Isturisa treatment for people with mild autonomous cortisol secretion (MACS)
Isturisa in Management of Mild Autonomous Cortisol Secretion (MACS)
This trial will test whether Isturisa (osilodrostat) helps adults with MACS improve metabolic measures, blood pressure, weight, bone density, and quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07247058 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study gives adults with imaging-confirmed adrenal adenomas and MACS oral osilodrostat (Isturisa) and compares metabolic, cardiovascular, body composition, bone density, and quality-of-life measures to baseline. Participants undergo regular laboratory testing, DEXA scans, blood pressure and weight monitoring, and psychological and quality-of-life assessments over the treatment period. Safety and adverse events are recorded throughout to characterize the drug's tolerability in this population. The trial focuses on non-surgical MACS patients to define a medical treatment option for cortisol excess without overt Cushing syndrome.
Who should consider this trial
Good fit: Adults aged 18 or older with MACS defined by serum cortisol >1.8 µg/dL after a 1 mg dexamethasone suppression test and an adrenal adenoma on CT or MRI who can consent and complete study procedures are ideal candidates.
Not a fit: Patients with overt Cushing syndrome, recent glucocorticoid or cortisol‑modifying therapy, severe liver or kidney failure, pregnancy or breastfeeding, or known allergy to osilodrostat are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, Isturisa could lower excess cortisol and improve cardiometabolic risk factors, blood pressure, body composition, bone density, and quality of life for patients with MACS.
How similar studies have performed: Osilodrostat has proven effective at lowering cortisol in Cushing disease, but its use specifically for MACS is relatively novel and has limited prior trial data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amir Hamrahian, MD — Johns Hopkins University
- Study coordinator: Pooneh Jabbaripour Sarmadian, MD
- Email: pjabbar1@jh.edu
- Phone: 667-208-8367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.