Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

NCT00959842 | Completed Phase 1 Results

• 2 other identifiers: LVZ 112860GSK - LVZ 112860
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Conditions

Hypertriglyceridemia

Keywords

hypertriglyceridemia; Omega-3 Fatty Acids; Lipoprotein; Statin; Lovaza

Outcome Measures

Primary Outcomes (1)

• HDL 15-HEPE

  high density lipoprotein level of 15-HEPE

  4 months

Study Arms (1)

Lovaza

EXPERIMENTAL

Lovaza was given as the only agent; there was no comparator agent or arm

Drug: Lovaza

Interventions

Lovaza DRUG

1 gram gel capsule 4 capsules per day for 8 weeks

Also known as: Omega-3 Fatty Acid, fish oil, Omacor

Lovaza

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Stable does of statins ≥ 8 weeks prior to screening
• Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis)
• Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and \< 500 mg/dL
• Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal

You may not qualify if:

• Poorly controlled diabetes mellitus (e.g. \[HbA1c\] \> 8.0%)
• History of a cardiovascular event
• Past revascularization procedure
• Past aortic aneurysm or an aortic dissection \< 6 months prior to screening
• History of pancreatitis
• Sensitivity to any statin OR to omega-3 fatty acids or fish products
• Poorly controlled hypertension (i.e.: \>=160 systolic (resting) and/or \>=100 diastolic (resting)) at 2 consecutive visits
• Serum Creatinine ≥ 2.0 mg/dL
• Serum transaminase \> 1.5 × upper limit of normal (ULN); including aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]; 31 U/L for AST, 45 U/L for ALT
• Creatine Kinase (CK) \> 3.0 × ULN
• Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day
• Contraindications for Lovaza per product insert
• Women who are pregnant or nursing

Sponsors & Collaborators

• Sanford Research: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Sanford Research/USD

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (1)

• Newman JW, Pedersen TL, Brandenburg VR, Harris WS, Shearer GC. Effect of omega-3 fatty acid ethyl esters on the oxylipin composition of lipoproteins in hypertriglyceridemic, statin-treated subjects. PLoS One. 2014 Nov 13;9(11):e111471. doi: 10.1371/journal.pone.0111471. eCollection 2014.

  PMID: 25393536 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Omacor; Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Dr. Greg Shearer
• Organization: Professor

gcs13@psu.edu

814-867-3040

Study Officials

• Gregory C Shearer, PhD

  Sanford Research/USD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Senior Scientist

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-09

Locations

US (1)