Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT07104812
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07104812
Study Brief:
Protocol Section:
NCT07104812