NCT06106295

Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

Metyrapone Intervention in Patients With Mild Autonomous Cortisol Secretion (MACS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether the study drug, metyrapone, is safe and effective in treating participants with Mild Autonomous Cortisol Secretion (MACS).

Detailed description

This study will look at how well metyrapone controls blood pressure, blood glucose, blood lipids and weight. Metyrapone is approved in the United States of America (USA) by the Federal Drug Administration (FDA) for use in the diagnosis of adrenal insufficiency. It is not approved in the USA for the treatment of MACS. It is approved in Europe for the treatment of ACTH dependent Cushing's Syndrome. Metyrapone is currently being tested to evaluate the safety (side effects/risks) and efficacy (benefits), so its use for the treatment of MACS is experimental in the USA. Its effectiveness is unproven in the USA and metyrapone is considered an investigational study drug in the USA. The Mayo Clinic IRB has given approval for this drug to be used in this setting. Patients diagnosed with MACS have abnormal cortisol levels above the normal range. Cortisol acts by binding with the cortisol receptors in many tissues of the body. Metyrapone works by reducing cortisol production, thereby decreasing the effects of too much cortisol. Metyrapone doesn't affect levels of other hormones in your body.

Conditions

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

Interventions

Type	Name	Description
DRUG	Metyrapone	250 to 1000 milligram (mg) orally in one or two doses in the evening (administered 4 and 2 hours prior to bed)

Timeline

• Start date: 2023-12-19
• Primary completion: 2028-01-31
• Completion: 2028-02-01
• First posted: 2023-10-30
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study