NCT00941642

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

Status unknown Phase 4 Last updated 9 June 2010

What this trial tests

Phase 4 trial testing Lovaza in Non-Alcoholic Fatty Liver Disease in 40 participants. Status unknown.

Timeline

1 September 2009

Primary endpoint
1 September 2012

1 September 2012

Quick facts

Lead sponsor	Huntington Medical Research Institutes
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 September 2009
Primary completion	1 September 2012
Estimated completion	1 September 2012
Sites	1 location across United States

Drugs / interventions tested

• Lovaza — full drug profile →
• placebo control

Conditions studied

• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →

Sponsor

Huntington Medical Research Institutes

Who can join

18 and older, any sex, with Non-Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To determine if Lovaza improves fibrosis and the NASH activity index.
  Time frame: 48 weeks

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current status of novel antifibrotic therapies in patients with chronic liver disease.
   Cohen-Naftaly M, Friedman SL. · · 2011 · cited 129× · PMID 22043231 · DOI 10.1177/1756283x11413002
2. A Molecular Insight into the Role of Antioxidants in Nonalcoholic Fatty Liver Diseases.
   Ezhilarasan D, Lakshmi T. · · 2022 · cited 34× · PMID 35602098 · DOI 10.1155/2022/9233650
3. Nutritional supplementation for nonalcohol-related fatty liver disease: a network meta-analysis.
   Komolafe O, Buzzetti E, Linden A, Best LM, et al · · 2021 · cited 12× · PMID 34280304 · DOI 10.1002/14651858.cd013157.pub2
4. Killing hepatocellular carcinoma in the NAFLD/NASH stage: a comprehensive perspective on targeting regulated cell death.
   Xi J, Lei S, Chen J, Liu J, et al · · 2025 · cited 3× · PMID 40537476 · DOI 10.1038/s41420-025-02558-x