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Effect of semaglutide, acetylsalicylic acid, and clopidogrel on blood clotting in patients with diabetes or overweight with cardiovascular disease

Registered 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 investigates the effects of semaglutide on platelet reactivity, which refers to how easily blood cells called platelets clump together to form clots. The research focuses on individuals living with Diabetes Mellitus, Obesity, or being Overweight, especially those who also have Cardiovascular Disease. Participants may be using aspirin or clopidogrel, which are medications used to prevent blood clots.

The purpose of the study is to evaluate how different forms and doses of semaglutide affect the way blood clots in these specific groups. One group of participants will use Rybelsus, which is an oral tablet, while another group may use Wegovy, which is a subcutaneous injection, meaning it is administered through a needle just under the skin. Some participants will receive a placebo or compare these treatments against existing medications like acetylsalicylic acid.

During the study, participants will follow a specific treatment plan involving either tablets or injections over a set period. Researchers will monitor various biological markers, including indicators of inflammation and how well the blood vessels are functioning, to observe changes in the body's response to the medications.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation and treatment
The participation in the study begins with the administration of either oral semaglutide or a comparator medication to observe the effects on platelet reactivity, which refers to how blood cells called platelets work together to form clots.
If assigned to the oral semaglutide group, rybelsus tablets will be taken. the dose may be 3 mg, 7 mg, or 14 mg taken by mouth.
If assigned to the subcutaneous semaglutide group, wegovy will be administered via injection under the skin. the dosage levels may include 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg.
If assigned to the comparator group, clopidogrel medreg 75 mg tablets or acetylsalicylic acid krka 100 mg tablets will be taken by mouth.
Step 2
Monitoring and measurements
During the trial, assessments are conducted at specific time points labeled t1, t2, and t3.
At time point t3, platelet reactivity is measured using a method called light transmission aggregometry, which tests how platelets respond to specific triggers like adp and collagen.
Various markers in the blood are also monitored at t1, t2, and t3, including indicators of thrombus formation (blood clot formation), inflammatory markers (signs of swelling or irritation in the body), oxidative stress markers, endothelial function (the health of the lining of the blood vessels), and autophagy markers (the process by which cells clean out damaged components).

Who can join the trial?

10 criteria

You have Type 2 Diabetes, which is a condition where your body does not use insulin properly, making your blood sugar levels too high.
You are suggested to receive GLP-1 RA treatment, which is a specific type of medication used to manage blood sugar or weight, according to medical guidelines.
Alternatively, you are not diabetic but have a BMI (Body Mass Index, a measure of body fat based on height and weight) of 27 or higher, meaning you are overweight, or a BMI of 30 or higher, meaning you are obese.
You have at least one weight-related health issue, such as hypertension (high blood pressure), dyslipidemia (unhealthy levels of fats in the blood), or obstructive sleep apnea (a condition where breathing repeatedly stops and starts during sleep).
Or, you have established cardiovascular disease, which refers to problems with the heart or blood vessels, such as a previous myocardial infarction (heart attack), a stroke (sudden brain damage caused by blood flow issues), or peripheral arterial disease (poor blood flow to the limbs).
You must have been taking aspirin alone or aspirin combined with clopidogrel (a blood-thinning medication) for at least 14 days before joining the study.
You are a man or a woman between the ages of 45 and 75 years old.
You are willing to provide consent, follow the study treatments, and attend all scheduled appointments and tests.
Women who can become pregnant must agree to use highly effective contraception (methods to prevent pregnancy) from the start of the study until at least 8 weeks after the final dose of the study medication.
You must have had blood tests within the last 2 months that show your levels for hemoglobin (a protein in red blood cells), eGFR (a measure of how well your kidneys are filtering blood), AST, and ALT (two types of enzymes that indicate liver health).

Who cannot join the trial?

