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Metyrapone Bp

A clinical trial is currently underway to study the effects of Metyrapone BP, a medication used to treat certain hormonal conditions. This trial focuses on patients with mild autonomous cortisol secretion due to adrenal adenoma, a condition where the adrenal glands produce too much cortisol hormone. The study aims to investigate how Metyrapone BP impacts cardiometabolic risk factors and changes in the body’s natural rhythms (chronobiology) in these patients. This research could provide valuable insights into managing this condition and improving patient outcomes.

Table of Contents

What is METYRAPONE BP?

METYRAPONE BP is an active substance used in a medication called Metyrapone HRA, which comes in the form of 250mg soft capsules[1]. It is classified under the ATC code V04CD01, which indicates its use in diagnostic tests related to pituitary function[1]. The medication is produced by HRA PHARMA RARE DISEASES and is authorized for use in certain countries[1].

Medical Conditions Treated

METYRAPONE BP is being studied for its potential in treating mild autonomous cortisol secretion in patients with adrenal adenoma[1]. This condition occurs when a benign tumor (adenoma) on the adrenal gland produces excess cortisol without the typical signs of Cushing’s syndrome. It’s important to note that this use is currently under investigation and may not be an approved indication yet.

How METYRAPONE BP Works

METYRAPONE BP works by affecting the hypothalamus-pituitary-adrenal (HPA) axis, which is responsible for regulating cortisol production in the body[1]. It inhibits an enzyme involved in cortisol synthesis, potentially helping to reduce excess cortisol levels in patients with autonomous cortisol secretion.

Administration and Dosage

Metyrapone HRA is administered orally in the form of soft capsules[1]. The maximum daily dose being studied is 6000 mg, but actual dosing would be determined by a healthcare provider based on individual patient needs[1]. The maximum treatment period under investigation is 12 weeks[1].

Current Clinical Trial

A clinical trial (number 2024-512100-19-00) is currently investigating the use of METYRAPONE BP in patients with mild autonomous cortisol secretion due to adrenal adenoma[1]. This study aims to better understand the effects of this condition on cardiometabolic risk factors and chronobiology patterns.

Eligibility Criteria

The study includes specific criteria for participation:

Inclusion Criteria:

  • Age over 18 years
  • History of an adrenal adenoma
  • Morning cortisol levels greater than 1.8 μg/dl following a 1 mg dexamethasone suppression test
  • No classical clinical features associated with Cushing’s syndrome

Exclusion Criteria:

  • HbA1c greater than 8% or insulin therapy
  • Uncontrolled hypertension
  • Recent glucocorticoid treatment
  • Concomitant medications affecting HPA signaling or CYP3A4 metabolism
  • Suspected malignant adrenal tumors
  • Severe chronic kidney or liver disease
  • Pregnancy or breastfeeding
  • MRI contraindications

These criteria ensure that the study focuses on the specific patient group that may benefit from the treatment while minimizing potential risks[1].

Study Objectives

The main objective of the clinical trial is to perform cardiometabolic phenotyping of patients with autonomous cortisol secretion and identify a disease-specific chronobiology profile in patients with altered HPA axis signaling[1]. This means the researchers are looking at how this condition affects heart and metabolic health, as well as the body’s natural rhythms.

A secondary objective is to investigate how treatment with metyrapone impacts cardiometabolic risk factors in these patients[1]. This could provide valuable information on the potential benefits of the medication for this specific condition.

Study Endpoints

The primary endpoint of the study is the measurement of hepatic lipid content (HCL) using a special type of MRI called 1H magnetic resonance spectroscopy[1]. This will help researchers understand how the condition and treatment affect fat accumulation in the liver.

Secondary endpoints include:

  • Insulin secretion and sensitivity
  • Body composition and fat distribution
  • Heart function and fat accumulation around the heart
  • Fat deposition in muscles and heart muscle
  • Blood pressure measurements
  • Markers of systemic inflammation

These endpoints will provide a comprehensive picture of how autonomous cortisol secretion affects various aspects of health and how treatment with metyrapone might improve these factors[1].

