Recruiting

Osilodrostat with Glucocorticoid

Sponsor:

University of Michigan

Code:

NCT06430528

Conditions

Endogenous Cushing Syndrome

Adrenal Insufficiency

Hypercortisolism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Osilodrostat

Study Details

Brief 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

Endogenous Cushing Syndrome

Adrenal Insufficiency

Hypercortisolism

Study ID

NCT06430528

Start date

Jul 19, 2024

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational cohort

Participants with Cushing syndrome consented to participate in block-and-replace osilodrostat therapy.

Interventions

Osilodrostat

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

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 and Locations

Central contacts

Richard Auchus

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

Thaira Blanco Varela

734-647-5661tbv@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Eyad Alsafadi

734-647-5661alsafade@med.umich.edu

Thaira Blanco Varela

734-647-5661tbv@med.umich.edu

Principal Investigator:

Richard Auchus, MD, PhD

More Information

Sponsor

University of Michigan

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Keywords

  • Osilodrostat
  • Glucocorticoid
  • Methylprednisolone
  • Medrol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-08-20.