Study Information
This brochure contains information about the MARITIME-CV Study for people living with a cardiovascular condition and overweight or obesity. This information should help you decide whether you, or someone you know, may want to take part in the study.
What is a clinical study?
A clinical study is research involving people to understand human health and disease. Clinical studies look at specific medical treatments to see if they are safe and effective, and whether the benefits outweigh the risks. An investigational medicine must be studied in humans to make sure it is safe and effective before it can be prescribed to people.
People can contribute by joining clinical studies to help explore potential new treatment options and develop new medicines. We work to make sure our studies include people of different races, ethnicities, ages, and backgrounds as people may experience cardiovascular conditions in different ways. This helps us to see how the investigational medicine works for different people.
About the MARITIME-CV Study
In this study, we will be working together to see whether the investigational medicine is safe and can reduce the risk of cardiovascular events, such as heart attacks
and stroke.
The investigational medicine will be given as an injection just under the skin. It is not approved in any country for treating cardiovascular conditions (or any other use). It is only available in research studies like this one.
You will receive either the investigational medicine or a placebo – both will be called the “study drug.” A placebo looks the same as the investigational medicine but contains no actual medicine.
The study is divided into 2 parts that will be performed one after the other. The study duration will depend on how long it takes to gather the information needed to answer questions about the investigational medicine. Participants could be in the study for up to 5.5 years. Part 1 of the study is expected to last up to 3.5 years and Part 2 for 2 years.
Why is the MARITIME-CV Study important?
There is a need for new medications that can potentially reduce the risk of heart attacks and stroke through ways other than targeting the heart or blood vessels directly.
What will this study involve?
In addition to attending study visits and taking the study drug, participants will be expected to follow lifestyle and activity advice from a study team member.
Screening period
(up to 4 weeks)
- If you agree to take part, you will visit the study center to sign the informed consent form and to check whether you are a good fit for the study.
Study treatment period (2 parts)
(about 1–5 years)
- You will have regular visits to the study center for study assessments.
- In Part 1, you will receive the study drug once every 2 weeks in the first month and then once every 4 weeks as a monthly injection.
- Everyone who completes Part 1 will have the option to join Part 2 and receive the investigational medicine for 2 years. You will receive more information about Part 2 at the end of Part 1. If you decide not to enter Part 2, you will enter the follow-up period.
Follow-up period
(about 4 months)
- You will visit the study center once more for study assessments.
Who can take part?
You, or someone you know, may be able to take part if you/they:
- are 45 years of age or older
- are living with a heart and/or blood vessel (cardiovascular) condition
- have a body mass index (BMI) of 27 or more.
12,800 participants
What else do I need to consider?
- The study team will explain the possible benefits and risks of the study.
- You do not have to take part in the study if you do not want to.
- An Institutional Review Board (IRB)/Ethics Committee (EC) has reviewed this study. An IRB/EC protects the rights, safety, and well-being of participants.
How do I get more information?
To learn more about this study, please contact the study team using the information provided here. Study participation is voluntary. By contacting us, you do not have to take part in the study.
786-772-0510
