NCT07268222

Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Laikο General Hospital, Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS. Primary outcome To compare the efficacy (biochemical and clinical) of the two 11β-hydroxylase inhibitors (CYP11B1), metyrapone and osilodrostat, in patients with MACS not treated surgically (mainly bilateral adenomas or adrenal hyperplasias), as well as their side effects at time 0-, 3- and 6-months post-treatment. Secondary outcome To evaluate alterations in clinical parameters (Blood Pressure, Body Mass Index-BMI), metabolic parameters (fasting blood glucose, insulin, Hb1Ac, HOMA, OGTT and lipids levels) at time 0-, 3- and 6-month after the initiation of the treatment and their effect on Bone Mineral Density (BMD) 1 year post-diagnosis

Conditions

• Mild Autonomous Cortisol Secretion (MACS)

Interventions

Type	Name	Description
DRUG	Metyrapone 250 mg Oral Tablets	metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
DRUG	Osilodrostat 1 MG	administration of 1-3 mg of osilodrostat at 19.00
PROCEDURE	adrenalectomy	Surgery performed in patients with MACS
OTHER	Watch and wait	Follow-up

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-11-01
• Completion: 2027-11-25
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: Greece