Recruiting

Isturisa

Sponsor:

Johns Hopkins University

Code:

NCT07247058

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osilodrostat (Isturisa)

Study Details

Brief 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.

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Study ID

NCT07247058

Start date

Feb 2, 2026

Status verified date

Mar, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Isturisa Treatment Arm

Participants diagnosed with Mild Autonomous Cortisol Secretion (MACS) will receive Osilodrostat (Isturisa) as an investigational treatment. The intervention aims to evaluate comorbidities associated with MACS after the initiation of osilodrostat(Isturisa).

Interventions

Osilodrostat (Isturisa)

The intervention aims to evaluate the impact of osilodrostat on cardiometabolic outcomes, bone mineral density, body composition, adrenal tumor size or hyperplasia, and biochemical markers of cortisol excess.

Primary outcome measure

  • Change in fasting glucose, HbA1c [ Time Frame: Baseline, and then every 3 months up to 2 years ]
  • Change in bone mineral density (g/cm²) [ Time Frame: Baseline, 1 year, and 2 years ]
  • Change in body weight (kg) from baseline during Isturisa treatment [ Time Frame: Baseline and every 3 months up to 2 years ]
  • Change in lipid profile from baseline during Isturisa treatment [ Time Frame: Baseline and every 3 months up to 2 years ]
  • Change in body composition (kg) [ Time Frame: baseline, 1 year and 2 years ]

Central Contacts and Locations

Central contacts

Pooneh Jabbaripour Sarmadian, MD

667-208-8367pjabbar1@jh.edu

Tony Keyes

410-550-6259akeyes1@jhmi.edu

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Amir Hamrahian, MD

410-955-1578ahamrah1@jhmi.edu

Tony Keyes

akeyes1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • MACS
  • Mild Autonomous Cortisol Secretion
  • Adrenal Adenoma
  • Osilodrostat
  • Isturisa
  • Body Composition
  • Metabolic Outcomes
  • Subclinical Cushing Syndrome
  • Adrenal hyperplasia
  • Carotid intima thickness
  • Bone mineral density
  • Hypertension
  • Glycemic control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-05.