Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07247058

Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Led by Johns Hopkins University · Updated on 2026-03-05

10

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

R

Recordati Rare Diseases Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 6518 years
  • Diagnosis of mild autonomous cortisol secretion (MACS) with serum cortisol >1.8 bcg/dL after 1 mg overnight dexamethasone suppression test
  • Presence of adrenal adenoma confirmed by CT or MRI imaging
  • Ability to provide informed consent
  • Willingness to undergo study procedures including DEXA scan and laboratory tests
Not Eligible

You will not qualify if you...

  • Diagnosis of Cushing's syndrome or overt hypercortisolism
  • Current or recent (within 3 months) use of glucocorticoids or medications affecting cortisol production (e.g., ketoconazole, metyrapone)
  • Severe liver or kidney problems
  • 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 may interfere with study participation or safety according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21205

Actively Recruiting

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Research Team

P

Pooneh Jabbaripour Sarmadian, MD

CONTACT

T

Tony Keyes

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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