Aspect Details
Study Drug Metyrapone BP (Metyrapone HRA 250mg soft capsules)
Main Objective Investigate cardiometabolic risk factors and chronobiology changes in patients with autonomous adrenal cortisol secretion
Secondary Objective Assess the impact of metyrapone treatment on cardiometabolic risk factors
Primary Endpoint Hepatic lipid content measured by magnetic resonance spectroscopy
Key Inclusion Criteria Age > 18 years, history of adrenal adenoma, specific cortisol levels after dexamethasone suppression test
Key Exclusion Criteria Uncontrolled diabetes or hypertension, recent glucocorticoid treatment, certain kidney or liver diseases, pregnancy or breastfeeding
Maximum Daily Dose 6000 mg
Maximum Treatment Period 12 months

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to study the cardiometabolic characteristics of patients with autonomous cortisol secretion and identify specific changes in their body's natural rhythms, particularly in relation to the hypothalamus-pituitary-adrenal (HPA) axis signaling.
  • Who can participate in this clinical trial? Participants must be over 18 years old with a history of adrenal adenoma. For the autonomous cortisol secretion group, they must have a morning cortisol level higher than 1.8 ug/dl after a dexamethasone suppression test. For the control group, the morning cortisol level should be 1.8 ug/dl or lower after the same test.
  • What is Metyrapone BP and how is it used in this trial? Metyrapone BP is the active substance in Metyrapone HRA 250mg soft capsules. In this trial, it's being investigated for its impact on cardiometabolic risk factors in patients with autonomous adrenal cortisol secretion.
  • What are the main things the researchers will measure? The primary focus is on measuring hepatic lipid content using magnetic resonance spectroscopy. They will also assess insulin secretion and sensitivity, body composition, heart function, fat distribution, blood pressure, and markers of inflammation.
  • Are there any specific exclusion criteria for this trial? Yes, participants will be excluded if they have uncontrolled diabetes (HbA1c > 8%), uncontrolled hypertension, recent glucocorticoid treatment, certain kidney or liver diseases, pregnancy, or breastfeeding. There are also restrictions related to MRI compatibility.

Ongoing Clinical Trials on Metyrapone Bp

  • Study on Metyrapone for Patients with Mild Autonomous Cortisol Secretion Due to Adrenal Adenoma

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria

Glossary

  • Adrenal adenoma: A non-cancerous tumor that develops in the adrenal gland, which can sometimes lead to excessive hormone production.
  • Autonomous cortisol secretion: A condition where the adrenal glands produce too much cortisol hormone without responding to the body's normal regulatory signals.
  • Cardiometabolic risk factors: Factors that increase the risk of heart disease, stroke, and diabetes, such as high blood pressure, abnormal cholesterol levels, and insulin resistance.
  • Chronobiology: The study of biological rhythms and cycles in living organisms, including sleep-wake cycles and hormone production patterns.
  • Dexamethasone suppression test: A test used to assess the function of the adrenal glands by measuring how cortisol levels respond to a dose of dexamethasone, a synthetic glucocorticoid.
  • Hypothalamus-pituitary-adrenal (HPA) axis: A complex set of interactions between the hypothalamus, pituitary gland, and adrenal glands that regulates many body processes, including stress response and cortisol production.
  • Metyrapone: A medication that blocks the production of cortisol in the adrenal glands, used to diagnose or treat certain hormonal disorders.
  • Magnetic resonance spectroscopy: A non-invasive imaging technique that can measure the chemical composition of tissues, used in this study to assess liver fat content.

References

  1. http://clinicaltrials.eu/trial/study-on-metyrapone-for-patients-with-mild-autonomous-cortisol-secretion-due-to-adrenal-adenoma/