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Could a drug tame excess cortisol in a common hormone disorder?

NCT ID NCT07138274

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether the drug metyrapone can safely lower cortisol levels in people with mild autonomous cortisol secretion (MACS), a condition where the adrenal glands produce too much cortisol. Participants will receive either metyrapone or a placebo for a short period, and researchers will measure changes in hormone ratios and daily cortisol patterns. The goal is to see if metyrapone can help control the hormone imbalance and improve health outcomes.

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, metyrapone could offer a way to manage cortisol levels in people with MACS, potentially reducing related health risks.
What could go wrong
This is an early Phase 2 study with only 90 participants, so results may not apply broadly. Metyrapone can cause side effects like nausea or dizziness.

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 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide written informed consent. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age ≥ 18 years 4. Diagnosed with MACS i. at least 2 abnormal post-dexamethasone cortisol results1 mg post-dexamethasone cortisol \>1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol \>1 mcg/dL b. Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment. 5. Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia) 6. At least one of the following comorbidities: 1. obesity (BMI\>30 kg/m2) 2. dysglycemia 3. dyslipidemia 4. hypertension 5. osteopenia 6. osteoporosis 7. fragility fractures 7. Ability to take oral medication and be willing to adhere to the study intervention regimen. 8. 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. 9. Stable timing for bedtime for at least one week prior to on-site study visits. 10. History of difficulty providing blood via standard blood draw methods Exclusion Criteria: 1. Planned alternative therapy for MACS within 12 months after joining the study. 2. Current use of oral exogenous glucocorticoid therapy 3. Current use of opioid therapy \>20 MME/day 4. Planned use of oral exogenous glucocorticoid therapy 5. Planned use of opioid therapy \>20 MME/day 6. Use of injectable glucocorticoid within 6 weeks prior to Day 1 7. Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome 8. 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 9. Pregnancy or lactation 10. Known allergic reactions to metyrapone 11. Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone 12. 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.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.