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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06430528
Status
Recruiting
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Conditions

  • Adrenal Insufficiency
  • Endogenous Cushing Syndrome
  • Hypercortisolism

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Osilodrostat — DRUG
    Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration.

Study Details

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.

Key Dates

Start date
Jul 19, 2024
Status verified
Aug 2025
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: Observational cohort
    Participants with Cushing syndrome consented to participate in block-and-replace osilodrostat therapy.

Primary Outcome Measure

Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase) [ Time Frame: Through phase 1, approximately 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Eyad Alsafadi
[email protected]
734-647-5661
Thaira Blanco Varela
[email protected]
734-647-5661
Richard Auchus, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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