Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
United States10 participantsStarted 2026-02-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fasting glucose, HbA1c
Timeframe: Baseline, and then every 3 months up to 2 years
2
Change in bone mineral density (g/cm²)
Timeframe: Baseline, 1 year, and 2 years
3
Change in body weight (kg) from baseline during Isturisa treatment
Timeframe: Baseline and every 3 months up to 2 years
4
Change in lipid profile from baseline during Isturisa treatment
Timeframe: Baseline and every 3 months up to 2 years