Home › Adrenal Insufficiency › NCT06430528

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

Who can join

Ages 18 to 75 · All sexes

Inclusion Criteria:

* Endogenous Cushing syndrome, either following surgery or not candidates for surgery
* Under consideration to receive osilodrostat as part of their clinical care
* Able to provide informed consent.

Exclusion Criteria:

* Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).
* A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.

About the study

The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach).

The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.

What is being tested

• Osilodrostat (drug)

Sponsor: University of Michigan · Participants: 12 · Started: Jul 19, 2024

Contact the study team

• Richard Auchus · Phone: 734-764-7764
• Eyad Alsafadi · Phone: 734-647-5661

Official record on ClinicalTrials.gov — NCT06430528

Locations in the U.S.

Conditions

• Adrenal Insufficiency
• Cushing's Syndrome

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.