RecruitingPhase 4

Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

United States10 participantsStarted 2026-02-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in fasting glucose, HbA1c

Timeframe: Baseline, and then every 3 months up to 2 years

Change in bone mineral density (g/cm²)

Timeframe: Baseline, 1 year, and 2 years

Change in body weight (kg) from baseline during Isturisa treatment

Timeframe: Baseline and every 3 months up to 2 years

Change in lipid profile from baseline during Isturisa treatment

Timeframe: Baseline and every 3 months up to 2 years

Change in body composition (kg)

Timeframe: baseline, 1 year and 2 years

Trial details

NCT IDNCT07247058

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Pooneh Jabbaripour Sarmadian, MD

667-208-8367 pjabbar1@jh.edu

View on ClinicalTrials.gov More Mild Autonomous Cortisol Secretion (MACS) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in fasting glucose, HbA1c

Timeframe: Baseline, and then every 3 months up to 2 years

Change in bone mineral density (g/cm²)

Timeframe: Baseline, 1 year, and 2 years

Change in body weight (kg) from baseline during Isturisa treatment

Timeframe: Baseline and every 3 months up to 2 years

Change in lipid profile from baseline during Isturisa treatment

Timeframe: Baseline and every 3 months up to 2 years

Change in body composition (kg)

Timeframe: baseline, 1 year and 2 years