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:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT06106295
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Diagnosed with MACS: at least 2 abnormal post-dexamethasone cortisol results (1 mg post-dexamethasone cortisol \> 1.8 mcg/d; or 8 mg post-dexamethasone cortisol \> 1 mcg/dL) and 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/m\^2); dysglycemia; dyslipidemia; hypertension; osteopenia; osteoporosis; fragility fractures.
* Ability to take oral medication and be willing to adhere to the study intervention regimen.
* For females of reproductive potential: use of highly effective contraception initiated prior to baseline visit and for 1 month after completing metyrapone study.
* 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 6 months after the last dose of study treatment.
* Stable timing for bedtime for at least one week prior to on-site study visits
Exclusion Criteria:
* Planned alternative therapy for MACS within 6 months after joining the study.
* 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.
* 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 metyrapone.
* 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:
NCT06106295
Study Brief:
Protocol Section:
NCT06106295