NCT07138274

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a double blind, placebo-controlled phase II trial of the safety and efficacy of Metyrapone, in the treatment of MACS. Subjects will be remotely screened and interested qualified subjects will be remotely consented. Subjects will be randomized 2:1 for 6 months of the main study. At 6 months, two options will be available for subjects for months 6-12: open-label arm, observational arm.

Conditions

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

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-06-01
• Completion: 2031-12-01
• First posted: 2025-08-22
• Last updated: 2025-08-22

Regulatory

• FDA-regulated drug study