DyslipidemiaPhase 2NCT00116519
A Study in People With Abnormal Fat Levels in the Blood
A Phase 2 study testing PPAR alpha in people with Dyslipidemia, run by Eli Lilly and Company at 54 sites in United States.
Trial summary
The purposes of this study are to determine: The safety of the study medication and any side effects that might be associated with it; Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG); How much of the study medication should be given… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- PPAR alpha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 54 sitesUnited States
- Study dates
- Jul 2005to Oct 2006
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 80 years of age
- People with abnormal fat levels in the blood (low HDL, high TG)
Who cannot join
- People with diabetes
- People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
- People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
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Auburn, Maine, 04210
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Baltimore, Maryland, 21208
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Bend, Oregon, 97701
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Benzonia, Michigan, 49616
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Brandon, Florida, 33511
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Bristol, Tennessee, 37620
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Cadillac, Michigan, 49601
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Charlotte, North Carolina, 28262
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Chicago, Illinois, 60607
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Cleveland, Ohio, 44195
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Columbia, South Carolina, 29201
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Danville, Pennsylvania, 17822
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East Cleveland, Ohio, 44112
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Excelsior Springs, Missouri, 64024
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Fayetteville, Arkansas, 72703
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Flint, Michigan, 48532
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Golden, Colorado, 80401
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Grand Forks, North Dakota, 58201
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Greensboro, North Carolina, 27401
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Greer, South Carolina, 29651
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High Point, North Carolina, 27262
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Highlands Ranch, Colorado, 80130
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Hoover, Alabama, 35216
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Houston, Texas, 77024
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Interlochen, Michigan, 49643
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Jeffersonville, Indiana, 47130
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Jupiter, Florida, 33458
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Kansas City, Kansas, 66160
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Kingsport, Tennessee, 37660
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Kissimmee, Florida, 34741
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Las Vegas, Nevada, 89146
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Lexington, Kentucky, 40504
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Littleton, Colorado, 80120
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Longwood, Florida, 32779
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Oviedo, Florida, 32765
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Philadelphia, Pennsylvania, 19115
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Portland, Oregon, 97225
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Raleigh, North Carolina, 27609
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Red Lion, Pennsylvania, 17356
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Rockville, Maryland, 20854
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San Diego, California, 92128
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Simpsonville, South Carolina, 29681
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Spokane, Washington, 99204
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Stoneboro, Pennsylvania, 16153
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Tupelo, Mississippi, 38801
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Vista, California, 92083
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Wenatchee, Washington, 98801
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West Des Moines, Iowa, 50266
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West Seneca, New York, 14224
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Westfield, New York, 14787
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Wichita, Kansas, 67208
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Wilmington, North Carolina, 28412
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Winston-Salem, North Carolina, 27103
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Ypsilanti, Michigan, 48197
About this study
Official title: PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly
The purposes of this study are to determine:
- The safety of the study medication and any side effects that might be associated with it;
- Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG);
- How much of the study medication should be given to patients;
- How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.
- Conditions
- Dyslipidemia
- Being tested
- PPAR alpha, placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPAR alphaDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks
Secondary outcomes (3)
Effects on LDL-C after 12 weeks
Effects on biomarkers of atherosclerosis after 12 weeks
Effects on factors of metabolic syndrome after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startJul 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116519
- Sponsor's protocol ID
- 5750
- Other IDs
- H8D-MC-EMBB
- Status last verified
- Jan 2007
- First submitted
- 29 Jun 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Publications
Nissen SE, Nicholls SJ, Wolski K, Howey DC, McErlean E, Wang MD, Gomez EV, Russo JM. Effects of a potent and selective PPAR-alpha agonist in patients with atherogenic dyslipidemia or hypercholesterolemia: two randomized controlled trials. JAMA. 2007 Mar 28;297(12):1362-73. doi: 10.1001/jama.297.12.1362. Epub 2007 Mar 25.
PubMed 17384435
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly
- ClinicalTrials.gov ID
- NCT00116519
- Acronym / sponsor ID
- 5750
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Oct 2006
- First posted
- 30 Jun 2005 (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.
The purposes of this study are to determine:
- The safety of the study medication and any side effects that might be associated with it;
- Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG);
- How much of the study medication should be given to patients;
- How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women between 18 and 80 years of age
- People with abnormal fat levels in the blood (low HDL, high TG)
Key exclusion criteria (3 listed)
- People with diabetes
- People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
- People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months
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 |
|---|---|---|
| PPAR alpha | Drug | – |
| placebo | Drug | – |
Primary outcome
Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks
3 secondary outcomes
Effects on LDL-C after 12 weeks
Effects on biomarkers of atherosclerosis after 12 weeks
Effects on factors of metabolic syndrome after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2007.
- Derived from this study: PubMed 17384435Nissen SE, Nicholls SJ, Wolski K, Howey DC, McErlean E, Wang MD, Gomez EV, Russo JM. Effects of a potent and selective PPAR-alpha agonist in patients with atherogenic dyslipidemia or hypercholesterolemia: two randomized controlled trials. JAMA. 2007 Mar 28;297(12):1362-73. doi: 10.1001/jama.297.12.1362. Epub 2007 Mar 25.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPAR alpha in people with Dyslipidemia, run by Eli Lilly and Company at 54 sites 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 3 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: finished, as of the sponsor's last update on 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on HDL-C and Triglycerides after 12 weeks. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00116519, which also lists 1 linked publication.
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 26 Jan 2007.