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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07138274
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metyrapone 250 mg Oral Tablets — DRUG
    Subjects will receive metyrapone beginning at 500 mg and titrating up to 1000 mg
  • Placebo — DRUG
    Subjects will receive placebo at 500 mg dose and titrated up to 1000 mg to match interventional arm and prevent unblinding

Study Details

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

Key Dates

First listed
Aug 22, 2025
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metyrapone
    Subjects in the Metyrapone arm will receive the study drug
  • Placebo Comparator: Placebo
    Subjects in the placebo arm will receive a placebo in lieu of study drug

Primary Outcome Measure

Glucocorticoid to androgen ratio [ Time Frame: 3 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Vanessa Fell, MA
[email protected]
507-266-6068
Irina Bancos, MD, MS (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic· Rochester, MN

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