Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
Laikο General Hospital, Athens
150 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria2
- Adults \> 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)
- 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 Criteria5
- 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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Interventions
metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
administration of 1-3 mg of osilodrostat at 19.00
Surgery performed in patients with MACS
Follow-up
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07268222