AuthorisedTherapeutic confirmatory (Phase III)Interventional

Impact of Oral Semaglutide on Platelet Reactivity in Patients with Diabetes Mellitus or Overweight with High Risk or established Cardiovascular Disease: the SEMA-PLAT Study

This study is investigating how two new medications, Rybelsus and Wegovy, affect blood platelets. Platelets are tiny cells that help your blood clot, but if they become too 'sticky', they can sometimes lead to serious health problems like heart attacks or strokes, especially in people with diabetes, those who are overweight, or those who already have heart disease. The main goal is to see if these medicines change how active or 'sticky' your platelets are. We're also checking other things like inflammation and how your blood vessels are working. This research is important because it could help us understand more about how these common medications affect your heart health beyond just managing blood sugar or weight.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali

Enrolment target

212

Start

23 Apr 2026

Diabetes Mellitus Cardiovascular disease Overweight (BMI ≥27 kg/m²)Obesity (BMI≥30kg/m2)

What is this study about?

This study, called SEMA-PLAT, is like a detective story trying to understand more about how certain new medicines work in your body. We are focusing on two particular medications: Rybelsus, which is a tablet, and Wegovy, which is an injection. Both of these medicines are used to help people with conditions like type 2 diabetes or those who are overweight.

The main thing we want to find out is how these medicines affect tiny parts of your blood called platelets. Platelets are like little building blocks that help your blood clot, which is important when you get a cut. However, sometimes, especially in people with diabetes, those who are overweight, or who have heart and blood vessel problems, platelets can become too 'sticky' or active. This stickiness can unfortunately lead to serious issues like heart attacks or strokes.

So, the study will compare what happens to platelets when people take these new medicines, and we'll also be looking at other important aspects of your health. This includes checking for signs of inflammation in your body (which is your body's response to injury or infection), and how well your blood vessels are working. By doing this research, we hope to gain a much clearer picture of how Rybelsus and Wegovy can impact your heart and blood vessel health, beyond just helping with your blood sugar or weight.

Key takeaways

This study investigates how Rybelsus and Wegovy affect blood platelets.
It aims to understand potential impacts on heart and blood vessel health.
Participants will have diabetes, be overweight, or have existing heart disease.
Blood tests will monitor platelet activity and other important health markers.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older. Both men and women can take part.

You might be able to join if you have been diagnosed with diabetes, or if you are overweight (meaning your Body Mass Index, or BMI, is 27 or higher) or living with obesity (BMI 30 or higher). You also need to have heart or blood vessel disease, or be at a high risk of developing it.

There will be other detailed health checks to make sure the study is safe and appropriate for you, so it's always best to discuss this with your doctor.

Quick self-check

Are you 18 years old or older?
Do you have diabetes or are you overweight/living with obesity (BMI 27 or higher)?
Do you have heart or blood vessel disease, or are you at high risk for it?
Are you able to attend clinic visits for blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be given one of the study medications: either Rybelsus tablets or Wegovy injections, alongside other commonly used heart medications like Clopidogrel or Aspirin. You would have several visits to the clinic where medical staff will take blood samples at different times to check how your platelets and other health markers are responding to the medication. These blood tests help us understand how the medicines are affecting your body at different stages. The team will explain the full schedule of visits and tests if you are interested in joining.

Potential risks and benefits

Taking part in a study like this could potentially provide you with early access to new treatments and contribute to our understanding of these medications for future patients. However, there are also potential risks involved, such as experiencing side effects from the study medications, or discomfort from blood tests. You will be closely monitored by medical professionals throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What are platelets and why are they important?

Platelets are tiny blood cells that help your blood clot when you get a cut. In some conditions, they can become too active and potentially cause problems like blood clots in your heart or brain.

What are Rybelsus and Wegovy?

These are prescription medicines used for managing blood sugar in people with type 2 diabetes (Rybelsus) and for weight management (Wegovy). They help your body in different ways.

Will I know which medicine I am taking?

The study design will determine this. Sometimes participants know, and sometimes it's like a scientific 'flip of a coin' to ensure fair results. The study team will explain this to you.

What kind of tests will I have?

You'll have blood tests taken at different times to measure how your platelets are working and to check for other health markers like inflammation. These are standard blood tests.

How long will the study last?

The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you by the study team before you decide to join.