Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
NCT07247058 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-03-05
Summary
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
- Mild Autonomous Cortisol Secretion (MACS)
Interventions
- DRUG
-
Osilodrostat (Isturisa)
The intervention aims to evaluate the impact of osilodrostat on cardiometabolic outcomes, bone mineral density, body composition, adrenal tumor size or hyperplasia, and biochemical markers of cortisol excess.
Sponsors & Collaborators
-
Recordati Rare Diseases Inc
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Amir Hamrahian, MD · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-02
- Primary Completion
- 2028-12-31
- Completion
- 2029-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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