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

Recruiting now

Conditions studied: Endogenous Cushing Syndrome, Adrenal Insufficiency, Hypercortisolism

In brief

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.

Key facts

Study ID

NCT06430528

Run by

University of Michigan

People needed

12

Starts

2024-07-19

Expected to finish

2027-08-01

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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