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

Launched by UNIVERSITY OF MICHIGAN · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with endogenous Cushing syndrome, a condition where the body produces too much cortisol, which can lead to various health issues. The trial is testing a medication called osilodrostat, which helps block the production of excess cortisol, while also providing glucocorticoid replacement therapy to support adrenal function. The main goal is to see how often adrenal insufficiency occurs in patients taking osilodrostat and to evaluate the safety and effectiveness of this combined treatment.

To participate in this study, individuals must have been diagnosed with endogenous Cushing syndrome and may have either undergone surgery or are not candidates for surgery. They should be considering osilodrostat as part of their treatment plan and be able to give their consent to join the study. Participants can expect to be closely monitored for their health and any changes related to the treatment. It's important to note that those who have recently participated in other clinical trials or have had allergic reactions to osilodrostat will not be eligible for this study. This trial is currently recruiting patients of all genders, aged between 18 and 75 years.

Gender

ALL

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.

Trial Officials