Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)

In brief

single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.

Key facts

Study ID

NCT07138274

Run by

Mayo Clinic

People needed

90

Starts

2026-08-01

Expected to finish

2031-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 i. at least 2 abnormal post-dexamethasone cortisol results1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL b. 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.
• Stable timing for bedtime for at least one week prior to on-site study visits.
• History of difficulty providing blood via standard blood draw methods

You may not qualify if…

• Planned alternative therapy for MACS within 12 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 6 weeks prior to Day 1
• 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

Full record on ClinicalTrials.gov

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