Using metyrapone to treat mild autonomous cortisol secretion
Metyrapone Intervention in Patients With Mild Autonomous Cortisol Secretion (MACS)
This study is testing if metyrapone can safely help people with Mild Autonomous Cortisol Secretion by lowering their cortisol levels and improving related health issues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06106295 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of metyrapone in treating patients with Mild Autonomous Cortisol Secretion (MACS). Participants will be monitored for changes in blood pressure, blood glucose, blood lipids, and weight while receiving the investigational drug. Metyrapone is known to reduce cortisol production, which may alleviate the symptoms associated with excess cortisol levels. The study is conducted at the Mayo Clinic, which has received approval for this experimental use of the drug in the USA.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with MACS who have abnormal cortisol levels and associated comorbidities such as obesity or hypertension.
Not a fit: Patients without a diagnosis of MACS or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from MACS.
How similar studies have performed: While metyrapone has been used in Europe for ACTH dependent Cushing's Syndrome, its application for MACS in the USA is experimental and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Irina Bancos, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.