Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
NCT ID: NCT07268222
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2025-12-01
2027-11-25
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with MACS
Patients with MACS (Adults \> 18 years old with 1mg ODST F levels \>1.8μg/dl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)
Metyrapone 250 mg Oral Tablets
metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
Osilodrostat 1 MG
administration of 1-3 mg of osilodrostat at 19.00
adrenalectomy
Surgery performed in patients with MACS
Watch and wait
Follow-up
Interventions
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Metyrapone 250 mg Oral Tablets
metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
Osilodrostat 1 MG
administration of 1-3 mg of osilodrostat at 19.00
adrenalectomy
Surgery performed in patients with MACS
Watch and wait
Follow-up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Laikο General Hospital, Athens
OTHER
Responsible Party
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Anna Angelousi
associate professor
Locations
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Laikon General Hospital
Athens, , Greece
Countries
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Central Contacts
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Other Identifiers
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Laikon
Identifier Type: -
Identifier Source: org_study_id
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