← Back to Search

Omega-3 Fatty Acid

Lovaza for Non-alcoholic Fatty Liver Disease

Phase 4
Waitlist Available
Led By Edward A Mena, MD
Research Sponsored by Huntington Medical Research Institutes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine if Lovaza improves fibrosis and the NASH activity index.
Secondary outcome measures
To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LovazaActive Control1 Intervention
Single blind, active treatment arm Lovaza, is the only fish oil supplement approved by the FDA. The Lovaza treatment group will take 4g of Lovaza daily for a minimum of 48 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Single blind, Placebo arm study drug will contain 994.0 mg of corn oil and 6mg of alpha tocopherol as an excipient in a soft gelatin capsule shell. Subjects will take 4g daily for a minimum of 48 weeks.

Find a Location

Who is running the clinical trial?

Huntington Medical Research InstitutesLead Sponsor
5 Previous Clinical Trials
465 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,751 Previous Clinical Trials
8,067,432 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
705 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Myron J Tong, PhD, MD.Study DirectorHuntington Medical Research Institutes - Liver Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
2009. "Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00941642.
All > Liver Fibrosis
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top