Effects of Metyrapone in Patients With Hypercortisolism

NCT05255900 | Completed

• 1 other identifier: 05J102
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the present study are to evaluate in patients with mild hypercortisolism the effect of metyrapone treatment on glycometabolic control, blood pressure, thrombotic risk parameters, lipid profile, bone turnover markers, mental health and cortisol circadian rhythm.

Conditions

Hypercortisolism

Keywords

cortisol; metyrapone; hypercortisolism; mild hypercortisolism

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a mean systolic BP reduction of ≥5 mm Hg

  BP levels will be measured with arterial blood pressure monitoring (ABPM)

  Baseline, 24 weeks

Secondary Outcomes (6)

• Changes in glycometabolic control

  12 and 24 weeks

• Normalization of cortisol circadian rhythm

  baseline, 12 weeks, 24 weeks.

• Changes of thrombotic risk parameters

  Baseline, 12 and 24 weeks

• Changes of lipid profile

  Baseline, 12 and 24 weeks

• Changes of bone turnover markers

  Baseline, 12 and 24 weeks

Study Arms (1)

metyrapone treatment

hypercortisolemic patients taking metyrapone since less than a week (usually 250 mg/day, maximum dose 6000 mg/day)

Drug: Metyrapone Capsules

Interventions

Metyrapone Capsules DRUG

Exposure to 24 weeks of treatment with metyrapone

metyrapone treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypercortisolism referred to the outpatient clinic who were already on metirapone therapy.

You may qualify if:

• Patients with mild Cushing's Syndrome not candidate for surgery
• Current therapy with metyrapone since less than 1 week
• Cortisol levels at 08:00 after 1 mg-overnight dexamethasone suppression test (1mgDST) \>1.8 μg/dL
• Confirmed with 2 mg two days dexamethasone suppression test (2mgx2dDST)
• Presence of at least one out of the following conditions: type 2 diabetes mellitus, impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), arterial hypertension, bone mineral density (BMD) Z-score \< -2.0 and/or fragility fracture at any skeletal site
• Stable anti-hypertensive therapies and blood pressure (BP) levels in the month before enrolment
• Stable anti-diabetic therapies and glycometabolic control during the month before enrolment
• Stable body weight during the month before enrolment

You may not qualify if:

• Signs and/or symptoms of overt hypercortisolism (striae rubrae, moon facies, easy bruising, buffalo hump, hypertrichosis)
• Malignant hypertension and/or BP \<200/120 mmHg
• Severe hyperglycemia (i.e. FG \>350 mg/dL)
• Urinary free cortisol (UFC) higher than 1.5 fold the upper normal range
• Presence of pheochromocytoma or primary hyperaldosteronism
• Possible adrenal metastases or radiological features suggestive for adrenal malignancy (i.e. not homogeneous pattern, necrosis, calcifications, irregular margins, local invasion and high density at computed tomography)
• Congenital adrenal hyperplasia
• Intake of drugs influencing cortisol metabolism and/or secretion
• Women in child-bearing age
• Patients with body mass index (BMI) \>35 kg/m2

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• HRA Pharma: collaborator

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20149, Italy

Location

Related Publications (39)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Cushing Syndrome

Interventions

Metyrapone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chiodini Chiodini, Professor

  Istituto Auxologico Italiano IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 25, 2022
• Study Start: April 28, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)