Recruiting PHASE4 Mild Autonomous Cortisol Secretion (MACS)

New treatment option for Mild Autonomous Cortisol Secretion (MACS)

Official title Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

ClinicalTrials.gov ID: NCT07247058

What this study is testing

What is Osilodrostat (Isturisa)?

Osilodrostat (Isturisa) is an investigational medicine, being studied as a potential treatment for mild autonomous cortisol secretion (macs).

Also referred to as Osilodrostat, Isturisa.

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
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.
  • 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

  • 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.

You likely can't join if

  • 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 treatment clinical trial within the last 30 days.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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 treatment 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Baltimore, Maryland, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

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 - 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?

Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.