ClinicalTrials.gov record NCT07247058
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Isturisa in Management of Mild Autonomous Cortisol Secretion (MACS)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional study gives the drug Isturisa (osilodrostat) to adults with Mild Autonomous Cortisol Secretion (MACS) and an adrenal adenoma and follows them for up to two years. The study measures blood sugar and lipids, blood pressure, weight, body composition, bone density, carotid thickness, adrenal lesion size, quality of life, and depression symptoms. All participants receive the drug (single-group, open-label) and undergo repeated tests and imaging during follow-up.
What it is studying. The study tests how treatment with osilodrostat (Isturisa) affects metabolic measures (fasting glucose, HbA1c, lipids), blood pressure, weight, body composition, bone mineral density, carotid intima-media thickness, adrenal adenoma size, and patient-reported quality of life and depression scores over time, while also monitoring safety.
What the researchers hope to learn. To characterize the effects of Isturisa on cardiometabolic measures, body composition, bone density, vascular thickness, adrenal lesion size, quality of life, depression symptoms, and to assess the drug's safety profile in people with MACS.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Osilodrostat (Isturisa)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Mild autonomous cortisol secretion (MACS) is diagnosed in up to 48% of patients with incidentally discovered adrenal tumors or hyperplasia. Based on the finding of adrenal masses in 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 low ACTH and DHEAS levels as an indicator of autonomous cortisol secretion. The European Society of Endocrinology-European Network for the Study of Adrenal Tumors (ESE-ENSAT) and the American Association of Clinical Endocrinology (AACE) recommend a cortisol >1.8 μg/dL after 1 mg-DST to define MACS. Several metabolic abnormalities are associated with MACS, including increased cardiovascular disease, mood alteration, hypertension, osteoporosis, hyperglycemia, obesity, weight gain, and lipid abnormalities. Additionally, increased mortality has been reported in MACS patients. Given these complications and increased mortality, there is a need for effective management and treatment options for MACS. This research aims to evaluate the efficacy and safety of Isturisa in patients with MACS to address the current gap in treatment strategies. By assessing how effectively Isturisa improves cardiometabolic disorders and monitoring its safety profile, the research will seek to provide a clearer understanding of its role as a treatment option in MACS patients who are not a surgical candidate or do not want to pursue surgery. This evaluation is crucial for developing more effective treatment options and improving management strategies for MACS, ultimately contributing to better patient management.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive the study drug osilodrostat (Isturisa) and are followed for up to about 2 years. Visits occur approximately every 3 months and include blood tests (for glucose, HbA1c, lipids and other safety labs), weight checks, and questionnaires on quality of life and depression. Imaging and body measurements include DEXA scans for bone density and body composition (baseline, 1 year, 2 years), non-contrast CT to measure adrenal adenoma size (baseline, 1 year, 2 years), and carotid ultrasound at similar imaging time points. Study staff will also monitor for side effects and overall safety during the follow-up visits.
How the study is structured. Interventional, single-group (all participants receive Isturisa), open-label (no masking). Participants start drug treatment and are followed with regular clinic visits and tests—blood tests roughly every 3 months, bone and body composition DEXA scans and imaging at baseline, 1 year and 2 years, and other assessments over a 2-year period.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Mild Autonomous Cortisol Secretion (MACS). Does it apply to my diagnosis?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on congenital adrenal hyperplasia
Important dates
- Study start
- Feb 2, 2026
- Primary completion
- December 2028 (estimated)
- Study completion
- March 2029 (estimated)
- Target enrollment
- 10 participants (estimated)
- Last updated on registry
- Mar 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Johns Hopkins University
- Collaborators
- Recordati Rare Diseases Inc
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Pooneh Jabbaripour Sarmadian, MD 📞 667-208-8367 ✉ pjabbar1@jh.edu
- Tony Keyes 📞 410-550-6259 ✉ akeyes1@jhmi.edu
Participating sites (1)
- Johns Hopkins University School of MedicineRecruiting
Baltimore, Maryland, 21205 · United States
- Amir Hamrahian, MD · 410-955-1578 · ahamrah1@jhmi.edu
- Tony Keyes · akeyes1@jhmi.edu
Terms used on this page · explanations by MedicalUpdates.ai
- Baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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