Treatment for adrenal insufficiency in patients with Cushing syndrome using osilodrostat

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome who are treated with osilodrostat alongside glucocorticoid replacement therapy. Participants will receive osilodrostat and a physiologic dose of methylprednisolone, with close monitoring and adjustments to medication based on cortisol levels. The study will also evaluate new biomarker steroids to ensure proper dosing and assess the safety and clinical outcomes of the treatment approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Richard Auchus, MD, PhD — University of Michigan
• Study coordinator: Richard Auchus
• Email: rauchus@med.umich.edu
• Phone: 734-764-7764

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.