Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Phase

Condition

Congenital Adrenal Hyperplasia

Vascular Diseases

Circulation Disorders

Treatment

Osilodrostat (Isturisa)

Clinical Study ID

NCT07247058

IRB00511675

Ages > 18
All Genders

Study 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 Criteria

Inclusion

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 laboratoryassessments.

Exclusion

Exclusion Criteria:

Known diagnosis of Cushing's syndrome or overt hypercortisolism.
Current or recent (within 3 months) treatment with glucocorticoids or medicationsaffecting 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, mayinterfere with study participation or safety.

Study Design

Osilodrostat (Isturisa)

February 02, 2026

March 31, 2029

Study Description

Mild autonomous cortisol secretion (MACS) is diagnosed in up to 48% of patients with incidentally discovered adrenal tumors or hyperplasia. Based on the finding of adrenal masses in 5% of adults undergoing cross-sectional imaging, the overall prevalence of MACS is about 1-2%. MACS is characterized by autonomous cortisol secretion without the overt symptoms of Cushing syndrome. It is usually associated with low ACTH and DHEAS levels as an indicator of autonomous cortisol secretion. The European Society of Endocrinology-European Network for the Study of Adrenal Tumors (ESE-ENSAT) and the American Association of Clinical Endocrinology (AACE) recommend a cortisol >1.8 μg/dL after 1 mg-DST to define MACS. Several metabolic abnormalities are associated with MACS, including increased cardiovascular disease, mood alteration, hypertension, osteoporosis, hyperglycemia, obesity, weight gain, and lipid abnormalities. Additionally, increased mortality has been reported in MACS patients. Given these complications and increased mortality, there is a need for effective management and treatment options for MACS.

This research aims to evaluate the efficacy and safety of Isturisa in patients with MACS to address the current gap in treatment strategies. By assessing how effectively Isturisa improves cardiometabolic disorders and monitoring its safety profile, the research will seek to provide a clearer understanding of its role as a treatment option in MACS patients who are not a surgical candidate or do not want to pursue surgery. This evaluation is crucial for developing more effective treatment options and improving management strategies for MACS, ultimately contributing to better patient management.

Connect with a study center

Johns Hopkins University School of Medicine
Baltimore, Maryland 21205
United States
Active - Recruiting
Johns Hopkins University School of Medicine
Baltimore 4347778, Maryland 4361885 21205
United States
Site Not Available

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