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Recruiting NCT07268222

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

Phase IV Interventional Mild Autonomous Cortisol Secretion (MACS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metyrapone 250 mg Oral Tablets, Osilodrostat 1 MG, adrenalectomy, Watch and wait.
Who it may be relevant to
Registry conditions: Mild Autonomous Cortisol Secretion (MACS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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

Primary outcome measures

  • Comparison of the efficacy of metyrapone and osilodrostat [Time frame: Baseline ( at t=0), at t=3 months and at =6 months]
  • Comparison of the efficacy of metyrapone and osilodristat [Time frame: Baseline (at t= 0), at t= 3 months and t= 6 months]
  • Comparison of the efficacy of metyrapone and osilodristat [Time frame: Baseline ( at t=0), at t=3 months and at t=6 months]
  • Comparison of the efficacy of metyrapone and osilodristat [Time frame: Baseline ( at t=0), at t=3 months and at =6 months]
  • Comparison of metyrapone and osilodrostat efficacy [Time frame: Baseline (at t=0), at t=3 months , at t =6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0), at t= 3months, at t=6 months]
Secondary outcome measures (8)
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline at t=0 , at 3 months and at 6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0), at t=3 months and at t=6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0), at t=3 months and at t=6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0) at t=3 months and t=6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0), at t=3 months and at t=6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0), at t=3 months and at t=6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline (t=0), at t=3 months and at t=6 months]
  • Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Time frame: Baseline at t=0, at t=3 months , at t=6 months]

Eligibility criteria

Inclusion criteria

  • Adults > 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)
  • 1 mg overnight dexamethasone suppression test (ODST): Cortisol levels at 8.00 am>1.8 μg/dl AND i) ACTH< 15 pg/ml OR ii) abnormal midnight salivary cortisol OR iii) Urinary free cortisol levels (UFC) /24h ≥ of the UNL

Exclusion criteria

  • Abnormal liver enzymes
  • eGFR < 40 ml/min/1.73 m3
  • Pseudocushing syndrome
  • Patients with any malignancy (active or past history), including ACC
  • ACTH-dependent Cushing syndrome (Cushing disease or ectopic Cushing syndrome)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Greece · 1 center
  • Laikon General Hospital — Athens

Identifiers

NCT: NCT07268222 · Laikon

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