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Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

StatusRecruiting
PhasePhase 4
Started2026-02-02
View on ClinicalTrials.gov ↗

Amendment history

2026-03-03
minor
Study Status v3
Start dateestimated 2026-01-20→confirmed 2026-02-02
2026-01-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-06→2028-12
Completion date2028-12→2029-03
Start date2025-12→2026-01-20
Study sitesdetails revised at 1 of 1 site
2025-12-01
minor
Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, References v1
Primary completion date2026-12→2028-06
Secondary endpoints4 entries, revised
Change in adrenal adenoma/hyperplasia size (mm)
Study description-148 characters
Mild autonomous cortisol secretion (MACS) is a conditiondiagnosed in whichup to 48% of patients with incidentally discovered adrenal adenomastumors produceor excesshyperplasia. Based cortisol withouton the clinical featuresfinding of overtadrenal Cushing'smasses syndromein 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 increasedlow risksACTH and DHEAS levels as an indicator of hypertensionautonomous cortisol secreti [...] [...]
Collaborators+27 characters
Recordati Rare Diseases Inc
2025-11-19
minor
Original filing
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.
Trial Details
NCT Number NCT07247058
Lead Sponsor Johns Hopkins University
Collaborators: Recordati Rare Diseases Inc
Conditions Mild Autonomous Cortisol Secretion (MACS)
Enrollment 10 participants
Start Date 2026-02-02
Primary Completion 2028-12 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-05