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Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)

RecruitingPhase 4Ages 18 Years - anyAllLaikο General Hospital, Athens
NCT07268222 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS. Primary outcome To compare the efficacy (biochemical and clinical) of the two 11β-hydroxylase inhibitors (CYP11B1), metyrapone and osilodrostat, in patients with MACS not treated surgically (mainly bilateral adenomas or adrenal hyperplasias), as well as their side effects at time 0-, 3- and 6-months post-treatment. Secondary outcome To evaluate alterations in clinical parameters (Blood Pressure, Body Mass Index-BMI), metabolic parameters (fasting blood glucose, insulin, Hb1Ac, HOMA, OGTT and lipids levels) at time 0-, 3- and 6-month after the initiation of the treatment and their effect on Bone Mineral Density (BMD) 1 year post-diagnosis

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Metyrapone 250 mg Oral Tablets
  • Osilodrostat 1 MG
  • adrenalectomy
  • Watch and wait
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Where

1 site
Laikon General Hospital
Athens, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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