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RECRUITING
NCT06430528

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

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

12

Start Date

2024-07-19

Completion Date

2027-08

Last Updated

2025-08-20

Healthy Volunteers

No

Interventions

DRUG

Osilodrostat

Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States