Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07247058
Phase
PHASE4
Status
Recruiting
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Conditions

  • Mild Autonomous Cortisol Secretion (MACS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osilodrostat (Isturisa) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Isturisa Treatment Arm
    Participants diagnosed with Mild Autonomous Cortisol Secretion (MACS) will receive Osilodrostat (Isturisa) as an investigational treatment. The intervention aims to evaluate comorbidities associated with MACS after the initiation of osilodrostat(Isturisa).

Primary Outcome Measure

Change in fasting glucose, HbA1c [ Time Frame: Baseline, and then every 3 months up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21205
Amir Hamrahian, MD
[email protected]
410-955-1578
Tony Keyes
[email protected]

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By research site
Johns Hopkins University School of Medicine· Baltimore, MD

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