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RecruitingPhase 4

Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Isturisa in Management of Mild Autonomous Cortisol Secretion (MACS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Isturisa in adults with mild autonomous cortisol secretion (MACS), a condition where the adrenal glands make extra cortisol, a stress hormone. It looks at changes in blood sugar, blood fats, blood pressure, weight, body fat and muscle, and bone strength. It also checks quality of life and mood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have MACS, with a blood cortisol level above 1.8 µg/dL after an overnight test using 1 mg of dexamethasone.
  • A CT or MRI scan shows an adrenal adenoma, a non-cancerous growth in an adrenal gland.
  • You can give informed consent, meaning you understand the study and agree to join.
  • You are willing to have study tests, including lab tests and a DEXA scan to measure bone strength and body fat and muscle.

Who can't join

  • You have Cushing's syndrome or clearly high cortisol levels beyond MACS.
  • You take steroid medicines called glucocorticoids or medicines that affect cortisol production, or have taken them in the past 3 months.
  • You have severe liver problems or kidney failure.
  • You are pregnant or breastfeeding.
  • You are allergic to osilodrostat (Isturisa) or have another medical reason you cannot take it.
  • You have taken part in another study testing a treatment or procedure in the past 30 days.
  • The study doctor believes a medical or mental health condition could make joining unsafe or interfere with taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD