Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

• Status: Recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out whether the study drug, metyrapone, is safe and effective in treating participants with Mild Autonomous Cortisol Secretion (MACS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Metyrapone

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.