Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to evaluate the safety and tolerability of 1 mg osilodrostat therapy in patients with mild autonomous cortisol secretion (MACS), and to determine the impact on 24h urine steroid metabolome and circadian cortisol/cortisone concentrations
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide written informed consent
Stated willingness to comply with all study procedures and availability for the duration of the study
Age ≥ 18 years
Diagnosed with MACS
Disqualifiers
Planned alternative therapy for MACS during the study period
Current use of oral exogenous glucocorticoid therapy
Current use of opioid therapy >20 MME/day
Planned use of oral exogenous glucocorticoid therapy
Trial design
Design model
Single group
Treatments tested in this trial
Osilodrostat 1 MG
DrugOsilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Mild autonomous cortisol secretion (MACS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
Number of adverse events
Time frame
4 weeks2
Adrenal insufficiency
Number of subjects to experience adrenal insufficiency, defined as combined measurements of cortisol \< 7 mcg/dL and ACTH\>60 pg/dL or single cortisol \< 5 mcg/dL
Time frame
4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
RECORDATI GROUP
Collaborator
Source ClinicalTrials.gov