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

Recruiting now · Phase 4

Conditions studied: Mild Autonomous Cortisol Secretion (MACS)

In brief

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

Key facts

Study ID

NCT07268222

Run by

Laikο General Hospital, Athens

People needed

150

Starts

2025-12-01

Expected to finish

2027-11-25

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Laikon General Hospital — Athens, Greece (enrolling)

Full record on ClinicalTrials.gov

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