[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601001":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":45,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":27,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Mild autonomous cortisol secretion (MACS)","EXPERIMENTAL","Women and men diagnosed with MACS who are patients at Mayo Clinic.",[13],"Drug: Osilodrostat 1 MG",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Osilodrostat 1 MG","Osilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Irina Bancos, MD","PRINCIPAL_INVESTIGATOR",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-92.4699,44.02163,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":20,"email":44},"Vanessa Fell, MA","CONTACT","507-266-6068","fell.vanessa@mayo.edu",{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Irina Bancos","Principal Investigator",[49],{"name":50,"class":51},"RECORDATI GROUP","INDUSTRY","100601001","phase-2-impact-of-1-mg-osilodrostat-therapy-on-mild-autonomous-cortisol-secretion-macs-100601001",false,"NCT07104812","Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)","Inclusion Criteria:\n\n* Provide written informed consent\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age ≥ 18 years\n* Diagnosed with MACS\n\n  * At least 2 abnormal post-dexamethasone cortisol results:\n\n    i. 1 mg post-dexamethasone cortisol \\>1.8 mcg\u002FdL or ii. 8 mg post-dexamethasone cortisol \\>1 mcg\u002FdL\n  * Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment.\n* Adrenal imaging phenotype consistent with benign disease (adrenal adenoma\u002Fs, macronodular or micronodular adrenal hyperplasia)\n* At least one of the following comorbidities:\n\n  * Obesity (BMI\\>30 kg\u002Fm2)\n  * Dysglycemia\n  * Dyslipidemia\n  * Hypertension\n  * Osteopenia\n  * Osteoporosis\n  * Fragility fractures\n* Ability to take oral medication and be willing to adhere to the study intervention regimen\n* 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.\n\nExclusion Criteria:\n\n* Planned alternative therapy for MACS during the study period\n* Current use of oral exogenous glucocorticoid therapy\n* Current use of opioid therapy \\>20 MME\u002Fday\n* Planned use of oral exogenous glucocorticoid therapy\n* Planned use of opioid therapy \\>20 MME\u002Fday\n* Use of injectable glucocorticoid within the last 6 weeks or anticipated glucocorticoid use during the study period.\n* Hypokalemia of hypomagnesemia at baseline visit\n* Prolonged QTc on baseline ECG\n* Concomitant therapy with medications likely to lead to drug-drug interactions (based on PI review).\n* Investigator's judgement based on history\u002Fphysical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome\n* 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\n* Pregnancy or lactation\n* Known allergic reactions to osilodrostat\n* Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone.\n* Treatment with another investigational drug or other intervention within lower than specific therapy washout period","ALL","18 Years",{"count":61,"type":62},15,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","The purpose of this study is to evaluate the safety and tolerability of 1 mg osilodrostat therapy in patients with mild autonomous cortisol secretion (MACS), and to determine the impact on 24h urine steroid metabolome and circadian cortisol\u002Fcortisone concentrations",[68,69],"Mild Autonomous Cortisol Secretion","Autonomous Cortisol Secretion (ACS)",[71,72,73,74,75],"hypercortisolism","cortisol excess","Adrenal adenoma","Adrenal hyperplasia","Cushing Syndrome","2026-02-08",{"date":78,"type":79},"2026-02-11","ACTUAL",{"date":81,"type":79},"2026-01-14",{"date":83,"type":62},"2027-01",{"name":5,"class":6},1]