Treatment of Endogenous Cushing’s Syndrome Version 4.0
Research type
Research Study
Full title
Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome
IRAS ID
205783
Contact name
Tara Kearney
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Eudract number
2016-000899-23
Clinicaltrials.gov Identifier
128625, IND Number
Duration of Study in the UK
1 years, 2 months, 13 days
Research summary
The study drug CORT125134, is a potent, selective glucorticoid receptor (GR) antagonist (competitor) being developed for the treatment of Cushing's syndrome. GR antagonism is a proven mechanism of action for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with Cushing's syndrome.
The main purpose of this study is to compare the safety of two different groups of study drug doses. The second aim of the study is to find out how well the study drug reduces the adverse effects of high levels of cortisol in the patients body by seeing the effects on their blood pressure if they have hypertension or their glucose control if they have diabetes.This study will enroll about 30 patients in approximately 15-20 different sites in Europe and the US. Participation will last around 22 weeks and there will be 9 scheduled visits to the clinic. Most test and assessments are routine in patients with endogenous Cushing's syndrome; however there will be tests that are not routine.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0558
Date of REC Opinion
16 Aug 2016
REC opinion
Favourable Opinion