FAQs
The first step is discovering and developing an investigational medicine to study. After that, clinical studies show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like a potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment already approved and used for treatment. They compare it to current treatments, if available, to find out if the potential treatment is better.
Am I Eligible?
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Clinical studies are 100% voluntary. You can stop at any time.
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A clinical research study is a medical research study in people. The potential treatment or device being studied only enters a clinical study after researchers test it in the laboratory. If it looks promising, scientists carefully test and collect data about the potential treatment through clinical studies. A clinical study helps us learn how an investigational treatment works in the body. Clinical studies must be reviewed and approved by a regulatory agency to ensure the health, privacy, and safety of study participants. In the United States, it’s the Food and Drug Administration (FDA). In Europe, it’s the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational treatment for doctors to prescribe.
The first step is discovering and developing an investigational medicine to study. After that, clinical studies show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like a potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment already approved and used for treatment. They compare it to current treatments, if available, to find out if the potential treatment is better.
For more information regarding the study, visit the About COURAGE section.
About the COURAGE Study
To see if you can join the study, take our questionnaire in the Am I Eligible? section.
Am I Eligible?
About 600 people worldwide are expected to participate in the study.
If you decide to join the COURAGE study, you will be asked to attend all study visits and keep the study team informed about your contact information and which medications you are taking. There are more responsibilities when taking part in COURAGE, which you will learn more about if you join. Please talk to the study team about any questions or concerns you may have.
The study will last up to 20 months (a little under 2 years).
You might benefit from extra health check-ups on top of your regular medical care. You will also help us increase our medical understanding of obesity, which may benefit others in the future with this condition.
The Informed Consent Form talks about all known risks. Before starting a clinical study, you must sign the document. Signing it means you agree to participate in the research study. The study staff will walk you through the study schedule and design. Ask questions so you are comfortable moving forward.
Clinical studies are 100% voluntary. You can stop at any time.
The study is taking place in the United States and Puerto Rico.