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NCT07138274From ClinicalTrials.govRecruiting

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

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Metyrapone in Subjects Diagnosed With Mild Autonomous Cortisol Secretion (MACS)

  • Mild Autonomous Cortisol Secretion (MACS)
  • Autonomous Cortisol Secretion (ACS)

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Mayo Clinic
Enrolment target
90
Started
October 2026
Main results due
June 2031
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Provide written informed consent.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age ≥ 18 years
4. 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.
5. Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia)
6. At least one of the following comorbidities:

   1. obesity (BMI\>30 kg/m2)
   2. dysglycemia
   3. dyslipidemia
   4. hypertension
   5. osteopenia
   6. osteoporosis
   7. fragility fractures
7. Ability to take oral medication and be willing to adhere to the study intervention regimen.
8. 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.
9. Stable timing for bedtime for at least one week prior to on-site study visits.
10. History of difficulty providing blood via standard blood draw methods

Exclusion Criteria:

1. Planned alternative therapy for MACS within 12 months after joining the study.
2. Current use of oral exogenous glucocorticoid therapy
3. Current use of opioid therapy \>20 MME/day
4. Planned use of oral exogenous glucocorticoid therapy
5. Planned use of opioid therapy \>20 MME/day
6. Use of injectable glucocorticoid within 6 weeks prior to Day 1
7. Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome
8. 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
9. Pregnancy or lactation
10. Known allergic reactions to metyrapone
11. Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone
12. Treatment with another investigational drug or other intervention within lower than specific therapy washout period

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(1)

  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07138274. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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