Treatment for adrenal insufficiency in patients with Cushing syndrome using osilodrostat
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
University of Michigan · NCT06430528
This study is testing if the medication osilodrostat, combined with a specific dose of another steroid, can help people with Cushing syndrome avoid adrenal insufficiency while keeping their hormone levels balanced.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06430528 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with endogenous Cushing syndrome who are either post-surgery or not candidates for surgery and are considering osilodrostat as part of their treatment.
Not a fit: Patients currently receiving other investigational drugs or those with hypersensitivity to osilodrostat may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of adrenal insufficiency in patients with Cushing syndrome, leading to better health outcomes.
How similar studies have performed: While this approach is novel in its specific combination of therapies, similar studies have shown promise in managing Cushing syndrome and adrenal insufficiency.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endogenous Cushing Syndrome, Adrenal Insufficiency, Hypercortisolism, Osilodrostat, Glucocorticoid, Methylprednisolone, Medrol