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Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease

NCT00941642 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-06-10

No results posted yet for this study

Summary

Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription for the treatment of hypertriglyceridemia (\> 500 mg/dl). The primary mechanism appears to be a reduction in hepatic production of triglycerides. Also decreases the hepatic production of very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is two fold. It would help in the decrease production of triglycerides by the liver and have antioxidant properties decreasing the production of free radicals in the liver. In doing so, steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Lovaza

Approximately 50% of study subjects will be randomized to the active treatment arm -Lovaza. Subjects will be dosed with 4g of Lovaza gel capsules daily for a minimum of 48 weeks duration.

DRUG

placebo control

Approximately 50% of study subjects will be randomized to the placebo arm of this study. Placebo arm subjects will receive 4g of placebo gel caps daily for a minimum of 48 weeks duration.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Huntington Medical Research Institutes

    lead OTHER

Principal Investigators

  • Edward A Mena, MD · Huntington Medical Research Institutes - Liver Center

  • Myron J Tong, PhD, MD. · Huntington Medical Research Institutes - Liver Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941642 on ClinicalTrials.gov