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Drug metyrapone shows promise for Cushing's patients who Can't have surgery

NCT ID NCT05255900

Disease control Sponsor: Istituto Auxologico Italiano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug metyrapone in 20 people with mild Cushing's syndrome who were not candidates for surgery. Over 24 weeks, researchers measured changes in blood pressure, blood sugar, cholesterol, bone health, and mental health. The goal was to see if metyrapone could help control these problems caused by high cortisol levels.

What this could mean

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

Active substance
metyrapone
What this could lead to
If successful, metyrapone could become a treatment option for patients with mild Cushing's syndrome who cannot have surgery, helping control blood pressure and blood sugar.
What could go wrong
This is a small, completed study with only 20 participants, so results may not apply to everyone. Metyrapone can cause side effects like nausea or low blood pressure.

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

20 people

The number who actually took part.

Started

Apr 2022

Finished

Dec 2025

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 with hypercortisolism referred to the outpatient clinic who were already on metirapone therapy.

Ages

18 to 85 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: * Patients with mild Cushing's Syndrome not candidate for surgery * Current therapy with metyrapone since less than 1 week * Cortisol levels at 08:00 after 1 mg-overnight dexamethasone suppression test (1mgDST) \>1.8 μg/dL * Confirmed with 2 mg two days dexamethasone suppression test (2mgx2dDST) * Presence of at least one out of the following conditions: type 2 diabetes mellitus, impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), arterial hypertension, bone mineral density (BMD) Z-score \< -2.0 and/or fragility fracture at any skeletal site * Stable anti-hypertensive therapies and blood pressure (BP) levels in the month before enrolment * Stable anti-diabetic therapies and glycometabolic control during the month before enrolment * Stable body weight during the month before enrolment Exclusion Criteria: * Signs and/or symptoms of overt hypercortisolism (striae rubrae, moon facies, easy bruising, buffalo hump, hypertrichosis) * Malignant hypertension and/or BP \<200/120 mmHg * Severe hyperglycemia (i.e. FG \>350 mg/dL) * Urinary free cortisol (UFC) higher than 1.5 fold the upper normal range * Presence of pheochromocytoma or primary hyperaldosteronism * Possible adrenal metastases or radiological features suggestive for adrenal malignancy (i.e. not homogeneous pattern, necrosis, calcifications, irregular margins, local invasion and high density at computed tomography) * Congenital adrenal hyperplasia * Intake of drugs influencing cortisol metabolism and/or secretion * Women in child-bearing age * Patients with body mass index (BMI) \>35 kg/m2

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Conditions

The condition(s) this trial relates to.

Cushing syndrome

As listed by the trial registrant

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

Hypercortisolism

Contacts and locations

Locations

  • Istituto Auxologico Italiano

    Milan, 20149, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.