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NCT06430528
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
Conditions: Endogenous Cushing Syndrome, Adrenal Insufficiency, Hypercortisolism
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 12
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06430528). StuddyBuddy aggregates publicly available trial information.