NCT07268222 Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
| NCT ID | NCT07268222 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Laikο General Hospital, Athens |
| Condition | Mild Autonomous Cortisol Secretion (MACS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2025-12-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07268222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Autonomous Cortisol Secretion (MACS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07268222 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07268222 currently recruiting?
Yes, NCT07268222 is actively recruiting participants. Contact the research team at a.angelousi@gmail.com for enrollment information.
Where is the NCT07268222 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07268222 clinical trial?
NCT07268222 is sponsored by Laikο General Hospital, Athens. The trial plans to enroll 150 participants.