Why is the Sponsor conducting this study?
The purpose of this study is to find out whether the investigational study drug, relacorilant, is safe and effective in treating participants with Cushing syndrome. The study will look at how well relacorilant controls blood glucose and blood pressure, which are commonly elevated in participants with Cushing syndrome. This study will also perform pharmacokinetic (PK) testing – that measures your blood levels while taking the study drug to understand how it is absorbed, broken down and removed by your body.
What do we know about the drug being studied?
Relacorilant is currently being tested to evaluate the safety (side effects/risks) and efficacy (benefits), so its use in for the treatment of Cushing syndrome is experimental. It has not been approved in any country. Therefore, its effectiveness is unproven and relacorilant is considered an investigational study drug. As a participant with Cushing syndrome, your body has abnormal cortisol levels above the normal range. Cortisol acts by binding with the cortisol receptor in many tissues of the body. Relacorilant works by also binding with the cortisol receptor, thereby decreasing the effects of too much cortisol. Relacorilant doesn’t interact with any other hormonal receptor in your body other than the cortisol receptor.
1. Male or female, 18 to 80 years of age, inclusive
2. Has a confirmed diagnosis of endogenous Cushing syndrome
3. Meets at least one of the following criteria:
- Has Type 2 diabetes mellitus
- Has impaired glucose tolerance
- Has hypertension
1. Has non-endogenous source of hypercortisolemia
2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
3. Has poorly controlled hypertension
4. Has poorly controlled diabetes mellitus
5. Has severe renal insufficiency
Detailed eligibility will be reviewed when you contact the study team.