A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.

Phase 2

Completed

• Conditions: Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: Omega-3 carboxylic acid; Drug: Fenofibrate 200mg

• Registration Number: NCT02354976
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-03
• Study Start: 2015-09-01
• Primary Completion: 2016-05-26
• Study Completion: 2016-05-26
• Results First Submitted: 2017-05-05
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Results First Posted: 2018-09-25
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Omega-3 carboxylic acids 4g / day	Omega-3 carboxylic acid	-
Fenofibrate 200mg	Fenofibrate 200mg	-

Primary Outcome Measures

Name	Time	Method
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)	Baseline and 12 weeks	To evaluate the efficacy of Epanova compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)	12 weeks	To evaluate the efficacy of Epanova compared to Fenofibrate with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden