A double-blind randomized placebo-controlled, parallel-group 12 week study to investigate the effects of Epanova® compared to placebo and compared to Fenofibrate on liver Fat content in hypertriglyceridemic overwEight subjeCTs; EFFECT I - Effect I

AstraZenenca AB0 个研究点开始时间: 2015年1月23日最近更新: 2017年5月22日

试验速览

暂无简介。

•- Provision of informed consent
•- Men or women =40 years and =75 years with suitable veins for cannulation or repeated venepuncture
•- Have serum triglycerides =1.7mM
•- Have liver fat content as assessed by MRI >5.5%
•- Have a body mass index (BMI) >25 and =40 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•- History of or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
•- Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula).
•- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
•- Total bilirubin >2.0 mg/dL (34.2 µmol/L)
•- Type 2 diabetes, as defined by WHO criteria e.g. fasting plasma Glucose >7.0mM or use of antidiabetic therapy
•- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
•- Elevated NAFLD fibrosis score >0.675
•- Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse was to be defined as >14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard liquor) or as judged by the investigator

发起方

AstraZenenca AB