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Osilodrostat and Glucocorticoid Replacement for Cushing Syndrome

This observational study is looking at people with endogenous Cushing syndrome (a condition where your body makes too much cortisol). It's testing a treatment approach called "block-and-replace" using osilodrostat (a medication) along with methylprednisolone (a steroid replacement). The main goal is to see how many participants experience adrenal insufficiency (when your adrenal glands don't make enough hormones) during the first phase of treatment, which lasts about 24 weeks. You might be able to join if you are 18-75 years old, have Cushing syndrome, are considering osilodrostat as part of your care, and can give informed consent. The study is currently unclear on its recruitment status and plans to enroll 12 participants.

Study design
This is an observational study with an unclear status, planning to enroll 12 participants. It is not specified if it is randomized, blinded, or what phase it is in.
What's involved
You would take osilodrostat and methylprednisolone daily. You would have frequent communication with study staff, at least twice weekly for the first 3 months and weekly until your osilodrostat dose is stable. Blood and urine samples would be collected every 4-12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured through Phase 1, which is approximately 24 weeks.

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NCT06430528

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

Recruiting
Not specifiedAges 18–75Observational
University of Michigan
~12 participants
Updated 2025-08-20 on ClinicalTrials.gov
What's tested:Osilodrostat

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase)
Measured over Through phase 1, approximately 24 weeks

Conditions

Endogenous Cushing Syndrome
Adrenal Insufficiency
Hypercortisolism

Explore related trials

Cushing Syndrome

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Richard Auchus, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Richard Auchus
[email protected]
734-764-7764
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase)Through phase 1, approximately 24 weeks

    based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy