RecruitingPhase 4

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

Greece150 participantsStarted 2025-12-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of the efficacy of metyrapone and osilodrostat

Timeframe: Baseline ( at t=0), at t=3 months and at =6 months

Comparison of the efficacy of metyrapone and osilodristat

Timeframe: Baseline (at t= 0), at t= 3 months and t= 6 months

Comparison of the efficacy of metyrapone and osilodristat

Timeframe: Baseline ( at t=0), at t=3 months and at t=6 months

Comparison of the efficacy of metyrapone and osilodristat

Timeframe: Baseline ( at t=0), at t=3 months and at =6 months

Comparison of metyrapone and osilodrostat efficacy

Timeframe: Baseline (at t=0), at t=3 months , at t =6 months

Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters

Timeframe: Baseline (t=0), at t= 3months, at t=6 months

Trial details

NCT IDNCT07268222

SponsorLaikο General Hospital, Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Anna Angelousi, MD, PhD, Msc

00306978167876 a.angelousi@gmail.com

View on ClinicalTrials.gov More Mild Autonomous Cortisol Secretion (MACS) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Comparison of the efficacy of metyrapone and osilodrostat

Timeframe: Baseline ( at t=0), at t=3 months and at =6 months

Comparison of the efficacy of metyrapone and osilodristat

Timeframe: Baseline (at t= 0), at t= 3 months and t= 6 months

Comparison of the efficacy of metyrapone and osilodristat

Timeframe: Baseline ( at t=0), at t=3 months and at t=6 months

Comparison of the efficacy of metyrapone and osilodristat

Timeframe: Baseline ( at t=0), at t=3 months and at =6 months

Comparison of metyrapone and osilodrostat efficacy

Timeframe: Baseline (at t=0), at t=3 months , at t =6 months

Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters

Timeframe: Baseline (t=0), at t= 3months, at t=6 months