A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome (NCT03697109) | Clinical Trial Compass
CompletedPhase 3
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
United States, Austria, Bulgaria152 participantsStarted 2018-11-15
Plain-language summary
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has a confirmed diagnosis of endogenous Cushing syndrome
* Meets at least 1 of the following criteria:
* Has Type 2 diabetes mellitus
* Has impaired glucose tolerance
* Has hypertension.
Exclusion Criteria:
* Has non-endogenous source of hypercortisolism
* Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
* Has poorly controlled hypertension
* Has poorly controlled diabetes mellitus
* Has severe renal insufficiency.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.
Timeframe: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
2
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
Timeframe: OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase