Purpose of the

The purpose of the GRACE Study is to evaluate the effectiveness (benefits) and safety (side effects) of an investigational study medicine, relacorilant, in treating participants with endogenous Cushing syndrome, also known as hypercortisolism. All eligible participants will receive the investigational study medicine.

Who May Qualify

Eligible participants must meet the following criteria, in addition to other criteria:

  • Male or female between the ages of 18 and 80, inclusive
  • Diagnosed with endogenous Cushing syndrome
  • Willing and able to comply with the study instructions

There are additional eligibility requirements that the study doctor can explain to you.

Study Schedule

The GRACE Study is divided into two parts: (1) the open-label phase and (2) the randomized-withdrawal phase. All study participants will be in the first part, but only some will be eligible to continue to the second part. Participation in the study could last up to 46 weeks and include up to 13 visits to the research site.

Screening: After you consent to participate in the study, you will need to attend a screening visit where your study doctor will perform tests and procedures to confirm your eligibility to take part in the study. The screening portion of the study may last up to six weeks.

First part (open-label phase): If you qualify based off the study criteria, you will receive the investigational study medicine and be in this part of the study for up to 24 weeks and will need to visit the research site approximately 10 times.

Second part (randomized-withdrawal phase): If you qualify to enter the second part, you will have a 50/50 chance of continuing to receive the investigational study medicine or receive the placebo and will remain in the study for an additional 12 weeks and need to visit the research site approximately three more times.

Long-Term Extension Study: If you complete the study, and your study doctor determines that you have benefited from the investigational study medicine, you will have the option to continue receiving treatment in the long-term extension study.

You may 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.

Study Design

For more information about the GRACE Study, download the brochure and fact sheet.

Find a participating research site