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Recruiting NCT07104812

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

Phase II Interventional Mild Autonomous Cortisol Secretion Autonomous Cortisol Secretion (ACS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Osilodrostat 1 MG.
Who it may be relevant to
Registry conditions: Mild Autonomous Cortisol Secretion, Autonomous Cortisol Secretion (ACS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT07104812 · 25-007009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