NCT07138274 · Mayo Clinic
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
What this study is about
single-center, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment Phase 2 study to evaluate safety and effectiveness of overnight metyrapone in patients with MACS.
View original scientific description
single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.
Interventions
DRUG
Metyrapone 250 mg Oral Tablets
Subjects will receive metyrapone beginning at 500 mg and titrating up to 1000 mg
DRUG
Placebo
Subjects will receive placebo at 500 mg dose and titrated up to 1000 mg to match interventional arm and prevent unblinding
Primary outcome measures
Glucocorticoid to androgen ratio
Time frame: 3 and 6 months
Glucocorticoid to androgen ratio will be calculated based on total glucocorticoids and total androgens measured through 25-steroid urine profiling.
Delta salivary cortisone
Time frame: 3 and 6 months
Waking salivary cortisone and bedtime salivary cortisone will be assessed, and delta calculated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
- 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 criteria
- 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
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations