NCT07247058 Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
| NCT ID | NCT07247058 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Johns Hopkins University |
| Condition | Mild Autonomous Cortisol Secretion (MACS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 10 participants in total. It began in 2026-02-02 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Amir Hamrahian, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07247058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Autonomous Cortisol Secretion (MACS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07247058 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07247058 currently recruiting?
Yes, NCT07247058 is actively recruiting participants. Contact the research team at pjabbar1@jh.edu for enrollment information.
Where is the NCT07247058 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07247058 clinical trial?
NCT07247058 is sponsored by Johns Hopkins University. The principal investigator is Amir Hamrahian, MD at Johns Hopkins University. The trial plans to enroll 10 participants.