What is the purpose of the COURAGE clinical research study?

If you are living with obesity, please know that you are not alone in your medical journey. The World Health Organization reports that in 2022, 890 million adults worldwide were living with obesity. There are many health consequences associated with obesity including diabetes, high blood pressure, heart disease, stroke, and some cancers.

Currently, we are working on developing potential treatments for obesity. COURAGE is a clinical research study that aims to see how safe and effective the study drugs are in weight reduction and fat mass loss when combined with an approved weight loss medication (semaglutide).

These study treatments are not approved to treat obesity.

What are the study drugs?

Study drug:
This treatment includes 2 different study drugs being developed for the treatment of obesity and potentially helping with muscle preservation.

Semaglutide:
A drug that is approved in the U.S. for weight loss. You and all the other participants will receive this drug for 26 weeks.

Placebo:
A placebo looks like a drug but does not contain any real medicine. Researchers can tell whether a study drug is effective by understanding if it works better than a placebo.

Study drug:
This treatment includes 2 different study drugs being developed for the treatment of obesity and potentially helping with muscle preservation.

Semaglutide:
A drug that is approved in the U.S. for weight loss. You and all the other participants will receive this drug for 26 weeks.

Placebo:
A placebo looks like a drug but does not contain any real medicine. Researchers can tell whether a study drug is effective by understanding if it works better than a placebo.

There are two treatment periods, each lasting 26 weeks. For the first treatment period, you will be randomly assigned to one of four study treatment options involving semaglutide in different combinations with the study drugs and placebo. You will have an equal opportunity to receive any one of these four options. After 26 weeks, treatment with semaglutide will be stopped and you will receive either study drug A or a placebo for an additional 26 weeks. You will have an equal opportunity to receive either study drug A or a placebo for this second treatment period. During the entire study, your study physician, study team, and you will not know which treatment you are receiving.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the COURAGE study. You may leave the study at any time without it affecting your regular health care.

If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures. These include physical exams, electrocardiograms (ECGs, a heart test), dual X-ray absorptiometry (DXA), magnetic resonance imaging (MRI), ultrasounds, and echocardiograms (ECHO, imaging tests), vital signs, recording information about taking the study treatment, and answering questions about your health and quality of life. You will be given intravenous (into the vein) infusions of the study drug. You will be trained to give yourself doses of the study drug, which is a subcutaneous (under the skin) injection. You may also be asked to wear a device that measures your movement for a week at home. Your participation may last up to 20 months (a little under 2 years) with 18 study visits.

participation is 100% voluntary

participation may last up to 20 months

18 study visits

Qualified participants will be compensated for their participation after the completion of each visit. The study team will discuss all of this with you.

How can I take part?

If you wish to take part in COURAGE, you can fill in a short pre-screener questionnaire to see if you may be eligible.

What else should I know?

This study uses an investigational drug product of which the safety and efficacy has not been fully evaluated by Regulatory Authorities. As with all medicines, there are possible risks when taking the study drug. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study drugs may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.

You may benefit from additional check-ups on top of your regular care. There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Find a study site near you

To find out more about the COURAGE study, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.