Objectives:

The purpose of this study is to evaluate a new investigational medication for patients who have Cushing syndrome due to the body’s production of too much cortisol.

This study is an open label study. That means both the health providers and the participants in the study are aware of the drug or treatment being given.

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.

The multicenter study will be conducted in the United States and in Europe.

Eligibility criteria:

Allowed

1. Diagnosis of Cushing syndrome caused by the body’s production of too much cortisol (not caused by steroid medication)
2. Requires medical treatment for Cushing syndrome
3. Meets at least one of the following criteria:
1. Has type 2 diabetes or impaired glucose tolerance (has a high blood sugar level)
2. Has high blood pressure

Exclusion criteria:

Not Allowed

1. Diagnosis of Cushing syndrome caused by steroid medication
2. Poorly controlled blood pressure
3. Severe kidney disease

These and other eligibility criteria are best reviewed with a doctor who is participating in the study. You can also get more detailed eligibility information about the study by visiting clinicaltrials.gov. (NCT02804750) or the Pre-screener.

Study Details:

• 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

Study Locations:

The study is currently taking place in the United States, United Kingdom, Netherlands, Italy, and Hungary.

Additional information on the study is available from:

• NIH (gov)
• CORT125134 Pre-screener

Study sponsor: Corcept Therapeutics

For more information, please contact:

Andreas G. Moraitis, MD

tel: +1 (347) 754-1993 or [email protected]