Clinical trial · Interventional
Metyrapone for Mild Autonomous Cortisol Secretion (MACS)
Metyrapone Intervention in Patients With Mild Autonomous Cortisol Secretion (MACS)
NCT06106295CI-TRIAL-00095585active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out whether the study drug, metyrapone, is safe and effective in treating participants with Mild Autonomous Cortisol Secretion (MACS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autonomous Cortisol Secretion | — | UNRESOLVED | — |
| Mild Autonomous Cortisol Secretion (MACS) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metyrapone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mild Autonomous Cortisol Secretion (MACS) Open Label Phase and Optional Extension Phase
- description
- Subjects diagnosed with Mild Autonomous Cortisol Secretion (MACS) will receive metyrapone for a 6 month treatment period (Open Label Phase) with the option to continue for an additional 30 months of metyrapone therapy. If a patient chooses to participate in the Optional Extension Phase they will continue to receive metyrapone therapy until Month 36. This is an additional 30 months of therapy after completion of the Open Label Phase.
- interventionNames
- Drug: Metyrapone
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 50 months
- description
- Number of participants to experience adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provide written informed consent. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Diagnosed with MACS: at least 2 abnormal post-dexamethasone cortisol results (1 mg post-dexamethasone cortisol \> 1.8 mcg/d; or 8 mg post-dexamethasone cortisol \> 1 mcg/dL) and 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/m\^2); dysglycemia; dyslipidemia; hypertension; osteopenia; osteoporosis; fragility fractures. * Ability to take oral medication and be willing to adhere to the study intervention regimen. * For females of reproductive potential: use of highly effective contraception initiated prior to baseline visit and for 1 month after completing metyrapone study. * 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 6 months after the last dose of study treatment. * Stable timing for bedtime for at least one week prior to on-site study visits Exclusion Criteria: * Planned alternative therapy for MACS within 6 months after joining the study. * 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. * 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 metyrapone. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.