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
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