Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
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
| Condition(s) | Mild Autonomous Cortisol Secretion, Autonomous Cortisol Secretion (ACS) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 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: i. 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 medicatio |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mayo Clinic |
| Locations | Rochester, Minnesota, United States |
| Start date | 2026-01-14 |
| NCT ID | NCT07104812 |
| Official listing | https://clinicaltrials.gov/study/NCT07104812 |