Not Yet RecruitingPhase 2

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

90 participantsStarted 2026-04

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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:

What they're measuring

Glucocorticoid to androgen ratio

Timeframe: 3 and 6 months

Delta salivary cortisone

Timeframe: 3 and 6 months

Trial details

NCT IDNCT07138274

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06

Contact for this trial

Vanessa Fell, MA

507-266-6068 fell.vanessa@mayo.edu

View on ClinicalTrials.gov More Mild Autonomous Cortisol Secretion (MACS) trials