A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia
Intervention: Placebo (Drug); Omega-3 carboxylic acid (Drug); Fenofibrate 200mg (Drug); Placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Lars Lind, Professor, Principal Investigator, Affiliation: Uppsala University Hospital. Uppsala Sweden
Overall contact: AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Summary
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study
performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and
fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with
over-weight and hypertriglyceridemia.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Difference from baseline to week 12 in the % liver fat content as measured by MRI.
Secondary outcome: Difference from baseline to week 12 in the % liver fat content as measured by MRI.
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: - Provision of informed consent
- Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated
venepuncture
- Have serum triglycerides ≥1. 7 mM
- Have liver fat content as assessed by MRI >5. 5%
- Have a body mass index (BMI) >25 and ≤40 kg/m2
, Exclusion Criteria: - 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. 0 mM or
use of antidiabetic therapy
- Any clinically significant abnormalities in clinical chemistry, haematology or
urinalysis results as judged by the investigator. This includes signs of liver
disease other than NAFLD that motivates further investigations of treatment based on
clinical judgement
- 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
Locations and Contacts
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Research Site, Göteborg, Sweden; Not yet recruiting
Research Site, Malmö, Sweden; Not yet recruiting
Research Site, Uppsala, Sweden; Not yet recruiting
Additional Information
Starting date: August 2015
Last updated: July 29, 2015
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