Actively Recruiting
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
Led by University of Michigan · Updated on 2025-08-20
12
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
R
RECORDATI GROUP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with endogenous Cushing syndrome, either after surgery or if surgery is not an option
- Planned to receive osilodrostat as part of clinical care
- Able to provide informed consent
You will not qualify if you...
- Treated with other investigational drugs within 30 days or five half-lives, whichever is longer
- History of allergic reaction to osilodrostat or similar drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
R
Richard Auchus
CONTACT
T
Thaira Blanco Varela
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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