Clinical Trial for levoketoconazole

This trial is testing the safety and effectiveness of a new investigational drug for the treatment of Cushing’s Syndrome. Under the supervision of qualified physicians, cortisol levels and symptoms of Cushing’s Syndrome will be closely followed along with any signs of side effects.

The investigational drug (levoketoconazole) is administered by mouth in the form of tablets.

This is a phase 3 trial.

There will be up to 90 participants worldwide in this trial. This page lists U.S. sites only.

Eligibility criteria

Participants must:

be at least 18 years old
have been diagnosed with endogenous Cushing’s Syndrome by a medical professional (endogenous means that it is caused by your body producing more cortisol than it needs, not caused by the use of steroid medications)
Participants must not:

have been treated with radiation for their endogenous Cushing’s syndrome in the past 4 years
be currently using weight loss medication
have a history of drug or alcohol abuse
have been diagnosed with uncontrolled hypertension, some forms of cancer, adrenal carcinoma, Hepatitis B / C, or HIV
Note: The study doctor will ultimately determine your eligibility
Study details

The length of this study and the number of study visits will vary from patient to patient. It has approximately 13 to 27 visits to the study site spread out over one to one and a half years. This study will enroll approximately 90 participants.

A placebo isn’t being used for this trial. All study participants will receive the investigational drug.

The sponsor of this trial is Cortendo AB.

The results of this trial are intended to be published. Individual patient information will not be included.

Reasonable travel expenses may be reimbursed.

This is a global study which will be conducted in multiple countries, with several sites in the US.

This information is intended for US audiences only.

Find out if you’re eligible here.

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