[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613563":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":29,"centralContacts":39,"locations":46,"responsibleParty":59,"collaborators":29,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":29,"enrollmentInfo":72,"targetDuration":29,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Laikο General Hospital, Athens","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with MACS","Patients with MACS (Adults \\> 18 years old with 1mg ODST F levels \\>1.8μg\u002Fdl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)",[12,13,14,15],"Drug: Metyrapone 250 mg Oral Tablets","Drug: Osilodrostat 1 MG","Procedure: adrenalectomy","Other: Watch and wait",[17,25,30,35],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","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",[9],[23,24],"osilodrostat","surgery",{"type":18,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Osilodrostat 1 MG","administration of 1-3 mg of osilodrostat at 19.00",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"PROCEDURE","adrenalectomy","Surgery performed in patients with MACS",[9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Watch and wait","Follow-up",[9],[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Anna Angelousi, MD, PhD, Msc","CONTACT","00306978167876","0030","a.angelousi@gmail.com",[47],{"facility":48,"status":49,"city":50,"state":29,"zip":29,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":29},"Laikon General Hospital","RECRUITING","Athens","Greece","GR",{"type":54,"coordinates":55},"Point",[56,57],23.72784,37.98376,{"lat":57,"lon":56},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Anna Angelousi","associate professor","100613563","phase-4-metyrapone-versus-osilodrostat-in-patients-with-metabolic-autonomous-cortisol-secretion-macs-100613563",false,"NCT07268222","Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)","MOMACS","Inclusion Criteria:\n\n* Adults \\> 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)\n* 1 mg overnight dexamethasone suppression test (ODST): Cortisol levels at 8.00 am\\>1.8 μg\u002Fdl AND i) ACTH\\\u003C 15 pg\u002Fml OR ii) abnormal midnight salivary cortisol OR iii) Urinary free cortisol levels (UFC) \u002F24h ≥ of the UNL\n\nExclusion Criteria:\n\n* Abnormal liver enzymes\n* eGFR \\\u003C 40 ml\u002Fmin\u002F1.73 m3\n* Pseudocushing syndrome\n* Patients with any malignancy (active or past history), including ACC\n* ACTH-dependent Cushing syndrome (Cushing disease or ectopic Cushing syndrome)","ALL","18 Years",{"count":73,"type":74},150,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS.\n\nPrimary 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.\n\nSecondary 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",[80],"Mild Autonomous Cortisol Secretion (MACS)",[82,83,84,85,23],"cortisol","Cushing","MACS","METYRAPONE","2025-12-03",{"date":88,"type":89},"2025-12-05","ACTUAL",{"date":91,"type":89},"2025-12-01",{"date":93,"type":74},"2027-11-25",{"name":5,"class":6},1]