Study Information
This brochure contains information about the MARITIME-1 Study for people with 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. A clinical trial is a type of clinical study. Clinical trials 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 before it can be prescribed to people. We need people to take part in these clinical trials to help develop new medicines. People may experience overweight or obesity in different ways. We work to make sure our studies include people of different races, ethnicities, ages, and backgrounds. This helps us to see how the investigational medicine works for different people.
About the MARITIME-1 Study
In this study, we will be working together to see if an investigational medicine is safe to use, and whether it can help people with overweight or obesity to lose weight and manage weight-related conditions. The investigational medicine is a monthly injection that is given subcutaneously (under the skin). Increasing physical activity and reducing the number of calories eaten does not necessarily lead to a reduction in weight for all individuals. As obesity continues to increase, this is a concern, as some diseases are known to occur more often in people with overweight or obesity. These include:
- diabetes
- heart and vascular conditions
- sleep disorders
It has been shown that reducing weight can help manage weight-related conditions.
What will this study involve?
If you take part, you will be in the MARITIME-1 Study for up to 88 weeks (a little under 2 years). You will receive either the investigational medicine or a placebo, which contains no actual medicine (together both are called the “study drug”). A placebo looks the same as the investigational medicine.
The study is made up of 3 parts
Screening period
(up to 4 weeks)
- You will visit the study center to see whether you are a good fit for the study and whether you want to take part.
Study treatment period
(about 72 weeks, or 16.5 months)
- You will visit the study center about 20 times for study assessments.
- You will receive the study drug every 2 weeks for the first month. After that, you will receive the study drug once every 4 weeks.
Follow-up period
(about 12 weeks, or 3 months)
- You will visit the study center once more for study assessments.
Who can take part?
You, or someone you care for, may be able to take part
if you/they:
• are 18 years of age or older,
• have obesity, or have overweight and are living with a weight-related condition, such as hypertension, dyslipidemia, sleep apnea, cardiovascular disease, or metabolic dysfunction-associated steatotic liver disease.
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.
3500 participants
How do I get more information?
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
