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Study of Osilodrostat for Mild Autonomous Cortisol Secretion (MACS)

This study is testing a medication called osilodrostat (1 mg) in people with Mild Autonomous Cortisol Secretion (MACS), a condition where your body makes too much cortisol (a hormone). The main goals are to see if osilodrostat is safe and well-tolerated, and to understand how it affects your body's hormone levels. You might be able to join if you are 18 or older and have been diagnosed with MACS, specifically with at least two abnormal post-dexamethasone cortisol results. The study aims to enroll 15 participants. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved
Participants will take 1 mg of osilodrostat daily between noon and 6 pm for 4 weeks. You will need to comply with all study procedures and be available for the study's duration.
Compensation
Not stated in the trial record.
Follow-up
Safety and adrenal insufficiency will be measured at 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07104812

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~15 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Osilodrostat 1 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over 4 weeks
+1 more outcome measured

Conditions

Mild Autonomous Cortisol Secretion
Autonomous Cortisol Secretion (ACS)

Explore related trials

Adrenal Cortical AdenomaAdrenal HyperplasiaMild Autonomous Cortisol Secretion

NCT07104812

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Irina Bancos, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Vanessa Fell, MA
[email protected]
507-266-6068
Email the study team

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Adverse Events4 weeks

    Number of adverse events

  • Adrenal insufficiency4 weeks

    Number of subjects to experience adrenal insufficiency, defined as combined measurements of cortisol \< 7 mcg/dL and ACTH\>60 pg/dL or single cortisol \< 5 mcg/dL