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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06430528). StuddyBuddy aggregates publicly available trial information.