RecruitingPhase 2NCT07104812
Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
Sponsor
Mayo Clinic
Enrollment
15 participants
Start Date
Jan 14, 2026
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria18
- 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 Criteria20
- 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 anticipated glucocorticoid use during the study period.
- Hypokalemia of hypomagnesemia at baseline visit
- Prolonged QTc on baseline ECG
- 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
- 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
- Pregnancy or lactation
- Known allergic reactions to osilodrostat
- 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
Interventions
DRUGOsilodrostat 1 MG
Osilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07104812