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

NCT ID: NCT00941642

Last Updated: 2010-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

placebo control

Intervention Type: DRUG

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.

Lovaza

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 Type: ACTIVE_COMPARATOR

Lovaza

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Over the age of 18
• Abnormal liver enzymes >40 IU/L. Definition of normal is ALT 19 for a woman and 30 for a man.
• Patients must meet ATP III criteria for metabolic syndrome: Central obesity as measured by waist circumference. Men - greater than or equal to 40 inches. Women - greater than or equal to 35 inches.
• Blood HDL cholesterol. Men - less than 40 mg/dL. Women - less than 50 mg /dL.
• Blood pressure greater than or equal to 130/85.
• Fasting glucose greater than or equal to 100 mg/dL but less than 126mg/dL on 2 separate occasions.
• Fasting blood triglycerides greater than or equal to 150 mg/dL.
• Hepatitis B and C negative
• Autoimmune Hepatitis, Wilson's Disease, Hemochromatosis negative, etc.
• NASH or NAFLD on biopsy of any degree:

Exclusion Criteria

• Below the age of 18.
• Other Causes of Liver inflammation.
• Daily alcohol consumption in excess of 20 grams / day for men and 10 grams / day for women. If participant unable to quantify his/her alcohol intake, they should be excluded.
• Taking a prescribed medication know to cause fatty liver disease 6 months prior to enrollment. Also, subjects with secondary causes of fatty liver disease (ie. Gastric bypass) should be excluded from the study.
• Cirrhosis.
• Subjects on oral insulin-sensitizing agents and other drugs currently being used in the treatment of NAFLD. Such agents include fibrates, Vitamin E, S-adenosyl-methionine, betaine, N-acetylcysteine, and milk thistle extracts.
• Diabetes (fasting sugar above 126mg/dl).
• Pregnancy or lactation. Women of child bearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test prior to treatment and be practicing an acceptable form of barrier contraception for the duration of the study.
• Any serious or chronic disease that in the opinion of the Principal Investigator (PI), may affect the assessment of safety or efficacy parameters. This includes but is not limited to, patients with malignancy, other than Basal Cell Carcinomas.
• Patients who, in the opinion of the site PI, are not suitable candidates for enrollment or would not comply with the requirements of the study.
• Patients who have had a liver transplant.
• Any allergy to fish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Huntington Medical Research Institutes

OTHER

Sponsor Role: lead

Responsible Party

Huntington Medical Research Institutes

Principal Investigators

Edward A Mena, MD

Role: PRINCIPAL_INVESTIGATOR

Huntington Medical Research Institutes - Liver Center

Myron J Tong, PhD, MD.

Role: STUDY_DIRECTOR

Huntington Medical Research Institutes - Liver Center

Locations

HMRI - Liver Center

Pasadena, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roberta A Fitzgerald, RN

Role: CONTACT

robertaf@hmri.org

626.397.5825

Facility Contacts

Roberta A Fitzgerald, RN

Role: primary

robertaf@hmri.org

626-397-5825

Other Identifiers

IND # 105,085.

Identifier Type: -

Identifier Source: secondary_id

LOVAZA - NAFLD

Identifier Type: -

Identifier Source: org_study_id