NCT07104812 Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
| NCT ID | NCT07104812 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Mild Autonomous Cortisol Secretion |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2026-01-14 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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
Contact & Investigator
Irina Bancos, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07104812 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Autonomous Cortisol Secretion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07104812 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07104812 currently recruiting?
Yes, NCT07104812 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT07104812 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07104812 clinical trial?
NCT07104812 is sponsored by Mayo Clinic. The principal investigator is Irina Bancos, MD at Mayo Clinic. The trial plans to enroll 15 participants.