Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia

Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180764

Enrollment

Registered

2010-08-12

Start date

2010-08-31

Completion date

2012-10-31

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

hypertriglyceridemia, omega-3 acid ethyl esters, high-density lipoproteins, fish oil

Brief summary

Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the good cholesterol) work better. Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels. Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.

Interventions

DRUGLovaza (Omega-3 acid ethyl esters)

1g capsules, 4 capsules po daily

DRUGPlacebo

Placebo matching active lovaza, 1 g capsules, 4 capsules po daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below) * Age 35-75 years

Exclusion criteria

* Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months * Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted) * Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total) * Excess ethanol consumption (regular intake \>4 drinks/d, or binges of \>8 drinks at once for men, half these levels for women) * Poorly controlled diabetes mellitus (A1c \>9%) * History of acute or chronic pancreatitis * Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis * History of significant unexplained or uncontrolled bleeding or bruising * Poorly controlled blood pressure (\>140/90mmHg, with or without treatment) * Poorly controlled thyroid disease (TSH outside of normal range) * Hepatic disease (ALT \> 2.5x ULN, Dx of hepatitis or cirrhosis) * Any contraindication or prior adverse reaction to Lovaza * Active cancer (except basal cell or squamous cell skin cancer) * Pregnancy, plan/desire to become pregnant, breast feeding * Inability or unwillingness to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
HDL Composition	12 weeks	HDL composition (protein and lipid) by size (gel filtration column)

Secondary

Measure	Time frame	Description
HDL cholesterol composition by density subfraction	12 weeks	HDL composition by density gradient ultracentrifugation
Safety	12 weeks	Transaminases and glucose levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026