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Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

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…

ClinicalTrials.gov IDNCT07247058

PhasePHASE4

Enrollment10

SponsorJohns Hopkins University

Age18 Years

SexALL

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Conditions studied

Mild Autonomous Cortisol Secretion (MACS)

About this study

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.

Primary outcomes

Change in fasting glucose, HbA1c (Baseline, and then every 3 months up to 2 years)
Change in bone mineral density (g/cm²) (Baseline, 1 year, and 2 years)
Change in body weight (kg) from baseline during Isturisa treatment (Baseline and every 3 months up to 2 years)
Change in lipid profile from baseline during Isturisa treatment (Baseline and every 3 months up to 2 years)
Change in body composition (kg) (baseline, 1 year and 2 years)

Eligibility information

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.

Study locations

Johns Hopkins University School of Medicine, Baltimore, Maryland 21205 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.