Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06430528 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot specified
Started2024-07-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later May 2027 → Oct 2027
See other at-risk trials from University of Michigan

Amendment history

2026-09-03
Study Status, Contacts/Locations v3
Primary completion pushed: 2027-05 → 2027-10
Completion pushed: 2027-08 → 2028-01
2025-08-14
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2024-08-07
Study Status, Outcome Measures, Contacts/Locations v1
Start dateestimated 2024-05→confirmed 2024-07-19
Secondary endpoints11 entries, revised
AdrenalRate insufficiencyof adrenal insufficient episodes duringper Phasepatient 2per (maintenance)year ChangeMean change in HgbA1c for participant with HgbA1c > 6.4% at entry.
Study sitescontacts updated at 1 of 1 site
2024-05-23
Original filing
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.
Trial Details
NCT Number NCT06430528
Lead Sponsor University of Michigan
Collaborators: RECORDATI GROUP
Conditions Endogenous Cushing Syndrome, Adrenal Insufficiency, Hypercortisolism
Enrollment 12 participants
Start Date 2024-07-19
Primary Completion 2027-10 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-09