Actively Recruiting
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Led by Johns Hopkins University · Updated on 2026-03-05
10
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
R
Recordati Rare Diseases Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 6518 years
- Diagnosis of mild autonomous cortisol secretion (MACS) with serum cortisol >1.8 bcg/dL after 1 mg overnight dexamethasone suppression test
- Presence of adrenal adenoma confirmed by CT or MRI imaging
- Ability to provide informed consent
- Willingness to undergo study procedures including DEXA scan and laboratory tests
You will not qualify if you...
- Diagnosis of Cushing's syndrome or overt hypercortisolism
- Current or recent (within 3 months) use of glucocorticoids or medications affecting cortisol production (e.g., ketoconazole, metyrapone)
- Severe liver or kidney problems
- Pregnancy or breastfeeding
- Known allergy or contraindication to osilodrostat (Isturisa)
- Participation in another interventional clinical trial within the last 30 days
- Any medical or psychiatric condition that may interfere with study participation or safety according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
P
Pooneh Jabbaripour Sarmadian, MD
CONTACT
T
Tony Keyes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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