Status:
NOT_YET_RECRUITING
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
Lead Sponsor:
Mayo Clinic
Conditions:
Mild Autonomous Cortisol Secretion (MACS)
Autonomous Cortisol Secretion (ACS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.
Detailed Description
This study is a double blind, placebo-controlled phase II trial of the safety and efficacy of Metyrapone, in the treatment of MACS. Subjects will be remotely screened and interested qualified subjects...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07138274
Start Date
April 1 2026
End Date
December 1 2031
Last Update
August 22 2025
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