Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)

A vizsgálat adatai

Ki végzi

Mayo Clinic

Azonosító

NCT07104812

A regiszteradat frissítve

2026. február 11.

Eredeti leírás

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 concentrationsA teljes eredeti leírásKevesebb

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

Bevonási feltételek: Provide written informed consent; Stated willingness to comply with all study procedures and availability for the duration of the study; Age ≥ 18 years; Diagnosed with MACS; At least 2 abnormal post-dexamethasone cortisol results:; 1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL; Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment; Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia); At least one of the following comorbidities:; Obesity (BMI>30 kg/m2); Dysglycemia; Dyslipidemia; Hypertension; Osteopenia; Osteoporosis; Fragility fractures; Ability to take oral medication and be willing to adhere to the study intervention regimen; 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.

Kizáró feltételek: Planned alternative therapy for MACS during the study period; Current use of oral exogenous glucocorticoid therapy; Current use of opioid therapy >20 MME/day; Planned use of oral exogenous glucocorticoid therapy; Planned use of opioid therapy >20 MME/day; Concomitant therapy with medications likely to lead to drug-drug interactions (based on PI review); Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome; Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone; Treatment with another investigational drug or other intervention within lower than specific therapy washout period; Uncontrolled intercurrent illness including, but not limited to:; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Psychiatric illness/social situations that would limit compliance with study requirements; Known allergic reactions to osilodrostat; Prolonged QTc on baseline ECG; Use of injectable glucocorticoid within the last 6 weeks or anticipated glucocorticoid use during the study period; Hypokalemia of hypomagnesemia at baseline visit; Pregnancy or lactation.

ClinicalTrials.gov NCT07104812