Moderate Hypertriglyceridemia.Phase 4NCT01301794
Lovaza Mechanisms of Action
A Phase 4 study testing Omega 3 fatty acid (Lovaza) in people with Moderate Hypertriglyceridemia., run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Hypertriglyceridemia.
- What is being tested?
- Omega 3 fatty acid (Lovaza)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otherwise healthy 21 to 65 year old men and women
- Triglycerides >150 < 500 mg/dL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Sutanuka Lahiri, 617-525-6823, Sutanuka Lahiri <SLAHIRI@PARTNERS.ORG>
Jorge Plutzky, 326-055-200, jplutzky@rics.bwh.harvard.edu
About this study
Official title: Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects
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.
Read the 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.
- Conditions
- Moderate Hypertriglyceridemia.
- Being tested
- Omega 3 fatty acid (Lovaza)
- Keywords
- Hypertriglyceridemia, Fish oil, Omega 3 fatty acids
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acid (Lovaza)Dietary supplement
Also called Lovaza LVZ112737, formerly known as Omacor., Omega 3 fatty acids are also available over the counter but Lovaza is a proprietary form.
Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day).
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.
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.
Measured: 3 months
Secondary outcomes (3)
Changes in plasma markers for atherosclerosis
Subjects will also be studied before and after Lovaza for changes in lipid profile and c- reactive protein
Measured: 3 months
Change in plasma markers of diabetes
Plasma markers of diabetes will be measure before and after Lovaza treatment for 3 months, specifically glucose and A1C levels
Measured: 3 months
Changes in plasma markers of liver function
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Hypertriglyceridemia.Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Jorge Plutzky, Brigham and Women's Hospital
- Investigators
- Jorge Plutzky, MD, Principal investigator, Brigham and Women's HospitalJonathan Brown, MD, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301794
- Sponsor's protocol ID
- BWHp001640
- Status last verified
- Feb 2013
- First submitted
- 18 Feb 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects
- ClinicalTrials.gov ID
- NCT01301794
- Acronym / sponsor ID
- BWHp001640
- Conditions
- Moderate Hypertriglyceridemia.
- Keywords
- Hypertriglyceridemia, Fish oil, Omega 3 fatty acids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Otherwise healthy 21 to 65 year old men and women
- Triglycerides >150 < 500 mg/dL
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acid (Lovaza)Also: Lovaza LVZ112737, formerly known as Omacor., Omega 3 fatty acids are also available over the counter but Lovaza is a proprietary form.Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day). | Dietary supplement | – |
Primary outcome
Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.
Time frame: 3 months
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.
3 secondary outcomes
Changes in plasma markers for atherosclerosis
Time frame: 3 months
Change in plasma markers of diabetes
Time frame: 3 months
Changes in plasma markers of liver function
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Plutzky, MD principal investigator
Brigham and Women's Hospital
Jonathan Brown, MD study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega 3 fatty acid (Lovaza) in people with Moderate Hypertriglyceridemia., run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Plutzky, MD (617-525-4360, jplutzky@rics.bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.