Mild Autonomous Cortisol Secretion study: Osilodrostat
Official title Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
ClinicalTrials.gov ID: NCT07247058
What this study is testing
What is Osilodrostat (Isturisa)?
an investigational oral medicine being studied as a potential treatment for mild autonomous cortisol secretion (MACS). is designed to block the enzyme 11β‑hydroxylase, reducing cortisol production in the adrenal glands.
Also referred to as Isturisa, LCI699.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to see if Isturisa helps improve blood sugar, blood pressure, weight, bone health, and quality of life in patients with mild cortisol hormone excess.
- Who it's for
- The study is looking for adults diagnosed with Mild Autonomous Cortisol Secretion (MACS).
- What's involved
- Participants will take Isturisa and undergo regular tests to check blood sugar, blood pressure, weight, bone density, and mood.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Having at least two early morning fasting ACTH \<15 pg/mL (last level within 3 months before enrollment)
- 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)...
- 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...
- BMI \>30 kg/m2
You likely can't join if
- Has severe, uncontrolled hypertension (mean SBP \>170 mm Hg or mean Diastolic Blood Pressure (DBP) \>110 mm Hg at Screening)
- 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 severe renal insufficiency (glomerular filtration rate ≤29 mL/min at Baseline).
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- 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...
See the full eligibility criteria
- 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...
- Having at least two early morning fasting ACTH \<15 pg/mL (last level within 3 months before enrollment)
- 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...
- 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
- Has severe, uncontrolled hypertension (mean SBP \>170 mm Hg or mean Diastolic Blood Pressure (DBP) \>110 mm Hg at Screening)
- 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 severe renal insufficiency (glomerular filtration rate ≤29 mL/min at Baseline).
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- 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 (\ 500 ms with wide QRS interval (≥120 ms).
- Has persistent atrial fibrillation.
- Has uncorrected hypokalemia.
- 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...
- Has adrenocortical carcinoma, or the adrenal images are suspicious for an underlying malignancy.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.