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Can a steroid Add-On make cushing syndrome treatment safer?

NCT ID NCT06430528

Disease control Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing a block-and-replace strategy for people with endogenous Cushing syndrome, a condition where the body makes too much cortisol. Participants receive osilodrostat, a drug that lowers cortisol production, along with a replacement glucocorticoid called methylprednisolone. The goal is to see how often adrenal insufficiency occurs during dose adjustment and whether new steroid biomarkers can guide treatment. The study enrolls 12 adults who have had surgery or cannot have surgery and are already considered for osilodrostat.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
osilodrostat combined with a glucocorticoid replacement (methylprednisolone)
What this could lead to
If it works, this approach could give doctors a safer way to control cortisol in people with Cushing syndrome while lowering the chance of a sudden adrenal crisis.
What could go wrong
The study is small, with only 12 participants, so results may not apply to everyone. Adding a steroid could also mask or change how the body responds, and the biomarker findings are exploratory.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients receiving care at the University of Michigan.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency Cushing syndrome endogenous Cushing syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenal insufficiency Endogenous Cushing syndrome Hypercortisolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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