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

NCT06430528 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Osilodrostat

Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration.

Sponsors & Collaborators

Principal Investigators

  • Richard Auchus, MD, PhD · University of Michigan

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2027-05-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430528 on ClinicalTrials.gov