Pegvisomant for Acromegaly | Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Age between 18 – 70 years"}
• {"criterion_text":"- for healthy volunteers: Plasma trigylcerides: < 300 mg/dl"}
• {"criterion_text":"- for healthy volunteers: male sex"}

Exclusion criteria

• {"criterion_text":"- for healthy volunteers: HbA1c > 6%"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- for patients with acromegaly: serum TGs > 500 mg/dl"}
• {"criterion_text":"- for patients with acromegaly: severe liver disease (LFTs 3x ULN)"}
• {"criterion_text":"- for patients with acromegaly: glomerular filtration rate < 45 mL/min"}
• {"criterion_text":"- history of pancreatitis"}
• {"criterion_text":"- for healthy volunteers: serum TGs > 300 mg/dl"}
• {"criterion_text":"- for healthy volunteers: known liver or kidney disease (AST/ALT > ULN, GFR < 65 ml/min)"}
• {"criterion_text":"- for healthy volunteers: consummation of alcoholic beverages during the last 48 hours"}
• {"criterion_text":"- for healthy volunteers: Body-Mass-Index > 30 kg/m²"}
• {"criterion_text":"- for healthy volunteers: tendency towards claustrophobia"}
• {"criterion_text":"- simultaneous participation in another active clinical study"}
• {"criterion_text":"- allergies against soy products, eggs, peanuts"}

Primary endpoints

• {"endpoint_text":"- GH induced changes in metabolism of energy rich phosphates (ATP turnover)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- GH induced changes in hepatic lipid content","definition_or_measurement_approach":""}
• {"endpoint_text":"- GH induced changes in VLDL secretion","definition_or_measurement_approach":""}
• {"endpoint_text":"- GH induced changes in de novo lipogenesis, i.e. the incorporation of D2 into VLDL-TG palmitate and lipid profiling using a DNL index","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":""}
• {"endpoint_text":"- GH induced changes in resting energy expenditure","definition_or_measurement_approach":""}
• {"endpoint_text":"- GH induced changes in body composition","definition_or_measurement_approach":""}

Austria

Earliest CTIS Part Ii Submission Date

06-12-2024

Latest Decision Or Authorization Date

15-01-2025

Processing Time Days

40

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"Austria","full_name":"Austrian Science Fund (FWF)","duties_or_roles":"Source of monetary support / funder","organisation_type":"Funding Agency"}
• {"country":"Liechtenstein","full_name":"PFIZER EUROPE MA EEIG","duties_or_roles":"Marketing authorisation holder for SOMAVERT (product listed in trial)","organisation_type":"Commercial (marketing authorisation holder)"}
• {"country":"Germany","full_name":"PFIZER PHARMA GMBH","duties_or_roles":"Marketing authorisation holder for Genotropin (product listed in trial)","organisation_type":"Commercial (marketing authorisation holder)"}