NCT07247058RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Isturisa in Management of Mild Autonomous Cortisol Secretion (MACS)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 2 Feb 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- High blood pressure
- NCT number
- NCT07247058
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 10
- From 2 Feb 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has used or plans to use any treatments for MACS within 12 weeks before Screening and throughout the study, including metyrapone, mifepristone, ketoconazole, fluconazole, or any investigational drug for the treatment of hypercortisolism.
Other illness
- Has severe, uncontrolled hypertension (mean SBP \>170 mm Hg or mean Diastolic Blood Pressure (DBP) \>110 mm Hg at Screening)
- Has severe renal insufficiency (glomerular filtration rate ≤29 mL/min at Baseline).
- Has adrenocortical carcinoma, or the adrenal images are suspicious for an underlying malignancy.
Lab values
- Has poorly controlled DM (HbA1c \>11% at Screening).
- Has abnormal liver test results (total bilirubin \>1.5×ULN or elevated alanine aminotransferase or aspartate aminotransferase \>3×ULN at Baseline).
- Has prolonged QT interval corrected for heart rate using Fridericia's equation (QTcF) (\>450 ms for men and \>470 ms for women) with a normal QRS interval (\<120 ms) or QTcF interval \>500 ms with wide QRS interval (≥120 ms).
Age
- Female patients of childbearing potential who cannot use a highly effective method of contraception, including all women \<50 years old, women whose surgical sterilization was performed \<6 months ago.
Other
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Has persistent atrial fibrillation.
- Has uncorrected hypokalemia.
- Has autonomous co-secretion of aldosterone.
- Has plans for adrenalectomy or nodulectomy during the study.
- Pregnancy, lactating, or intends to become pregnant in the next 2 years.
Criteria the registry did not label
- Age \>18 years old with confirmed mild autonomous cortisol secretion (MACS) Cushing's syndrome, defined by:
- At least two abnormal 1 mg Dexamethasone suppression tests (Cortisol \> 1.8 ug/dL at 8-9 am after taking 1 mg dexamethasone at 11 pm) with appropriate dexamethasone level for the assay (last level within 3 months before enrollment).
- Having at least two early morning fasting ACTH \<15 pg/mL (last level within 3 months before enrollment)
- Presence of at least one of the following comorbidities:
- The presence of prediabetes or Type 2 diabetes mellitus (T2DM): fasting plasma glucose ≥100 mg/dL and/or 2-hour Oral Glucose Tolerance Test (OGTT) glucose ≥140 mg/dL, or HbA1c ≥5.7%
- Systolic hypertension is defined as a mean Systolic Blood Pressure (SBP) ≥130 mmHg after 5 min rest in a seated position (mean of 3 blood pressure measurements 5 minutes apart) irrespective of the number of anti-hypertensive medications.
- BMI \>30 kg/m2
- The presence of an adrenal adenoma or hyperplasia, as determined by CT or MRI studies
- Negative urine pregnancy test at Baseline (urine) for women of childbearing potential
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.