Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaikο General Hospital, Athens
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Abnormal liver enzymes
eGFR < 40 ml/min/1.73 m3
Pseudocushing syndrome
Patients with any malignancy (active or past history), including ACC
Trial design
Design model
Single group
Treatments tested in this trial
Metyrapone 250 mg Oral Tablets
Drugmetyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
Osilodrostat 1 MG
Drugadministration of 1-3 mg of osilodrostat at 19.00
adrenalectomy
Procedure/SurgerySurgery performed in patients with MACS
Watch and wait
Other interventionFollow-up
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients with MACSOther 4 interventions
Trial outcomes
Primary outcomes
1
Comparison of the efficacy of metyrapone and osilodrostat
Blood tests measuring baseline moring cortisol (μg/dl) levels pre and post-treatment
Time frame
Baseline ( at t=0), at t=3 months and at =6 months2
Comparison of the efficacy of metyrapone and osilodristat
Measurement of the baseline morning ACTH (pg/ml) pre and post-treatment
Time frame
Baseline (at t= 0), at t= 3 months and t= 6 months3
Comparison of the efficacy of metyrapone and osilodristat
Measurement of the baseline morning DHEAS levels (μg/dl) pre and post-treatment
Time frame
Baseline ( at t=0), at t=3 months and at t=6 months4
Comparison of the efficacy of metyrapone and osilodristat
Measurement of urinary free cortisol (μg/24h) pre and post-treatment
Time frame
Baseline ( at t=0), at t=3 months and at =6 monthsSecondary outcomes
1
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of fasting blood glucose levels (mg/dl) pre and post-treatment
Time frame
Baseline at t=0 , at 3 months and at 6 months2
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alteration of insuline levels (μU/ml) pre and post-treatment
Time frame
Baseline (t=0), at t=3 months and at t=6 months3
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of Hb1Ac levels (%) pre and post-treatment
Time frame
Baseline (t=0), at t=3 months and at t=6 months4
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of HOMA-IR (glucose levels mmol/l x insuline levels mIU/L/22.5) pre and post -treatment
Time frame
Baseline (t=0) at t=3 months and t=6 monthsOther outcomes
1
Comparison of metyrapone and osilodrostat in terms of other parameters
Alterations of systolic and diastolic blood pressure (mmHg) at morning pre and post-treatment
Time frame
Baseline (t=0), at t=3 months and t=6 months2
Comparison of metyrapone and osilodrostat in terms of other parameters
Alterations of BMI (weight (kg) / height(cm2)) levels pre and post-treatment
Time frame
Baseline (t=0), t=3 months , t=6 months3
Comparison of metyrapone and osilodrostat in terms of other parameters
Alterations of bone mineral density (BMD) in gr /cm3 pre and post-treatment
Time frame
Baseline at t=0 and at t= 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov