In short
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.
At a glance
- 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
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. It is classified under the ATC code V04CD01, which indicates its use in diagnostic tests related to pituitary function. The medication is produced by HRA PHARMA RARE DISEASES and is authorized for use in certain countries.
Medical Conditions Treated
METYRAPONE BP is being studied for its potential in treating mild autonomous cortisol secretion in patients with adrenal adenoma. 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. 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. The maximum daily dose being studied is 6000 mg, but actual dosing would be determined by a healthcare provider based on individual patient needs. The maximum treatment period under investigation is 12 weeks.
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. 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.
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. 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. 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. 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.