← Back to Clinical Trials
Recruiting NCT06430528

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

Trial Parameters

Condition Endogenous Cushing Syndrome
Sponsor University of Michigan
Study Type OBSERVATIONAL
Phase N/A
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-07-19
Completion 2027-05
Interventions
Osilodrostat

Brief 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.

Related Trials