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

Primary Purpose

Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Placebo

Omega-3 carboxylic acid

Fenofibrate 200mg

Placebo

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease (NAFLD focused on measuring omega-3 carboxylic acid

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

Omega-3 carboxylic acids 4g / day

Fenofibrate 200mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02354976

First Posted

January 30, 2015

Last Updated

September 24, 2018

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02354976

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2015 (Actual)

Primary Completion Date

May 26, 2016 (Actual)

Study Completion Date

May 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia

Keywords

omega-3 carboxylic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Omega-3 carboxylic acids 4g / day

Arm Type

Experimental

Arm Title

Fenofibrate 200mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to Omega-3 carboxylic acids (olive oil)

Intervention Type

Drug

Intervention Name(s)

Omega-3 carboxylic acid

Intervention Description

4 g administered as 4 x 1 g capsules

Intervention Type

Drug

Intervention Name(s)

Fenofibrate 200mg

Intervention Description

200mg capsule administered once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to fenofibrate 200mg

Primary Outcome Measure Information:

Title

Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)

Description

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.

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)

Description

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.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Lind, Professor

Organizational Affiliation

Uppsala University Hospital. Uppsala Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Research Site

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

11324

Country

Sweden

Facility Name

Research Site

City

Uppsala

ZIP/Postal Code

75237

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

30197273

Citation

Oscarsson J, Onnerhag K, Riserus U, Sunden M, Johansson L, Jansson PA, Moris L, Nilsson PM, Eriksson JW, Lind L. Effects of free omega-3 carboxylic acids and fenofibrate on liver fat content in patients with hypertriglyceridemia and non-alcoholic fatty liver disease: A double-blind, randomized, placebo-controlled study. J Clin Lipidol. 2018 Nov-Dec;12(6):1390-1403.e4. doi: 10.1016/j.jacl.2018.08.003. Epub 2018 Aug 10.

Results Reference

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

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