Recruiting
Phase 2

Osilodrostat

Sponsor:

Mayo Clinic

Code:

NCT07104812

Conditions

Mild Autonomous Cortisol Secretion

Autonomous Cortisol Secretion (ACS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osilodrostat 1 MG

Study Details

Brief summary:

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

Mild Autonomous Cortisol Secretion

Autonomous Cortisol Secretion (ACS)

Study ID

NCT07104812

Start date

Jan 14, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide written informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age ≥ 18 years
  • Diagnosed with MACS

  • At least 2 abnormal post-dexamethasone cortisol results:

i. 1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL
  • Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment.
  • Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia)
  • At least one of the following comorbidities:

  • Obesity (BMI>30 kg/m2)
  • Dysglycemia
  • Dyslipidemia
  • Hypertension
  • Osteopenia
  • Osteoporosis
  • Fragility fractures
  • Ability to take oral medication and be willing to adhere to the study intervention regimen
  • For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤ 5% per year during the treatment period and for 1 month after the last dose of study treatment.

Exclusion Criteria:

  • Planned alternative therapy for MACS during the study period
  • Current use of oral exogenous glucocorticoid therapy
  • Current use of opioid therapy >20 MME/day
  • Planned use of oral exogenous glucocorticoid therapy
  • Planned use of opioid therapy >20 MME/day
  • Use of injectable glucocorticoid within the last 6 weeks or anticipated glucocorticoid use during the study period.
  • Hypokalemia of hypomagnesemia at baseline visit
  • Prolonged QTc on baseline ECG
  • Concomitant therapy with medications likely to lead to drug-drug interactions (based on PI review).
  • Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome
  • Uncontrolled intercurrent illness including, but not limited to:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnancy or lactation
  • Known allergic reactions to osilodrostat
  • Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone.
  • Treatment with another investigational drug or other intervention within lower than specific therapy washout period

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mild autonomous cortisol secretion (MACS)

Women and men diagnosed with MACS who are patients at Mayo Clinic.

Interventions

Osilodrostat 1 MG

Osilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks

Primary outcome measure

  • Adverse Events [ Time Frame: 4 weeks ]
  • Adrenal insufficiency [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Vanessa Fell, MA

507-266-6068fell.vanessa@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • hypercortisolism
  • cortisol excess
  • Adrenal adenoma
  • Adrenal hyperplasia
  • Cushing Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-11.