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Lovaza Mechanisms of Action

This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Jorge Plutzky, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01301794
First received: February 18, 2011
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.


Condition Intervention Phase
Moderate Hypertriglyceridemia.
 Dietary Supplement: Omega 3 fatty acid (Lovaza)
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Enrolled subjects will serve as their own controls and will be studied at baseline and after 3 months of Lovaza. The primary endpoint will test changes in lipoproteins as a function of their content and ability to activate PPAR-alpha in standard transfected cell culture systems.


Secondary Outcome Measures:
  • Changes in plasma markers for atherosclerosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Subjects will also be studied before and after Lovaza for changes in lipid profile and c- reactive protein

  • Change in plasma markers of diabetes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Plasma markers of diabetes will be measure before and after Lovaza treatment for 3 months, specifically glucose and A1C levels

  • Changes in plasma markers of liver function [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Plasma levels of liver function tests, specifically ALT and AST before and after 3 months of Lovaza.

    This is not a safety issue since elevated triglycerides can cause increased liver function tests and fish oil (like Lovaza) can lower triglyceride levels and hence ALT and AST levels.



Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Omega 3 fatty acid (Lovaza)
    Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day).
    Other Names:
    • Lovaza LVZ112737, formerly known as Omacor.
    • Omega 3 fatty acids are also available over the counter but Lovaza is a proprietary form.
Detailed Description:

This study will investigate changes in lipid and other metabolic parameters as well as the ability of isolated lipoproteins to activate PPARs in the presence or absence of lipoprotein lipase in a cohort of normal healthy individuals with modest hypertriglyceridemia before and after a course of Lovaza.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy 21 to 65 year old men and women
  • Triglycerides >150 < 500 mg/dL

Exclusion Criteria:

  • Other lipid lowering medication including fish oil
  • Major illnesses
  • Diabetes
  • Cardiovascular disease
  • Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides > 500 mg/dL
  • Indication for immediate statin therapy
  • Pregnancy
  • Contraindication for fish oil use or muscle biopsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301794

Contacts
Contact: Jorge Plutzky, MD 617-525-4360 jplutzky@rics.bwh.harvard.edu
Contact: Jon Brown, MD 617-525-4360 jbrown0@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sutanuka Lahiri     617-525-6823     Sutanuka Lahiri <SLAHIRI@PARTNERS.ORG>    
Contact: Jorge Plutzky     326-055-200     jplutzky@rics.bwh.harvard.edu    
Sponsors and Collaborators
Brigham and Women's Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Jorge Plutzky, MD Brigham and Women's Hospital
Study Director: Jonathan Brown, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Jorge Plutzky, Director of Vascular Disease Prevention Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01301794     History of Changes
Other Study ID Numbers: BWHp001640
Study First Received: February 18, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Hypertriglyceridemia
Fish oil
Omega 3 fatty acids

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013