[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-autonomous-cortisol-secretion-macs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-autonomous-cortisol-secretion-macs":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,72,114,146,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100637013","phase-2-tirzepatide-following-adrenalectomy-in-mild-autonomous-cortisol-secretion-100637013",false,"NCT07573163","Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion","A Randomized Clinical Trial of Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosis of MACS, defined as morning cortisol \\>1.8 mcg\u002FdL after a 1 mg dexamethasone suppression test\n* Elevated blood pressure (SBP ≥120 mmHg or DBP ≥80 mmHg per the 2025 American College of Cardiology\u002FAmerican Heart Association \\[ACC\u002FAHA\\] criteria, or current use of antihypertensive medication)\n* BMI ≥27\n* Undergoing or having undergone adrenalectomy for the treatment of MACS\n\nExclusion Criteria:\n\n* Bilateral adrenal lesions\n* Adrenal malignancy\n* Concurrent primary aldosteronism with MACS\n* Current use of GLP-1 receptor agonists\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Mild Autonomous Cortisol Secretion (MACS) is a condition in which an adrenal gland produces excess cortisol and is associated with high blood pressure, diabetes, and weight gain. Surgical removal of the adrenal gland (adrenalectomy) is standard treatment, but some patients continue to have metabolic health problems after surgery.\n\nThis randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS compared with adrenalectomy alone.",[26,27],"Mild Autonomous Cortisol Secretion (MACS)","Adrenalectomy; Status",[29,30,31],"adrenalectomy","MACS","mild autonomous cortisol secretion","NOT_YET_RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":20},"2026-07",{"date":40,"type":20},"2028-12-31",{"name":42,"class":43},"Alaa Sada","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100603573","phase-2-metyrapone-study-for-patients-diagnosed-with-mild-autonomous-cortisol-secretion---macs-100603573","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",{"count":53,"type":20},90,[23],"single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.",[26,57],"Autonomous Cortisol Secretion (ACS)",[59,60,61,62,63],"Hypercortisolism","Cortisol excess","Cushing Syndrome","Adrenal adenoma","Adrenal hyperplasia","2026-06-25",{"date":33,"type":36},{"date":67,"type":20},"2026-08",{"date":69,"type":20},"2031-12",{"name":71,"class":43},"Mayo Clinic",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":44},"100620765","impact-macs-adrenalectomy-vs-semaglutide-for-metabolic-outcomes-in-mild-autonomous-cortisol-secretion-100620765","NCT07361874","IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion","IMPACT-MACS Study: Investigating the Mechanisms, Pathophysiology, and Cardiometabolic Treatment in Mild Autonomous Cortisol Secretion","IMPACT-MACS","Inclusion Criteria:\n\n* Adults ≥18 years\n* MACS groups: adrenal adenoma + DST cortisol \\>1.8 µg\u002FdL + no overt Cushing + eligible for adrenalectomy\n* Willingness to postpone surgery 6 months if randomized\n* Controls: no adrenal abnormalities + normal DST + BMI ≥27 + ≥2 cardiometabolic conditions\n* Stable medication doses for ≥4 weeks\n* Negative pregnancy test if applicable\n\nExclusion Criteria:\n\n* Prior GLP-1 RA within 90 days\n* Weight change \\>5 kg in past 90 days\n* Prior obesity\u002Fdiabetes surgery\n* Type 1 diabetes or other diabetes types\n* Severe organ disease\n* Recent pancreatitis\n* Pregnancy, breastfeeding\n* Contraindication to semaglutide\n* Contraindication to surgery delay\n* Chronic glucocorticoid use",{"count":81,"type":20},75,[83],"NA","The goal of this study is to learn how two treatments-adrenalectomy (surgical removal of an adrenal gland) and semaglutide (a medication used for weight management)-affect insulin resistance and cortisol regulation in adults with mild autonomous cortisol secretion (MACS). The study will also learn how these treatments impact body composition, blood pressure, cholesterol, inflammation, muscle strength, and quality of life.\n\nThe main questions the study aims to answer are:\n\n1. Does adrenalectomy or semaglutide improve insulin resistance more in people with MACS?\n2. How do these treatments change cortisol patterns and other cardiometabolic risk factors?\n3. Do people with MACS respond differently to semaglutide compared to matched adults without MACS?