Novo Nordisk Cardiovascular Study

Dear Potential Participant:

We are pleased to inform you of an upcoming research study 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.

Your participation in this study would be voluntary and could be as long as 5 years, or until the trial has reached the necessary outcome events, as this study is event driven.

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

At the beginning, visits will be occurring on a monthly basis and then less frequently (approximately every 13 weeks) for the remainder of the study, for a total of up to 26 visits. All visits will be at the MUSC campus in downtown Charleston. If you cannot commit to attending visits over five years, this study is not for you.

There are several potential benefits of taking part in SELECT. For example you can:

• Take a more active role in your own healthcare
• Get regular expert medical care at healthcare facilities
• Have additional talks with study staff to discuss healthy lifestyle choices
• Help others by contributing to medical research

There may be some potential downsides to taking the study medicine:

• 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

To be eligible for this study, participants must have existing cardiovascular disease as documented by past heart attack or stroke of current peripheral arterial disease. To see if you might meet eligibility criteria, please review the attached list of statements. You must be able to answer true to all of the items on the attached list. Not all eligibility requirements are listed in the space available here, and some are based on information gathered at the screening visits and from lab work, so even if you can say “True” to all the statements, there is no promise you will qualify for this study.

Sincerely,

Patrick O’Neil, Ph.D.
Professor, Director, Weight Management Center

Robert Malcolm, M.D.
Professor

I may be eligible for enrollment in this study if I can answer true to each and every one of the following criteria:

1. I am at least 45 years old.
2. I have cardiovascular disease as shown by at least one of the following:
   1. prior heart attack (myocardial infarction
   2. prior stroke (ischemic or hemorrhagic stroke)
   3. symptomatic peripheral arterial disease
3. I weigh at least the following minimum for my height:

** This criterion is very important. If you are not sure how to read this chart, please call 843-792-5428 (Alternate is 792-2273) for assistance.

There is no upper limit of weight in this study. If in doubt, or if you are shorter or taller than heights included on this chart, please call 843-792-5428 (Alternate is 792-2273) for assistance.

4. Within the last few months, I have not incurred a heart attack, stroke, been hospitalized for unstable angina pectoris or a transient ischemic attack.
5. To my knowledge, I do not have diabetes of any type.
6. Within the last three months, I have not taken any glucose-lowering agents (diabetes medicine).
7. Within the last three months, I have not taken any glucagon-like peptides (GLP-1) like liraglutide, exendatide or semaglutide
8. I do not have a history of pancreatitis.
9. I do not have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.
10. I do not have end stage renal disease and do not require chronic or intermittent hemodialysis or peritoneal dialysis.
11. To my knowledge, I have not had cancer of any kind (except for basal cell or squamous cell skin cancer).
12. I have not had a severe psychiatric disorder over the last few years.
13. If female, I am not currently pregnant or nursing, nor am I planning to become pregnant over the next five years.
14. If female:
    
    1. I am not able to become pregnant, or
    2. I am able to become pregnant, but I am willing to use an acceptable means of contraception over the next five years.
15. I am willing to attend frequent visits to the MUSC campus in downtown Charleston over the next several years.
16. I am willing to participate in a study that requires me to inject myself with study medicine on a weekly basis.
17. I am willing to have my blood drawn multiple times over the next five years.
18. Within the last month, I have not participated in any clinical trial.
19. I am able to speak and read English.
20. I am able to follow instructions.
21. I know that there are other criteria that might not be included in this list. (If you have any doubts about conditions or medications, please call 843-792-5428 [Alternate is 792-2273] and leave a message if necessary.)

If, after reading all of the material in this packet, you think you may be eligible for consideration, please call 843-792-5428 (Alternate is 792-2273) to register for an orientation session. If you have any concerns about whether you qualify, please leave a message so that we can get back to you.