ClinicalTrials.gov record NCT07104812

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 study gives adults with mild autonomous cortisol secretion (MACS) a daily 1 mg dose of osilodrostat for four weeks and monitors safety. The study also measures changes in 24-hour urine steroid metabolites and daytime/nighttime cortisol and cortisone levels. There is a single open treatment group; outcomes are collected over the 4-week treatment period.

What it is studying. The study is testing the safety and tolerability of a once-daily 1 mg oral dose of osilodrostat in adults with MACS, and whether this dose changes the 24-hour urine steroid metabolome and circadian (day–night) cortisol and cortisone concentrations.

What the researchers hope to learn. Scientific goals: to evaluate safety and tolerability of 1 mg osilodrostat in MACS and to characterize its effects on 24-hour urine steroid metabolites and circadian cortisol/cortisone concentrations.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Osilodrostat 1 MG

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take osilodrostat 1 mg orally once daily between noon and 6 pm for 4 weeks. Provide 24‑hour urine collections and timed cortisol/cortisone measurements; have safety assessments including blood tests (e.g., potassium, magnesium, cortisol, ACTH), ECG for QTc, and regular side‑effect/adverse-event monitoring. Study staff will record adverse events and monitor for adrenal insufficiency during treatment. People of childbearing potential must agree to the contraception/abstinence requirement during treatment and for 1 month after the last dose.

How the study is structured. Phase 2 interventional (treatment) study with a single open-label group. All participants receive oral osilodrostat 1 mg once daily (taken between noon and 6 pm) for four weeks. The study is not masked and monitors participants for adverse events and measures hormone and urine steroid changes during the 4-week period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Mild Autonomous Cortisol Secretion; Autonomous Cortisol Secretion (ACS). Does it apply to my diagnosis?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital adrenal hyperplasia

Clinical trials43 trials listed for congenital adrenal hyperplasiaEvery trial the registry lists for congenital adrenal hyperplasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital adrenal hyperplasia researchLatest monthly update: September 2026. Includes: Bedtime hydrocortisone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 14, 2026
Primary completion
January 2027 (estimated)
Study completion
January 2027 (estimated)
Target enrollment
15 participants (estimated)
Last updated on registry
Feb 11, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Mayo Clinic
Principal investigator
Irina Bancos, Principal Investigator
Mayo Clinic
Collaborators
  • RECORDATI GROUP

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
glucocorticoid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
QTc
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Concomitant therapy
Other medicines a participant takes during the study. Some must be reported; some are restricted.
investigational drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
washout period
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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