Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07104812

Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)

Led by Mayo Clinic · Updated on 2026-02-11

15

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

R

RECORDATI GROUP

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and tolerability of 1 mg osilodrostat therapy in patients with mild autonomous cortisol secretion (MACS), and to determine the impact on 24h urine steroid metabolome and circadian cortisol/cortisone concentrations

CONDITIONS

Official Title

Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Willingness to comply with all study procedures and availability for the study duration
  • Age 18 years or older
  • Diagnosed with mild autonomous cortisol secretion confirmed by at least 2 abnormal post-dexamethasone cortisol results (1 mg cortisol >1.8 mcg/dL or 8 mg cortisol >1 mcg/dL)
  • Historical dexamethasone suppression test results allowed if within 24 months prior to enrollment
  • Adrenal imaging showing benign disease (adrenal adenoma(s), macronodular or micronodular adrenal hyperplasia)
  • Presence of at least one comorbidity: obesity (BMI >30 kg/m2), dysglycemia, dyslipidemia, hypertension, osteopenia, osteoporosis, or fragility fractures
  • Ability and willingness to take oral medication as per study regimen
  • For persons of childbearing potential: agreement to abstain from heterosexual intercourse or use contraceptives with failure rate ≤5% per year during treatment and for 1 month after last dose
Not Eligible

You will not qualify if you...

  • Planned alternative therapy for mild autonomous cortisol secretion during the study
  • Current or planned use of oral exogenous glucocorticoid therapy
  • Current or planned opioid therapy exceeding 20 MME/day
  • Use of injectable glucocorticoids within 6 weeks prior or anticipated during study
  • Hypokalemia or hypomagnesemia at baseline
  • Prolonged QTc on baseline ECG
  • Use of medications likely to cause drug interactions per investigator review
  • Comorbidities or medications affecting hypothalamic-pituitary-adrenal axis or steroid metabolome per investigator judgment
  • Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
  • Pregnancy or lactation
  • Known allergy to osilodrostat
  • Suspected false positive post-dexamethasone cortisol results due to metabolism, absorption issues, or noncompliance
  • Treatment with another investigational drug or intervention within specified washout period

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

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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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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