Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
To characterize the impact of Isturisa on clinical features and comorbidities associated with MACS. The investigators hypothesize that patients treated with Isturisa will exhibit significantly better metabolic indicators (such as fasting glucose, HbA1c, and lipid profile), blood pressure, weight, body composition and bone mineral density than at Baseline. The investigators also assess the effect of Isturisa on quality of life and psychological symptoms in patients with MACS. The investigators hypothesize that treatment with Isturisa will lead to significant improvements in quality-of-life scores and reductions in depression scores compared to Baseline.
Eligibility criteria
Qualifiers
Adults aged ≥18 years.
Serum cortisol >1.8 µg/dL after 1 mg overnight dexamethasone suppression test (DST).
Presence of adrenal adenoma confirmed by imaging (CT or MRI).
Ability to provide informed consent.
Disqualifiers
Known diagnosis of Cushing's syndrome or overt hypercortisolism.
Current or recent (within 3 months) treatment with glucocorticoids or medications affecting cortisol production (e.g., ketoconazole, metyrapone).
Severe hepatic impairment or renal failure.
Pregnancy or breastfeeding.
Trial design
Treatments tested in this trial
- Osilodrostat (Isturisa)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
Recordati Rare Diseases Inc
Collaborator
Source ClinicalTrials.gov