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RecruitingPhase 4NCT07247058

Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Isturisa in Management of Mild Autonomous Cortisol Secretion (MACS)

Sponsor

Johns Hopkins University

Enrollment

10 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Mild Autonomous Cortisol Secretion (MACS)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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.

Interventions

DRUGOsilodrostat (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.

Locations(1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

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NCT07247058