FAQs

What is a clinical research study?

Clinical research studies, also called clinical trials, test new medicines and other treatments to be sure that they successfully improve people’s health and are safe to use. Before any clinical research study can begin, a review board evaluates the medicine or treatment to be sure it is safe and ethical for patient use. Once the study is over, if the medicine or treatment is judged to be safe and effective, a government agency, like the Food and Drug Administration (FDA) in the United States, decides if the medicine or treatment can be prescribed to patients.

Before deciding to participate, you should make sure you understand the potential side effects, risks, and benefits of being in the study. The study doctor will explain these to you. If there is anything you do not understand, you are encouraged to ask the study doctor.

What are the benefits of participating in a clinical research study?

There are a few benefits of taking part in a clinical research study. One benefit of this study is that, if you qualify, you will have access to the investigational study medicine before it is widely available—and at no cost to you. You can also play a more active role in your healthcare and receive more frequent checkups and other medical care than you might normally. Finally, your participation could help others who experience the same symptoms and challenges that you do, which can give you a sense of pride and accomplishment.

Who can participate?

The Grace Study is for adults 18 to 80 years of age with endogenous Cushing syndrome. There are additional criteria for study participation that a study team member can go over with you.

What should I expect if I decide to participate in the Grace Study?

Before you can take part in the Grace Study, you will first need to attend a screening visit for initial tests and assessments to see if you are eligible to participate.

After all necessary tests and assessments have been completed, you will enter the study and receive the investigational study medicine for up to 26 weeks. The research staff will then perform another set of tests to determine if you are eligible to continue study participation. Those who are eligible will have a 50/50 chance of continuing to receive the investigational study medicine and will remain in the study for an additional 12 weeks.

How long will study participation last?

Participation in the study could last up to 48 weeks. This includes six weeks for screening, up to 26 weeks for the first part of the study (which is the open-label phase), up to 12 weeks for the second part (the randomized-withdrawal phase), and four weeks for the follow-up.

You may also be asked to return to the research site for extra visits at any time during the study if the study doctor decides that extra assessments are needed for your safety.

Will everyone in the study receive the investigational study medicine?

Yes. If you qualify for and enroll in the study, you will receive relacorilant, the investigational medicine, during the open-label phase for up to 26 weeks. Then, if you’re eligible to remain in the study, there is a 50/50 chance that you will either continue to receive relacorilant or be assigned the placebo (inactive medication).

Will I have to pay to participate?

No. Those who qualify will receive the investigational study medicine, study-related medical exams, and study-related laboratory tests at no cost.

Can I leave the study if I change my mind?

Participation in any clinical research study is completely voluntary, and you may choose to leave the study at any time for any reason. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely.

Learn more about the Grace Study