RecruitingNot Applicable

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

United States12 participantsStarted 2024-07-19

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase)

Timeframe: Through phase 1, approximately 24 weeks

Trial details

NCT IDNCT06430528

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05

Contact for this trial

Richard Auchus

734-764-7764 rauchus@med.umich.edu

View on ClinicalTrials.gov More Endogenous Cushing Syndrome trials