The SELECT Trial

Have you had a heart attack or stroke?

You may be eligible for a new clinical study, testing an investigational drug for its ability to reduce cardiovascular events

Participating in a clinical study can improve future treatment options for you and other people with cardiovascular diseases

Research has shown that treatment with semaglutide may reduce the risk of stroke and heart attack in people with type 2 diabetes. In a study called SELECT, we will investigate to see if semaglutide reduces the risk of cardiovascular events such as heart attack and stroke in people with overweight or obesity and established cardiovascular disease.

You may qualify to participate in the SELECT study if:

• You have had a brain attack (stroke), or heart attack (myocardial infarction), or have poor circulation (peripheral arterial disease)
• You are 45 years old or older
• You are living with overweight or obesity
• You are able to attend regular clinic visits and receive phone calls over a period of 3–5 years

What is a clinical study?

A clinical study is a research study conducted with human volunteers to answer specific health questions. Clinical studies are carefully conducted and monitored to find better ways to prevent, diagnose or treat medical conditions.

Who can participate?

Some studies involve people with a particular medical condition, others involve healthy volunteers. Each study has a set of rules about who can participate, based on things like current medical conditions, current treatment or age.

What is informed consent?

If you decide to take part in a clinical study, you will be given a document called an informed consent form which explains the study to you. Your study doctor or study staff will go through this document with you and answer any questions you may have. You must sign the informed consent form to confirm that you have decided to take part in the study.

The informed consent form is not a contract, and you may withdraw from the study at any time.

Benefits of participating in a clinical study

There are several potential benefits to taking part in clinical studies. For example you can:

• Take a more active role in your own healthcare
• Gain access to new treatments before they are widely available
• Get expert medical care at leading healthcare facilities
• Help others by contributing to medical research

How is my safety protected?

The health and safety of all participants is the highest priority in a clinical study. Research teams follow strict ethical and scientific rules, all of which must be approved by your country’s authorities and an independent ethics committee. You should contact the study staff immediately if you have any safety concerns.

What happens during a clinical study?

The clinical study process depends on the type of study being conducted. The doctor or study staff will explain the process to you fully before you start.

Participation in a clinical study often means more clinical visits or medical tests than you would normally have. The study staff may also call you between visits.

What is a placebo?

A placebo looks the same and is given the same way as the active treatment, but does not have any effect on the body. In clinical studies, treatments are often compared with placebos to understand the benefit of the new medicine compared with no medicine. Placebos are not harmful in any way.

What is semaglutide?

Semaglutide is a medicine which is similar to a natural hormone called glucagon-like peptide-1 (GLP-1). GLP-1 is produced in the body after eating a meal. Medicines belonging to the GLP-1 class are normally given as an injection and some are already available on the market to treat diseases like type 2 diabetes & obesity.

Studies of semaglutide suggest it has beneficial effects on the cardiovascular system, including reducing blood pressure and improving levels of fat in the blood.

Possible treatment effects of semaglutide

• Energy intake: Semaglutide can reduce feelings of hunger which means you may eat less food. This may help to reduce your body weight, when combined with a healthy diet and exercise.
• Effect on plaques: Semaglutide has been shown to stop the progression of plaques in blood vessels in studies of animals. Human studies have shown reduction of death, heart attacks and strokes.
• Blood sugar: If your blood sugar levels are too high, semaglutide may help to lower them.

Most common side effects

Not everyone will experience side effects, but if you do, you should let the study staff know. The most commonly reported side effects are stomach and gut problems. These may include feeling sick (nausea) or being sick (vomiting), diarrhea, upset stomach, low appetite, pain in stomach area and constipation. These side effects are usually mild or moderate.

These side effects are most likely to happen when you first start taking the study medicine and are likely to decrease or disappear entirely as you continue through the study. To decrease risk of having stomach and gut side effects, you will be started on a low dose of the study medicine, which will be increased gradually.

How can I get involved?

If you meet the listed eligibility criteria, and would like to learn more, we’d love to hear from you! Please call 301-770-7373 for more information.