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New treatment option for Mild Autonomous Cortisol Secretion
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?
Osilodrostat 1 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for mild autonomous cortisol secretion.
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
- 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
- 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. 8 mg post-dexamethasone cortisol \>1...
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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.