\n\nParticipants will:\n\n1. Receive either adrenalectomy or semaglutide if they have MACS, or semaglutide if they are matched controls\n2. Complete clinic visits and phone visits over about 26-30 weeks\n3. Undergo metabolic testing such as blood tests, urine steroid profiling, body composition scans, blood pressure monitoring, muscle strength testing, and questionnaires about health and well-being",[26,57,86,87],"Subclinical Cushing's","Mild Autonomous Cortisol Excess",[89,30,90,62,91,59,92,93,94,95,96,97,98,99,100,101,102,103],"Mild Autonomous Cortisol Secretion","Adrenal incidentaloma","Subclinical Cushing","Cortisol dysregulation","Adrenalectomy","Semaglutide","Weight loss","Body composition","Insulin resistance","GLP-1 receptor agonist","Hyperinsulinemic-euglycemic clamp","Cortisol dynamics","Visceral fat","cardiometabolic risk","randomized controlled trial","RECRUITING","2026-03-25",{"date":107,"type":36},"2026-03-27",{"date":109,"type":36},"2026-03-05",{"date":111,"type":20},"2030-05-31",{"name":113,"class":43},"University of Texas Southwestern Medical Center",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":44},"100611936","phase-4-isturisa-treatment-in-mild-autonomous-cortisol-secretion-macs-100611936","NCT07247058","Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)","Isturisa in Management of Mild Autonomous Cortisol Secretion (MACS)","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Diagnosis of mild autonomous cortisol secretion (MACS) defined by:\n* Serum cortisol \\>1.8 µg\u002FdL after 1 mg overnight dexamethasone suppression test (DST).\n* Presence of adrenal adenoma confirmed by imaging (CT or MRI).\n* Ability to provide informed consent.\n* Willingness to undergo study procedures including DEXA scan and laboratory assessments.\n\nExclusion Criteria:\n\n* Known diagnosis of Cushing's syndrome or overt hypercortisolism.\n* Current or recent (within 3 months) treatment with glucocorticoids or medications affecting cortisol production (e.g., ketoconazole, metyrapone).\n* Severe hepatic impairment or renal failure.\n* Pregnancy or breastfeeding.\n* Known allergy or contraindication to osilodrostat (Isturisa).\n* Participation in another interventional clinical trial within the last 30 days.\n* Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or safety.",{"count":122,"type":20},10,[124],"PHASE4","To characterize the impact of Isturisa on clinical features and comorbidities associated with MACS. The investigators hypothesize that patients treated with Isturisa will exhibit significantly better metabolic indicators (such as fasting glucose, HbA1c, and lipid profile), blood pressure, weight, body composition and bone mineral density than at Baseline. The investigators also assess the effect of Isturisa on quality of life and psychological symptoms in patients with MACS. The investigators hypothesize that treatment with Isturisa will lead to significant improvements in quality-of-life scores and reductions in depression scores compared to Baseline.",[26],[30,89,128,129,130,131,132,133,63,134,135,136,137],"Adrenal Adenoma","Osilodrostat","Isturisa","Body Composition","Metabolic Outcomes","Subclinical Cushing Syndrome","Carotid intima thickness","Bone mineral density","Hypertension","Glycemic control","2026-03-03",{"date":109,"type":36},{"date":141,"type":36},"2026-02-02",{"date":143,"type":20},"2029-03",{"name":145,"class":43},"Johns Hopkins University",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":30,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":44},"100542536","detecting-mild-autonomous-cortisol-secretion-in-patients-with-adrenal-incidentaloma-100542536","NCT06344143","Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma","Inclusion Criteria:\n\n1. Patients ages 18 years and older.\n2. Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.\n3. 1-mg Dexamethasone suppression test cortisol ≤ 5 μg\u002FdL with adequate dexamethasone level.\n\nExclusion Criteria:\n\n1. 1-mg Dexamethasone suppression test cortisol \\> 5 μg\u002FdL with adequate dexamethasone level. Patients who fail to suppress below this level will be considered to have Cushing's syndrome and will be referred for appropriate treatment.\n2. Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids).\n3. History of uncontrolled hypertension or history of hypertension with more than 2 medications.\n4. History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c\\>7.5.\n5. Known History of osteoporosis\n6. Documented Clinical Cushing's disease.\n7. Clinical suspicion of adrenal carcinoma.\n8. History of alcohol abuse\u002Fdependence.\n9. History of cirrhosis of liver.\n10. History of hepatitis B or C infection regardless of treatment.\n11. History of type 1 diabetes.\n12. History of hemochromatosis.\n13. History of autoimmune hepatitis.\n14. History of Wilson's disease.",{"count":153,"type":20},20,"OBSERVATIONAL","The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes.",[26],"2026-01-06",{"date":159,"type":36},"2026-01-08",{"date":161,"type":36},"2024-11-20",{"date":163,"type":20},"2030-12-31",{"name":165,"class":43},"The Cleveland Clinic",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":44},"100613563","phase-4-metyrapone-versus-osilodrostat-in-patients-with-metabolic-autonomous-cortisol-secretion-macs-100613563","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)",{"count":174,"type":20},150,[124],"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",[26],[179,180,30,181,182],"cortisol","Cushing","METYRAPONE","osilodrostat","2025-12-03",{"date":185,"type":36},"2025-12-05",{"date":187,"type":36},"2025-12-01",{"date":189,"type":20},"2027-11-25",{"name":191,"class":43},"Laikο General Hospital, Athens"]