Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Recruiting · NCT07247058 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Adults aged ≥18 years.
- Diagnosis of mild autonomous cortisol secretion (MACS) defined by:
- 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.
- Willingness to undergo study procedures including DEXA scan and laboratory assessments.
Exclusion criteria
- 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.
- Known allergy or contraindication to osilodrostat (Isturisa).
- Participation in another interventional clinical trial within the last 30 days.
- Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or safety.
Where it is running
1 location listed across 1 US state.
- Johns Hopkins University School of Medicine - Baltimore, Maryland, United States