Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) (NCT07104812) | Clinical Trial Compass
RecruitingPhase 2
Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
United States15 participantsStarted 2026-01-14
Plain-language 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
Age range18 Years
SexALL
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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 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.
Exclusion Criteria:
* 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
* Use of injectable glucocorticoid within the last 6 weeks or anti…