[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603573":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":26,"responsibleParty":40,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":26,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metyrapone","EXPERIMENTAL","Subjects in the Metyrapone arm will receive the study drug",[13],"Drug: Metyrapone 250 mg Oral Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subjects in the placebo arm will receive a placebo in lieu of study drug",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metyrapone 250 mg Oral Tablets","Subjects will receive metyrapone beginning at 500 mg and titrating up to 1000 mg",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Subjects will receive placebo at 500 mg dose and titrated up to 1000 mg to match interventional arm and prevent unblinding",[15],[31],{"name":32,"affiliation":5,"role":33},"Irina Bancos, MD, MS","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Vanessa Fell, MA","CONTACT","507-266-6068","fell.vanessa@mayo.edu",{"type":33,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Irina Bancos","Principal Investigator","100603573","phase-2-metyrapone-study-for-patients-diagnosed-with-mild-autonomous-cortisol-secretion---macs-100603573",false,"NCT07138274","Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS","A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Metyrapone in Subjects Diagnosed With Mild Autonomous Cortisol Secretion (MACS)","Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Age ≥ 18 years\n4. Diagnosed with MACS i. at least 2 abnormal post-dexamethasone cortisol results1 mg post-dexamethasone cortisol \\>1.8 mcg\u002FdL or ii. 8 mg post-dexamethasone cortisol \\>1 mcg\u002FdL b. Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment.\n5. Adrenal imaging phenotype consistent with benign disease (adrenal adenoma\u002Fs, macronodular or micronodular adrenal hyperplasia)\n6. At least one of the following comorbidities:\n\n   1. obesity (BMI\\>30 kg\u002Fm2)\n   2. dysglycemia\n   3. dyslipidemia\n   4. hypertension\n   5. osteopenia\n   6. osteoporosis\n   7. fragility fractures\n7. Ability to take oral medication and be willing to adhere to the study intervention regimen.\n8. For persons of childbearing potential: : agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤ 5% per year during the treatment period and for 1 month after the last dose of study treatment.\n9. Stable timing for bedtime for at least one week prior to on-site study visits.\n10. History of difficulty providing blood via standard blood draw methods\n\nExclusion Criteria:\n\n1. Planned alternative therapy for MACS within 12 months after joining the study.\n2. Current use of oral exogenous glucocorticoid therapy\n3. Current use of opioid therapy \\>20 MME\u002Fday\n4. Planned use of oral exogenous glucocorticoid therapy\n5. Planned use of opioid therapy \\>20 MME\u002Fday\n6. Use of injectable glucocorticoid within 6 weeks prior to Day 1\n7. Investigator's judgement based on history\u002Fphysical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome\n8. Uncontrolled intercurrent illness including, but not limited to:\n\n   * Ongoing or active infection\n   * Symptomatic congestive heart failure\n   * Unstable angina pectoris\n   * Cardiac arrhythmia\n   * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n9. Pregnancy or lactation\n10. Known allergic reactions to metyrapone\n11. Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone\n12. Treatment with another investigational drug or other intervention within lower than specific therapy washout period","ALL","18 Years",{"count":53,"type":54},90,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.",[60,61],"Mild Autonomous Cortisol Secretion (MACS)","Autonomous Cortisol Secretion (ACS)",[63,64,65,66,67],"Hypercortisolism","Cortisol excess","Cushing Syndrome","Adrenal adenoma","Adrenal hyperplasia","NOT_YET_RECRUITING","2026-06-25",{"date":71,"type":72},"2026-06-29","ACTUAL",{"date":74,"type":54},"2026-08",{"date":76,"type":54},"2031-12",{"name":5,"class":6}]