pain that occurs when the heart does not get enough blood. These conditions happen when the arteries that supply blood to the heart become narrowed or blocked by fatty deposits called plaques. The study will use a medication called semaglutide, which is given as tablets taken by mouth. This medication is normally used to help control blood sugar levels in people with diabetes.

The purpose of this study is to see if semaglutide can reduce inflammation inside the plaques that build up in the heart arteries. Inflammation is a process where the body's immune system responds to damage or disease, and in this case, certain immune cells called macrophages collect in the plaques. The study will measure whether the medication can decrease the amount of these macrophages in the plaques. To do this, doctors will use a special imaging technique called optical coherence tomography, which is a way of taking detailed pictures of the inside of the arteries using light waves. This procedure allows doctors to see the structure and composition of the plaques.

During the study, participants will receive either semaglutide or a placebo for 24 weeks. At the beginning and end of this period, doctors will perform optical coherence tomography to examine the plaques in the arteries that are not the main blocked artery that caused the heart problem. The study will look at various features of these plaques, including their size, thickness of the covering layer, and the presence of different materials like fat and calcium. Doctors will also monitor blood sugar control, body weight, any heart-related events, and any side effects that may occur during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment procedure

    Upon joining the trial, you will undergo a procedure called percutaneous coronary intervention (a minimally invasive procedure to open blocked heart arteries using a catheter) to treat the identified culprit coronary lesion (the main blockage in your heart artery that caused your symptoms).

    During this procedure, imaging of your coronary arteries will be performed using optical coherence tomography, which is a technique that uses light waves to take detailed pictures of the inside of your arteries. This imaging will focus on a non-culprit stenosis (a narrowing in a different artery that is not the main cause of your current condition), specifically one with 30% to 69% narrowing that shows detectable macrophage presence (immune cells that indicate inflammation in the artery wall).

  2. Step 2

    Treatment assignment and medication start

    You will be randomly assigned to receive either semaglutide tablets or standard care without semaglutide.

    If assigned to the semaglutide group, you will begin taking Rybelsus 3 mg tablets by mouth. The specific dosage schedule, frequency of administration, and any dose adjustments during the treatment period will be determined according to the trial protocol.

  3. Step 3

    Treatment period

    You will continue your assigned treatment regimen for a period of 24 weeks (approximately 6 months).

    During this time, regular monitoring will occur to assess your HbA1c (a blood test that measures your average blood sugar levels over the past 2-3 months), body mass index (a measure of body fat based on height and weight), cardiovascular events (any heart-related complications), and any adverse effects (unwanted side effects from the treatment).

  4. Step 4

    Final assessment

    At the end of the 24-week treatment period, you will undergo a second optical coherence tomography imaging procedure of the same non-culprit coronary stenosis that was examined at the beginning of the trial.

    This imaging will measure changes in the macrophage arc (the amount of inflammatory cells present in the artery wall, measured in degrees), as well as other characteristics of the plaque including lumen area (the open space inside the artery), plaque volume (the amount of buildup in the artery wall), fibrous cap thickness (the thickness of the protective layer covering the plaque), and the presence of lipid and calcium (fat and mineral deposits in the plaque).

    The measurements from this final assessment will be compared to your baseline measurements to determine the effects of the treatment on coronary plaque composition and inflammation.

Who can join the trial?

8 criteria

  • You must have a diagnosis of Type 2 Diabetes Mellitus, which is a condition where your body does not use insulin properly, leading to high blood sugar levels.
  • You must have experienced Non-ST-segment elevation Acute Coronary Syndrome, which is a type of heart problem that occurs when blood flow to the heart muscle is suddenly reduced but not completely blocked.
  • You must have one identifiable main blocked area in your heart's blood vessels that has been treated with percutaneous coronary intervention, which is a procedure where doctors use a thin tube to open up blocked arteries in your heart.
  • You must have at least one other area in a different heart blood vessel that shows mild to moderate narrowing, between 30% to 69% blockage, that can be seen on imaging tests.
  • This additional narrowing must show signs of macrophage presence, which are special immune cells that can be detected using a special imaging technique called optical coherence tomography, a test that uses light waves to take detailed pictures inside your blood vessels.
  • This additional narrowing must be in a major heart blood vessel that is different from the one that was treated.
  • You must be 40 years of age or older.
  • You must have signed an informed consent form, which is a document showing you understand the study and agree to participate.

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the provided information.
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Investigated drugs

Semaglutide is a medication used to treat type 2 diabetes. It helps control blood sugar levels by working like a natural hormone in your body. In this trial, researchers want to see if this medication can also help reduce inflammation in the blood vessels of the heart in people who have diabetes and have had a heart attack or other serious heart problem.

What is already known about the treatment

Semaglutide – Semaglutide is a medication given as an oral tablet or injection under the skin that helps control blood sugar levels in people with type 2 diabetes and is also used for weight management. It works by mimicking a natural hormone in the body called GLP-1, which stimulates insulin release when blood sugar is high, slows down digestion, and reduces appetite. This medication belongs to a class of drugs called GLP-1 receptor agonists and is widely approved and used in clinical practice. In this clinical trial, researchers are studying whether semaglutide can reduce inflammation in the blood vessels of the heart, specifically by decreasing inflammatory cells called macrophages in coronary artery plaques of diabetic patients who have experienced acute coronary syndrome.

Investigated diseases

  • Non-ST-Elevation Myocardial Infarction

    This is a type of heart attack that occurs when blood flow to part of the heart muscle is severely reduced or blocked. Unlike other types of heart attacks, it does not show specific changes on an electrocardiogram test called ST-elevation. The condition happens when a blood clot partially blocks one of the coronary arteries that supply blood to the heart. This blockage prevents enough oxygen from reaching the heart muscle, causing damage to the heart tissue. The condition typically causes chest pain or discomfort that may spread to the arms, neck, or jaw. It requires immediate medical attention as the blocked artery needs to be reopened to restore blood flow to the heart.

  • Unstable Angina

    This is a condition where the heart muscle does not receive enough blood and oxygen, causing chest pain that occurs unpredictably, even at rest. It happens when fatty deposits called plaques build up in the coronary arteries and narrow them, reducing blood flow to the heart. Unlike stable angina, this type of chest pain is not relieved by rest or usual medications and may worsen over time. The pain can occur more frequently, last longer, and happen with less physical activity than before. This condition is considered a warning sign that a heart attack may occur soon. The chest discomfort may feel like pressure, squeezing, or heaviness in the chest area.

  • Diabetes Mellitus

    This is a chronic condition where the body cannot properly process blood sugar, also known as glucose. It occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that helps glucose enter the cells to be used for energy. When this process does not work correctly, glucose builds up in the bloodstream instead of being absorbed by cells. Over time, high blood sugar levels can damage various organs and systems throughout the body. Common symptoms include increased thirst, frequent urination, extreme hunger, unexplained weight loss, and fatigue.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523977-40-00Protocol codeARMYDA - 10Estimated enrolment90 patientsSponsorAzienda Ospedaliero-Universitaria Maggiore Della Carita

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