Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

Launched by MAYO CLINIC · Oct 24, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Metyrapone for Mild Autonomous Cortisol Secretion (MACS) study, is looking to see if a medication called metyrapone is safe and effective for people with a condition known as Mild Autonomous Cortisol Secretion (MACS). This condition means that the body produces too much cortisol, a hormone that helps manage stress and metabolism. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with MACS, have certain health conditions like obesity or high blood pressure, and are able to take oral medication regularly.

Participants in the study will need to provide written consent and be willing to follow the study rules for the duration of the trial. They will receive the study medication and will be monitored throughout the process. Important things to note are that women who can become pregnant must use reliable birth control during the study, and certain health conditions or medications may prevent someone from joining. This trial aims to help improve treatment options for individuals with MACS and contribute to our understanding of this condition.

Gender

ALL

Eligibility 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.