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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354976
• Other study ID #: D5881C00007
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2015
• Est. completion date: May 26, 2016

Study information

• Verified date: September 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 26, 2016
• Est. primary completion date: May 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hypertriglyceridemia
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease (NAFLD
• Overweight

Intervention

Drug:
• Placebo
Placebo matching to Omega-3 carboxylic acids (olive oil)
• Omega-3 carboxylic acid
4 g administered as 4 x 1 g capsules
• Fenofibrate 200mg
200mg capsule administered once daily
• Placebo
Placebo matching to fenofibrate 200mg

Locations

Country	Name	City	State
Sweden	Research Site	Göteborg
Sweden	Research Site	Malmö
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)	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.	Baseline and 12 weeks
Secondary	Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)	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.	12 weeks