Metyrapone versus osilodrostat for metabolic autonomous cortisol secretion (MACS)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare two oral 11β-hydroxylase inhibitors, metyrapone and osilodrostat, in adults with MACS who are managed non-surgically, with follow-up visits at baseline, 3 months, and 6 months to track biochemical and clinical outcomes. The primary outcomes are biochemical cortisol control and clinical side effects at 0, 3, and 6 months, while secondary outcomes include blood pressure, BMI, fasting glucose/insulin measures, lipids, and a one-year bone mineral density assessment. Eligible participants must meet biochemical criteria on overnight dexamethasone suppression testing and have adrenal adenomas or hyperplasia on imaging; key exclusions include abnormal liver tests, eGFR <40, ACTH-dependent Cushing, and active or prior malignancy. Treatments include oral metyrapone or osilodrostat, with surgical adrenalectomy or observational management considered when appropriate, and all visits occur at Laikon General Hospital in Athens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults \> 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)
* 1 mg overnight dexamethasone suppression test (ODST): Cortisol levels at 8.00 am\>1.8 μg/dl AND i) ACTH\< 15 pg/ml OR ii) abnormal midnight salivary cortisol OR iii) Urinary free cortisol levels (UFC) /24h ≥ of the UNL

Exclusion Criteria:

* Abnormal liver enzymes
* eGFR \< 40 ml/min/1.73 m3
* Pseudocushing syndrome
* Patients with any malignancy (active or past history), including ACC
* ACTH-dependent Cushing syndrome (Cushing disease or ectopic Cushing syndrome)

Where it's running

• Laikon General Hospital
  Athens, Greece Recruiting

Study contacts

• Study coordinator: Anna Angelousi, MD, PhD, Msc
• Email: a.angelousi@gmail.com
• Phone: 00306978167876

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tirzepatide after adrenalectomy for MACS

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• Isturisa treatment for people with mild autonomous cortisol secretion (MACS)

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• Metyrapone for Mild Autonomous Cortisol Secretion

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• Detecting cortisol secretion issues in patients with adrenal incidentalomas

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  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT06344143

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.