Can a drug tame excess cortisol? new trial tests metyrapone
NCT ID NCT06106295
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tests whether metyrapone, a drug that lowers cortisol production, is safe and effective for people with mild autonomous cortisol secretion (MACS). About 30 participants will take the drug for a period, and researchers will track side effects and cortisol levels. The goal is to see if metyrapone can help manage this hormonal condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metyrapone
- What this could lead to
- If successful, this could point toward a treatment to control cortisol levels in patients with MACS, potentially reducing related health risks.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply broadly. The drug may cause side effects or fail to show clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
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