Actively Recruiting
Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
Led by Laikο General Hospital, Athens · Updated on 2025-12-05
150
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia confirmed by imaging
- Cortisol levels greater than 1.8 bcg/dl at 8:00 am after a 1 mg overnight dexamethasone suppression test
- One of the following: ACTH below 15 pg/ml, abnormal midnight salivary cortisol, or urinary free cortisol levels above the upper normal limit in 24 hours
You will not qualify if you...
- Abnormal liver enzymes
- Kidney function (eGFR) less than 40 ml/min/1.73 m2
- Pseudocushing syndrome
- Any history of malignancy, including adrenocortical carcinoma
- ACTH-dependent Cushing syndrome, including Cushing disease or ectopic Cushing syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Laikon General Hospital
Athens, Greece
Actively Recruiting
Research Team
A
Anna Angelousi, MD, PhD, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here