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Could a Once-Daily pill replace Twice-Daily dosing for adrenal gland recovery?

NCT ID NCT07703098

Disease control Sponsor: University Medical Centre Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study compares two steroid replacement therapies—methylprednisolone and hydrocortisone—in people whose adrenal glands have stopped working properly due to long-term use of high-dose steroids. The goal is to see whether a single morning dose of methylprednisolone is as good as or better than the standard twice-daily hydrocortisone at helping the adrenal glands recover. Participants take one of the two medications for 12 months, and their adrenal function is tested with a short ACTH stimulation test.

What this could mean

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

Active substance
methylprednisolone and hydrocortisone
What this could lead to
If methylprednisolone works as well or better than hydrocortisone, it could offer a simpler, once-daily treatment option for people with adrenal insufficiency caused by steroid use.
What could go wrong
This is a small, early-phase trial with only 66 participants, so results may not apply to everyone. The study compares two existing drugs, so no breakthrough is expected.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 66 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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.

Ages

18 years and older

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: * Age over 18 years. * Suspected adrenal insufficiency due to receiving supraphysiological doses of methylprednisolone for more than 4 weeks. * Receiving methylprednisolone 4 mg for at least the last 4 weeks. * Morning cortisol lower than 300 nmol/L. * Inadequate result of a short ACTH test performed on a physiological dose of methylprednisolone (cortisol rise after 30 min under 470 nmol/L AND after 60 min under 500 nmol/L). * No further indication for treating the underlying disease, and retreatment with glucocorticoids is not expected in the next 2 years. * Consent to participate in the research. Exclusion Criteria: * Known organic disease of the pituitary-adrenal axis. * Body mass over 130 kg. * Advanced comorbidities. * Advanced heart failure (NYHA IV). * Chronic kidney disease IV, eGFR under 30 ml/min. * Liver cirrhosis. * Active malignant disease. * Immune deficiencies. * Planned major surgery during the study duration. * Receiving drugs affecting cortisol metabolism or interfering with cortisol measurements (e.g., systemic estrogens, strong inducers or inhibitors of CYP3A4). * Conditions affecting cortisol metabolism (pregnancy, liver disease, nephrotic syndrome). * Alcohol dependence syndrome (consuming more than 21 units of alcohol per week). * Shift (night) work. * Presence of comorbidities with an expected life expectancy of less than 3 years.

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency secondary adrenal insufficiency

As listed by the trial registrant

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

Adrenal insufficiency

How to take part

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  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

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Contacts and locations

Locations

  • UMC Ljubljana

    Ljubljana, 1000, Slovenia

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