Mild Autonomous Cortisol Secretion study: Osilodrostat
Official title Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
ClinicalTrials.gov ID: NCT07104812
What this study is testing
What is Osilodrostat 1 MG?
This is an investigational pill being studied to see if it helps manage mild autonomous cortisol secretion. It is designed to block an enzyme in the body that helps make cortisol, a stress hormone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if the drug is safe and easy to take. It also looks at how it changes hormone levels in the body.
- Who it's for
- People who have a condition where their body makes a little too much cortisol on its own.
- What's involved
- Participants will take a 1 mg pill of osilodrostat. They will provide urine samples and blood tests to check hormone levels.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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)
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.