This is a clinical trial for patients with Cushing syndrome
Cushing syndrome is a rare disorder caused by lengthy exposure to high levels of cortisol, a hormone naturally produced by the body. Cushing syndrome may result from too much cortisol being produced by the body or as a result of taking steroid medications.
This study is testing a new investigational medication for patients who have Cushing syndrome due to the body’s production of too much cortisol.
The investigational treatment (CORT125134) is taken once a day, orally (by mouth).
This is a Phase 2 trial. A Phase 2 trial means that the study drug has been taken before by healthy volunteers under supervision. In this current trial, the study drug is being used for the first time in patients with Cushing syndrome.
There will be 30 participants in this trial.
- Patients will be treated with the study drug for 12 weeks and will be evaluated every two weeks at the clinical research site
- Patients will be assigned to one of two groups, each with a two-step increase in medication doses; blood samples will be taken at every dose level to understand how the study drug is broken down and released from the body
- A placebo is not being used for this trial
- The sponsor of this trial is Corcept Therapeutics
- The results of this trial will be published
- All study related medications, analysis, hospital visits, and procedures are at no cost
- Diagnosis of Cushing syndrome caused by the body’s production of too much cortisol (not caused by steroid medication)
- Requires medical treatment for Cushing syndrome
Meets at least one of the following criteria:
- a. Has type 2 diabetes or impaired glucose tolerance (has a high blood sugar level)
- b. Has high blood pressure
Exclusion criteria:Not Allowed
- Diagnosis of Cushing syndrome caused by steroid medication
- Poorly controlled blood pressure
- Severe kidney disease
This study takes place in 5 countries: United States, United Kingdom, Netherlands, Italy, and HungaryNext Page