CORT125134 Study

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.

Study medication

The investigational treatment (CORT125134) is taken once a day, orally (by mouth).

Study details

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

Eligibility criteria:

Allowed

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 Hungary