18 criteria

You had a myocardial infarction (heart attack), stroke, or were hospitalized for unstable angina pectoris (severe chest pain caused by reduced blood flow to the heart) within the last 90 days.
You experienced a transient ischemic attack (a temporary period of symptoms similar to a stroke) or any other thrombosis (a blood clot in an artery or vein) in the last 90 days.
You have a history of or currently have pancreatitis, which is inflammation of the pancreas.
You have had major surgeries on your stomach, such as gastrectomy (removal of part or all of the stomach), sleeve gastrectomy, or gastric bypass surgery, as these may change how your body absorbs the study medicine.
You have proliferative retinopathy or maculopathy (eye conditions that damage the retina or the central part of the retina) that require urgent treatment.
You have had a malignant neoplasm (cancer) in the last 5 years that required chemotherapy, surgery, radiation, or palliative therapy (treatment to relieve symptoms rather than cure the disease).
You or a close family member (such as a parent or sibling) have a history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (a specific type of thyroid cancer).
You are currently participating in another clinical trial or finished using an experimental medicine or device less than 30 days ago.
You have any medical condition that would make it difficult for you to follow the rules and steps of the study.
You are pregnant, breastfeeding, or planning to become pregnant during the study.
You are taking anticoagulant agents (blood thinners) or antiplatelets (medicines that prevent blood cells from sticking together) other than aspirin or the combination of aspirin and clopidogrel.
You have used DPP-4 inhibitors, GLP-1 RA, or pramlintide (types of diabetes medications) within 30 days before the screening.
You have a known or suspected hypersensitivity (allergic reaction) to semaglutide or similar products.
You are currently using or expect to use steroids or non-steroidal anti-inflammatory drugs (medicines used to reduce swelling and pain) on a long-term basis.
You have been diagnosed with type 1 diabetes or have a history of ketoacidosis (a serious complication of diabetes where the blood becomes too acidic).
You have severe heart failure, specifically NYHA Class 4, which is the most advanced stage where symptoms occur even at rest.
You have end stage renal impairment (severe kidney failure), which is measured by an eGFR (a calculation of how well your kidneys filter blood) of less than 15ml/min, or if you require hemodialysis or peritoneal dialysis (treatments to clean your blood when kidneys fail).
You have known severe liver disease.

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Investigated drugs

Semaglutide
is the medication being tested in this study. It is available in two forms: an injection given under the skin or a tablet taken by mouth. This medication is used to manage blood sugar levels and assist with weight management.
Clopidogrel
is a medication used in this study as a comparison. It is taken as a tablet and works to prevent blood cells called platelets from sticking together, which helps reduce the risk of blood clots.
Acetylsalicylic acid
is a medication used in this study as a comparison. Commonly known as aspirin, it is taken as a tablet and is used to help prevent blood clots by making the blood less likely to clump together.

What is already known about the treatment

Semaglutide
This medication is used to treat type 2 diabetes and to manage weight in individuals with obesity or overweight. It is available as either a weekly subcutaneous injection or as a daily oral tablet. At a molecular level, it works by mimicking a natural hormone that stimulates insulin production and helps regulate appetite. It belongs to a class of drugs known as glucagon-like peptide-1 receptor agonists.
Clopidogrel
This medication is an antiplatelet drug used to reduce the risk of heart attacks and strokes in patients with cardiovascular disease. It is administered orally in the form of tablets. The drug works by preventing blood cells called platelets from sticking together and forming dangerous clots in the arteries. It is classified as a P2Y12 receptor antagonist.
Acetylsalicylic acid
Commonly known as aspirin, this medication is used to prevent blood clots and reduce the risk of cardiovascular events. It is taken orally, often in a special tablet form designed to protect the stomach. It works by blocking specific enzymes that allow platelets to clump together, thereby thinning the blood. It is pharmacologically classified as an antiplatelet agent and a nonsteroidal anti-inflammatory drug.

Investigated diseases

Diabetes Mellitus
This is a condition that affects how the body uses sugar, which is a primary source of fuel for cells. It occurs when the body cannot produce enough insulin or cannot effectively use the insulin it makes. Over time, high blood sugar levels can lead to various health complications. The condition is often managed by monitoring glucose levels and adjusting lifestyle or medications.
Cardiovascular disease
This refers to a group of disorders that affect the heart and blood vessels. These conditions can involve the arteries, veins, or the heart muscle itself. They often progress as a result of buildup in the blood vessels or changes in how the heart functions. Common forms include issues with blood flow and heart rhythm.
Overweight
This is a condition where a person has an excess amount of body weight relative to their height. It is commonly measured using the body mass index, which serves as a screening tool. This state can lead to increased tension on the body's systems. It often serves as a precursor to more significant weight-related health issues.
Obesity
This is a medical condition characterized by an excessive accumulation of body fat that may impair health. It is defined by a body mass index that reaches a specific higher threshold. The condition can develop over time due to various lifestyle and biological factors. It is often associated with other metabolic and physical health challenges.