Mild Autonomous Cortisol SecretionPhase 2NCT07104812
Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
A Phase 2 study testing Osilodrostat 1 MG in people with Mild Autonomous Cortisol Secretion and Autonomous Cortisol Secretion (ACS), run by Mayo Clinic at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Autonomous Cortisol Secretion, Autonomous Cortisol Secretion (ACS)
- What is being tested?
- Osilodrostat 1 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL
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- 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 cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Vanessa Fell, MA, 507-266-6068, fell.vanessa@mayo.edu
About this study
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
- Being tested
- Osilodrostat 1 MG
- Keywords
- hypercortisolism, cortisol excess, Adrenal adenoma, Adrenal hyperplasia, Cushing Syndrome
- Medical subject headings
- Cushing Syndrome, ACTH Syndrome, Ectopic, Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osilodrostat 1 MGDrug
Osilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mild autonomous cortisol secretion (MACS) | Experimental | Women and men diagnosed with MACS who are patients at Mayo Clinic. Receives: Drug: Osilodrostat 1 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of adverse events
Measured: 4 weeks
Adrenal insufficiency
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start14 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Autonomous Cortisol SecretionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- RECORDATI GROUP
- Responsible party
- Principal investigator, Irina Bancos, Mayo Clinic
- Investigators
- Irina Bancos, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104812
- Sponsor's protocol ID
- 25-007009
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
- ClinicalTrials.gov ID
- NCT07104812
- Acronym / sponsor ID
- 25-007009
- Keywords
- hypercortisolism, cortisol excess, Adrenal adenoma, Adrenal hyperplasia, Cushing Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- RECORDATI GROUP
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild autonomous cortisol secretion (MACS) | Experimental | Drug: Osilodrostat 1 MGWomen and men diagnosed with MACS who are patients at Mayo Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osilodrostat 1 MGOsilodrostat 1 mg administered between noon and 6 pm daily, for 4 weeks | Drug | Mild autonomous cortisol secretion (MACS) |
Primary outcome
Adverse Events
Time frame: 4 weeks
Number of adverse events
Adrenal insufficiency
Time frame: 4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irina Bancos, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osilodrostat 1 MG in people with Mild Autonomous Cortisol Secretion and Autonomous Cortisol Secretion (ACS), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.