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

Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) (NCT07104812) is a Phase 2 interventional studying Mild Autonomous Cortisol Secretion and Autonomous Cortisol Secretion (ACS), sponsored by Mayo Clinic. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Mild Autonomous Cortisol Secretion and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 15 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Provide written willing to sign a consent form - 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. Who Should NOT Join This Trial: - 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Osilodrostat 1 MG

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Mayo Clinic

Rochester, Minnesota, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07104812), the sponsor (Mayo Clinic), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07104812 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07104812?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07104812?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07104812. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07104812. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.