An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome

CORT125134-452

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.

2018-05-07

2025-12-01

2025-12-01

Early phase I

75

Inclusion Criteria: * Major Inclusion Criteria: * Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule. * According to the Investigator's opinion will benefit from continuing treatment with relacorilant Exclusion Criteria: * Major Exclusion Criteria: * Premature discontinuation from a relacorilant parent study. * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism * Has poorly controlled hypertension * Has Stage ≥ 4 renal failure

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2024-05-03