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Effects of metyrapone and hydrocortisone on cardio‑metabolic health and circadian rhythm in patients with mild autonomous cortisol secretion

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have mild autonomous cortisol secretion, a condition where the adrenal glands release a small amount of cortisol, a hormone that helps control stress and metabolism, even when it is not needed. The medication being tested is called metyrapone, which works by lowering the amount of cortisol the body makes. All participants will also receive a standard dose of hydrocortisone to keep basic hormone levels stable, and some will receive a placebo, which looks the same but contains no active drug.

The purpose of the study is to find out whether taking the study drug in the evening can improve heart‑related and metabolism measures and help reset the body’s internal clock. Participants are randomly assigned to receive either the active medication or the placebo for several weeks, then after a short break they switch to the other option, without knowing which they are taking. During the study, they will have regular visits for simple tests such as blood draws, a scan that checks the amount of fat in the liver (hepatic lipid content), blood pressure checks while lying down, and basic blood counts that show inflammation. Terms like “cardio‑metabolic” refer to the heart and metabolism together, while “chronobiology” means the daily rhythm that controls many body functions.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After joining the study, you will be randomly assigned to one of two sequences: receiving the active medication first followed by placebo, or receiving placebo first followed by the active medication. the assignment is double‑blinded, meaning neither you nor the study staff will know which medication you are taking at any time.

  2. Step 2

    Baseline assessments

    Before any medication is taken, a series of measurements will be performed. these include a scan to determine hepatic (liver) lipid content, blood tests to evaluate insulin sensitivity and inflammation, and blood pressure recordings taken while you are lying down. the results provide a reference point for later comparison.

  3. Step 3

    First treatment period

    During this phase you will take the study medication each evening.

    If you are assigned to the active medication, you will receive Metycor 250 mg soft capsules. the total daily dose is 6000 mg, which is taken as the appropriate number of capsules once in the evening. the capsules are swallowed whole with water.

    If you are assigned to placebo, you will receive capsules that look identical but contain no active drug; the dosing schedule is the same as for the active medication.

    Throughout both treatment periods you will also continue your usual background therapy with Hydrocortisone 10 mg tablets. the prescribed total dose is 30 mg per day, taken orally as three tablets. this background medication is not altered by the study.

  4. Step 4

    Monitoring during first period

    Regular visits will be scheduled to check your safety and to record blood pressure and any side effects. additional blood samples may be taken to monitor liver fat, insulin measures, and inflammatory markers.

  5. Step 5

    Washout period

    After the first treatment phase, a washout period will occur during which you will stop taking the study medication. this break allows the effects of the first medication to wear off before you start the next phase.

  6. Step 6

    Second treatment period

    You will now receive the medication that you did not receive in the first period.

    The dosing schedule is identical to the first period: an evening dose of either Metycor 250 mg soft capsules (total 6000 mg) or matching placebo capsules, plus continued background Hydrocortisone 10 mg tablets (30 mg daily).

  7. Step 7

    Monitoring during second period

    The same safety visits and measurements performed during the first period will be repeated. blood pressure, blood tests, and liver imaging will be collected to compare the effects of the two treatments.

  8. Step 8

    Final assessments and study completion

    At the end of the second treatment phase, the final set of measurements will be taken, mirroring the baseline assessments. after these assessments, your participation in the study will be concluded.

Who can join the trial?

3 criteria

  • Be a man or a woman between 18 and 80 years old.
  • Have a blood level of cortisol higher than 1.8 µg/dL after a 1 mg dexamethasone suppression test, a simple test that checks how the body controls cortisol.
  • Have an adrenal adenoma, which is a small, non‑cancerous growth on the adrenal gland that makes cortisol.

Who cannot join the trial?

8 criteria

  • Having any signs of Cushing’s syndrome, such as a red face (facial plethora), a “buffalo hump” of fat on the upper back (dorsocervical fat pad), purple stretch marks (purple striae), easy bruising, or loss of muscle near the center of the body (proximal muscular atrophy).
  • Showing any imaging results that look like they might be cancer (radiological signs suspect of malignancy).
  • Having an adrenal gland tumor that makes excess adrenaline (pheochromocytoma) or a condition that causes the adrenal gland to release too much aldosterone, leading to high blood pressure (primary hyperaldosteronism).
  • Currently taking diabetes medicines such as insulin or pills called sulfonylureas.
  • Having used steroid medicines (called glucocorticoids) within the three months before the study starts.
  • Having serious, long‑lasting kidney problems (advanced chronic kidney disease) or serious liver problems (advanced chronic liver disease).
  • Taking other medicines that strongly affect the liver enzyme CYP3A4, which can change how the study drug works.
  • Taking medicines that are known to change the level of the hormone cortisol in the blood (serum cortisol), such as estrogen‑based birth control pills.
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Investigated drugs

  • Metyrapone

    is the medication being tested in this study. It is taken by mouth and works by lowering the amount of cortisol that the body makes. In this trial, participants will take metyrapone in the evening to see if it can improve heart‑related health measures, such as blood pressure and cholesterol, and also to see whether it can help reset the body’s internal clock in people who have a mild, ongoing excess of cortisol.

  • Hydrocortisone

    is a medication that is given to all participants as part of their regular background treatment. It is a form of the hormone cortisol that the body normally produces. In the study, hydrocortisone is used to keep the normal hormone balance stable while the researchers look at the effects of the test drug, metyrapone.

What is already known about the treatment

  • Metyrapone

    It is taken by mouth as a soft capsule, usually in the evening. The drug is approved in many countries for diagnostic testing of adrenal function and is also used off‑label to treat excess cortisol production, so it appears in medical literature as both a test and a therapy. Metyrapone belongs to the class of adrenal steroidogenesis inhibitors and works by blocking the enzyme 11‑beta‑hydroxylase, which stops the final step of cortisol synthesis. By lowering cortisol levels it helps to study and manage mild autonomous cortisol secretion.

  • Hydrocortisone

    This medication is taken orally as a tablet. It is an established, widely approved glucocorticoid that is used for hormone replacement in adrenal insufficiency and for its anti‑inflammatory effects, and it is well described in clinical references. Hydrocortisone belongs to the glucocorticoid class and works by binding to glucocorticoid receptors, mimicking the natural hormone cortisol and reducing inflammation. In the trial it serves as background therapy for patients with mild autonomous cortisol secretion.

Investigated diseases

Mild autonomous cortisol secretion (MACS) - Mild autonomous cortisol secretion (MACS) is a condition where the adrenal gland produces slightly higher amounts of cortisol without the classic signs of Cushing syndrome. It is often discovered incidentally during imaging for other reasons. The excess cortisol tends to increase slowly over time, leading to subtle changes in metabolism and blood pressure. As the hormone levels rise, patients may develop higher blood sugar, increased fat in the liver, and mild alterations in blood vessel function. The condition can remain stable for years or slowly progress, sometimes evolving into overt Cushing syndrome.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526837-24-00Protocol codeCHRONCOMACSEstimated enrolment40 patientsSponsorMedical University Of Vienna

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