Overview
Sponsor-declared trial summary
Mild autonomous cortisol secretion in patients with adrenal adenoma
Cardiometabolic phenotyping of patients suffering from autonomous cortisol secretion and identifying a disease specific chronobiology profile in patients with altered hypothalamus-pituitary-adrenal (HPA) axis signaling
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 15 May 2023 → 15 Jan 2025
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512100-19-00
- EudraCT number
- 2022-000161-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Cardiometabolic phenotyping of patients suffering from autonomous cortisol secretion and identifying a disease specific chronobiology profile in patients with altered hypothalamus-pituitary-adrenal (HPA) axis signaling
Secondary objectives 1
- Investigating the impact of a treatment by metyrapone on cardiometabolic risk factors in patients with autonomous adrenal cortisol secretion
Conditions and MedDRA coding
Mild autonomous cortisol secretion in patients with adrenal adenoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Group autonomous cortisol secretion: Inclusion criteria for the ACS group: • Age > 18 years • History of an adrenal adenoma • morning cortisol > 1.8 ug/dl following 1 mg dexamethasone suppression test • No classical clinical features associated with the presence of Cushing’s syndrome, Control group: • Age > 18 years • History of an adrenal adenoma • morning cortisol of ≤ 1.8 ug/dl following 1 mg dexamethasone suppression testing
Exclusion criteria 1
- • HbA1c > 8 % and/or treatment with insulin therapy 14 Proposal_AdrenalClock_V4 18.03.2023 • uncontrolled hypertension (RR > 170/110 mmHg; treatment with no more than 4 antihypertensive drugs) • previous treatment with glucocorticoids within the last 3 months • concomitant treatment with drugs affecting HPA signaling or CYP3A4 metabolism • adrenal tumor with radiological criteria suspicious for malignancy • chronic kidney disease (eGFR < 45 ml/min) • liver disease (ASAT / ALAT > 3 x ULN) • pregnancy or breast feeding • general MR contraindications (claustrophobia, metal devices or other magnetic material in the body which will be hazardous for MR investigation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy
Secondary endpoints 1
- insulin secretion and sensitivity based on validated indices (HOMA_IR, CLIX) • subcutaneous and visceral fat mass, body composition • Systolic and diastolic heart function, epicardial and pericardial fat mass • ectopic lipid deposition in the skeletal muscle and the myocardium • standardized blood pressure measurements (blood pressure for 24h hours and Schellong tests) • parameters of systemic inflammation (CRP, Il-6, PAI-1, TNF-alpha, homocysteine, leucocytes, monocytes)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Metyrapone HRA 250mg soft capsules
PRD8014015 · Product
- Active substance
- Metyrapone Bp
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 6000 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- V04CD01 — METYRAPONE
- Marketing authorisation
- PL 51757/0001
- MA holder
- HRA PHARMA RARE DISEASES
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Endocrinology and Metabolism
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Endocrinology and Metabolism
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-05-15 | 2025-01-15 | 2023-05-15 | 2024-09-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 202200016140_Summary_Study_Results__V1.0_130126 SUM-114647
|
2026-01-14T13:51:24 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 202200016140_Study_Results_lay person summary_V1.0_130126 | 2026-01-14T13:51:43 | Submitted | Laypersons Summary of Results |
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay person summary | 1 |
| Protocol (for publication) | D1_Protocol EU CT 2024-512100-19-00-redacted | 4 |
| Recruitment arrangements (for publication) | Platzhalter | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Adults_1_ redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_2_ redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Metopirone | 1 |
| Summary of results (for publication) | Summary study results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Austria | Acceptable 2024-10-09
|
2024-10-14 |