SELECT is a clinical study involving approximately 17,500 people from 41 countries worldwide.
The SELECT study is being done to see if semaglutide can reduce the risk of cardiovascular events such as heart attack or stroke. Previous studies of semaglutide have shown that using semaglutide reduced the risk of cardiovascular events in some people with type 2 diabetes. Semaglutide is already approved in some countries at a lower dose, to treat type 2 diabetes. The SELECT study will examine the effect of semaglutide in people with established cardiovascular disease and obesity or overweight.
What are the benefits of taking part in SELECT?
Some potential benefits of taking part in SELECT include:
Take a more active role in your own healthcare
Get regular study related medical care at healthcare facilities
Help others by contributing to medical research
What are the potential downsides?
Some potential downsides to taking part in SELECT include:
You may experience side effects
Your study medicine may prove to be ineffective against cardiovascular problems
The study may require more of your time and attention than normal treatment, and may include extra clinic visits or more complex treatment requirements
You should tell your study doctor or the study staff about any side effects or health problems you have while taking part in the study, even if you do not think they are caused by the study medicine.
Before participating in a clinical study such as SELECT, the study doctor or study staff will provide both verbal and written information about the study, including comprehensive information of potential risks and benefits, to allow you to make an informed choice.
What will be required if I take part?
Initially, you will go through a screening process to ensure that you meet the criteria for being included in the SELECT study. If you do, your doctor will explain exactly what is expected of a study participant so you can make an informed decision. Participation in the SELECT study will include:
A once-weekly injection of the study medicine, prescribed by the study doctor
Attending regular study visits for study-related health checks
Regular contact with the study nurse or doctor throughout the study
Will I know if I have placebo or the real medicine?
SELECT is a ‘placebo-controlled’ study, which means half of the people in the study will be given a ‘dummy’ medicine called a placebo.
You will be randomly assigned to either the study medicine (semaglutide) or the placebo for the full length of the study.
You will not know which medicine you have and neither will your study doctor or the study team.
At the end of the study, you will be told which medicine you were given. You will also have an opportunity to see the results of the study.
How do my personal study results contribute to the final study results?
The information collected from you during the study is made anonymous, and entered into a database together with information from everyone else in the study. This is then analysed by doctors and scientists.
In order for the results to be meaningful, it is very important that everybody in the study continues until the end.
Do I need to attend every study visit?
The SELECT study will last for up to 5 years in order to get a clear picture of the effect of the study medicine over time. Attending regular study visits help us to understand the effect of the medicine, as well as giving you the opportunity to discuss any health-related questions or concerns with your study doctor.
You will be able to discuss the visits with your study doctor and organise times that work best with your schedule. You may also be able to phone the site for some visits, rather than attending in person.
Should I still go to my clinic visits if I stop taking the study medicine?
Even if you or your study doctor make the decision to stop taking the study medicine ahead of schedule, it is still very important for you to attend as many visits as possible until the end of the study! Valuable information can still be collected, and the study doctors can monitor your progress and health. Every patient’s information is important for the overall success of the study.
Will being in the SELECT study affect my other medicines?
You will continue to take any other prescribed medicines throughout the study as required.
What should I do if I become pregnant during the study?
You should not take part in this study if you are pregnant, breastfeeding, or planning to get pregnant. If you become pregnant during the study, you should stop taking your study medicine immediately and tell the study staff.
Is my personal and medical information confidential?
Your information is protected and treated with confidentiality, and will remain anonymous. In some countries, your personal information may be shared with a search agency, this will only happen if the study staff lose contact with you.
Will I get paid?
You will not receive any compensation for time spent at the clinic or for taking part in the study. You may be reimbursed for travel expenses. Please speak to the study staff about reimbursement.
Will I be helping others?
Choosing to take part in a clinical study is an important decision. By attending your study visits, you will help us to understand how safe the study medicine is, and how well it works. The results from this study will inform treatment for other people with cardiovascular illnesses.
