Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
acromegaly
We aim to define the role of GH action in modifying HCL by regulating hepatic VLDL secretion, DNL and energy metabolism in healthy humans.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 1 Jan 2022 → ongoing
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Austrian Science Fund (FWF)
External identifiers
- EU CT number
- 2024-518214-11-01
- EudraCT number
- 2020-000831-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
We aim to define the role of GH action in modifying HCL by regulating hepatic VLDL secretion, DNL and energy metabolism in healthy humans.
Secondary objectives 2
- We aim to trace D2 enrichments in lipids in liver and adipose tissue by high resolution magnetic resonance spectroscopy (MRS).
- In patients with acromegaly we aim to investigate the effects of GH excess on VLDL secretion and DNL. Of note, individual treatment is independent of all study related activities and is not examined in this study.
Conditions and MedDRA coding
acromegaly
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518214-11-00 | InvestiGating the rOle of Growth Hormone in hepatic lipid metabolism in humans | Medical University Of Vienna |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age between 18 – 70 years
- for healthy volunteers: Plasma trigylcerides: < 300 mg/dl
- for healthy volunteers: male sex
Exclusion criteria 13
- for healthy volunteers: HbA1c > 6%
- history of pancreatitis
- for healthy volunteers: serum TGs > 300 mg/dl
- for healthy volunteers: known liver or kidney disease (AST/ALT > ULN, GFR < 65 ml/min)
- for healthy volunteers: consummation of alcoholic beverages during the last 48 hours
- for healthy volunteers: Body-Mass-Index > 30 kg/m²
- for healthy volunteers: tendency towards claustrophobia
- simultaneous participation in another active clinical study
- allergies against soy products, eggs, peanuts
- for healthy volunteers: metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation [heart pacemaker, coronary stents and heart valves (in case these devices are not compatible with a 7T MT), brain (aneurysm) clip, nerve stimulators, electrodes, ear implants, penile implants, colored contact lenses, patch to deliver medications through the skin, vascular filter for blood clots, orthodontic braces, shunt-spinal or ventricular, any metal implants (rods, joints, plates, pins, screws, nails, or clips), embolization coil, or any metal fragments or shrapnel in the body.
- for patients with acromegaly: serum TGs > 500 mg/dl
- for patients with acromegaly: severe liver disease (LFTs 3x ULN)
- for patients with acromegaly: glomerular filtration rate < 45 mL/min
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- GH induced changes in metabolism of energy rich phosphates (ATP turnover)
Secondary endpoints 6
- GH induced changes in hepatic lipid content
- GH induced changes in VLDL secretion
- GH induced changes in de novo lipogenesis, i.e. the incorporation of D2 into VLDL-TG palmitate and lipid profiling using a DNL index
- GH induced changes in the accumulation of deuterium label in lipid stores, including liver and subcutaneous adipose tissue, as measure of depot specific de novo lipogenesis
- GH induced changes in resting energy expenditure
- GH induced changes in body composition
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SOMAVERT 20 mg powder and solvent for solution for injection
PRD3432998 · Product
- Active substance
- Pegvisomant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01AX01 — -
- Marketing authorisation
- EU/1/02/240/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Genotropin® 12 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
PRD4247915 · Product
- Active substance
- Somatropin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 14 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01AC01 — SOMATROPIN
- Marketing authorisation
- 30032.02.00
- MA holder
- PFIZER PHARMA GMBH
- MA country
- Germany
- 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 Medicine III, Division of Endocrinology and Metabolism
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Medicine III, Division of Endocrinology and Metabolism
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 30 | 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 | 2022-01-01 | 2022-01-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518214-11-00 blackened | 3 |
| Recruitment arrangements (for publication) | Placeholder 2024-518214-11-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_WPA blackened | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_WPB blackened | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_WPC blackened | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Genotropin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Somavert | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-06 | Austria | Acceptable 2025-01-10
|
2025-01-15 |