A Phase 2 interventional study of relacorilant in Cushing Syndrome, sponsored by Corcept Therapeutics. Active, not recruiting at 48 sites in 10 countries. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Corcept Therapeutics · Phase 2, Interventional, and Treatment
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
This study's enrollment of 125 is above the median of 44 across 58 interventional studies indexed under Cushing Syndrome.
Browse Cushing Syndrome studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 3 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 9 (28%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Major Inclusion Criteria:
Exclusion Criteria:
Major Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: relacorilant
CORT125134 is supplied as capsules for oral dosing.
Also known as: CORT125134
Long-term safety of relacorilant
Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher
Time frame: 36 months
Number of patients with one or more hematology laboratory abnormality by severity grade
The hematology laboratory abnormalities to be assessed are hemoglobin decreased, hemoglobin increased, platelet count decreased, white blood cell count decreased, leukocytosis, eosinophilia, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4 or higher) criteria.
Time frame: Up to Month 99
Number of patients with one or more clinical chemistry laboratory abnormality by severity grade
The clinical chemistry laboratory abnormalities to be assessed are hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hypocalcemia, hypercalcemia, creatine increased, hypoglycemia, hyperglycemia, blood lactate dehydrogenase increased, hypomagnesemia, hypermagnesemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia, creatine phosphokinase increased, blood bilirubin increased, and hyperuricemia. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the CTCAE, version 4 or higher criteria.
Time frame: Up to Month 99
Change from Baseline in oral body temperature
Time frame: Baseline and up to Month 99
Change from Baseline in respiratory rate
Time frame: Baseline and up to Month 99
Change from Baseline in blood pressure
Systolic and diastolic blood pressure will be assessed.
Time frame: Baseline and up to Month 99
Change from Baseline in heart rate
Time frame: Baseline and up to Month 99
Change from Baseline in electrocardiogram (ECG) parameters
12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer. The parameters to be assessed are PR interval, QRS interval, QT interval, RR interval, QTcF interval, and QTcB interval.
Time frame: Baseline and Month 3
Change from Baseline in ECG ventricular rate
12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer.
Time frame: Baseline and Month 3
Change from Baseline in the longest vertical diameter of pituitary tumors as determined with magnetic resonance imaging (MRI)
Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A computed tomography (CT) scan can be used in patients for whom MRI is contraindicated.
Time frame: Baseline and up to Month 72
Change from baseline in the volume of pituitary tumors as determined with MRI
Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A CT scan can be used in patients for whom MRI is contraindicated.
Time frame: Baseline and up to Month 72
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Relacorilant