A Phase III Study of Relacorilant for the Treatment of Cushing's Syndrome

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Full Title

Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant (WIRB)

Purpose

Cushing’s syndrome occurs when the adrenal glands produce too much of the stress hormone known as cortisol. This can be caused by a tumor which develops in the pituitary gland and secretes a hormone called adrenocorticotropic hormone (ACTH). Cushing’s syndrome can also be caused by an ACTH-secreting tumor elsewhere in the body, or by a tumor in the adrenal glands that makes cortisol.

Cortisol acts by binding with a particular receptor found in many tissues of the body. Relacorilant is a drug that works by also binding with the cortisol receptor, thereby decreasing the effects of too much cortisol. In this study, researchers are evaluating the effectiveness of relacorilant for controlling blood glucose and blood pressure, which are commonly elevated in people with Cushing’s syndrome.

All participants in this study will initially receive relacorilant. Then they will be randomly assigned to either continue receiving relacorilant or switch to a placebo (inactive drug), and researchers will compare the two groups. Relacorilant is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have Cushing’s syndrome with at least two clinical signs or symptoms.
  • Patients must have elevated blood glucose or blood pressure when they begin the study.
  • At least 4 weeks must pass since the last dose of another Cushing’s syndrome medication and receipt of relacorilant.
  • This study is for patients ages 18 to 80.

For more information about this study and to inquire about eligibility, please contact Dr. Eliza Geer at 646-608-3797.

Protocol

19-416

Phase

III

Investigator

Co-Investigators