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New treatment option for Adrenal Incidentalomas
Official title Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome
ClinicalTrials.gov ID: NCT06801249
What this study is testing
What is Metarapone?
Metarapone is an investigational medicine, given as an once-weekly, being studied as a potential treatment for adrenal incidentalomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- run-in (phase 1)
- Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms \>5 mm on abdominal CT scan
- SCS (detected 2 times in the 6 months before run-in) defined by the absence of catabolic signs of Cushing's syndrome in association with any of these...
- Cortisol levels after dexamethasone 1 mg test \>50 nmol/L associated with baseline ACTH \<10 pg/mL
- Cortisol levels after dexamethasone 1 mg test \>50 nmol/L associated with increased nocturnal (11 pm) salivary cortisol
You likely can't join if
- Body mass index ≥40 kg/m2
- Pregnant or lactating women; diagnosis of pregnancy will be made by serum β-HCG assay
- Women of childbearing age using contraceptive measures other than barrier contraception. Barrier contraceptive measures are: o Male or female condom...
- Treatment with steroids in the last year before enrollment
- Taking medications known to interfere with Metirapone
- Known or suspected hypersensitivity to the drug or drug class under study
See the full eligibility criteria
- run-in (phase 1)
- Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms \>5 mm on abdominal CT scan
- SCS (detected 2 times in the 6 months before run-in) defined by the absence of catabolic signs of Cushing's syndrome in association with any of these 3 conditions:
- Cortisol levels after dexamethasone 1 mg test \>50 nmol/L associated with baseline ACTH \<10 pg/mL
- Cortisol levels after dexamethasone 1 mg test \>50 nmol/L associated with increased nocturnal (11 pm) salivary cortisol
- Cortisol levels after dexamethasone 1 mg test \>138 nmol/L
- Hypertension (BP ≥140/90 mmHg and/or ongoing antihypertensive treatment)
- Patients who cannot undergo surgery
- Acquisition of informed consent.
- randomization (phase 2) \- BP \>100/60 mmHg and \<130/85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.
- Body mass index ≥40 kg/m2
- Pregnant or lactating women; diagnosis of pregnancy will be made by serum β-HCG assay
- Women of childbearing age using contraceptive measures other than barrier contraception. Barrier contraceptive measures are: o Male or female condom with or without spermicide o Cervical cup, diaphragm or sponges with...
- Treatment with steroids in the last year before enrollment
- Taking medications known to interfere with Metirapone
- Known or suspected hypersensitivity to the drug or drug class under study
- Patients with serious clinical conditions that, in the opinion of the Investigator, contraindicate the patient's participation in the study
- Patients with primary corticosurrenal insufficiency, impaired adrenal secretion, and severe hypopituitarism
- Patients with impaired liver function
- Patients with untreated hypothyroidism or being treated with drugs that have an action on the hypothalamic-pituitary-adrenal axis
- Patients with hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 of the RCP - Metirapone.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
- Naples, Italy
- Padova, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy; Naples, Italy; Padova, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.