Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT07104812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D000182', 'term': 'ACTH Syndrome, Ectopic'}, {'id': 'D000312', 'term': 'Adrenal Hyperplasia, Congenital'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009384', 'term': 'Paraneoplastic Endocrine Syndromes'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D047808', 'term': 'Adrenogenital Syndrome'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D043202', 'term': 'Steroid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553306', 'term': 'Osilodrostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '4 weeks', 'description': 'Number of adverse events'}, {'measure': 'Adrenal insufficiency', 'timeFrame': '4 weeks', 'description': 'Number of subjects to experience adrenal insufficiency, defined as combined measurements of cortisol \\< 7 mcg/dL and ACTH\\>60 pg/dL or single cortisol \\< 5 mcg/dL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypercortisolism', 'cortisol excess', 'Adrenal adenoma', 'Adrenal hyperplasia', 'Cushing Syndrome'], 'conditions': ['Mild Autonomous Cortisol Secretion', 'Autonomous Cortisol Secretion (ACS)']}, 'descriptionModule': {'briefSummary': '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/cortisone concentrations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/dL or ii. 8 mg post-dexamethasone cortisol \\>1 mcg/dL\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/s, macronodular or micronodular adrenal hyperplasia)\n* At least one of the following comorbidities:\n\n * Obesity (BMI\\>30 kg/m2)\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/day\n* Planned use of oral exogenous glucocorticoid therapy\n* Planned use of opioid therapy \\>20 MME/day\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/physical 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/social 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"}, 'identificationModule': {'nctId': 'NCT07104812', 'briefTitle': 'Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)', 'orgStudyIdInfo': {'id': '25-007009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild autonomous cortisol secretion (MACS)', 'description': 'Women and men diagnosed with MACS who are patients at Mayo Clinic.', 'interventionNames': ['Drug: Osilodrostat 1 MG']}], 'interventions': [{'name': 'Osilodrostat 1 MG', 'type': 'DRUG', 'description': 'Osilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks', 'armGroupLabels': ['Mild autonomous cortisol secretion (MACS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Irina Bancos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'RECORDATI GROUP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Irina Bancos', 'investigatorAffiliation': 'Mayo Clinic'}}}}