HypercholesterolemiaNCT00388180
An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
An observational study of Hypercholesterolemia and Dyslipidaemias, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Dyslipidaemias, Obesity
- What is being tested?
- GW501516 and GW590735
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to not given
- Phase
- Observational
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index in the range of 27 - 43 kg/m2
- Waist circumference > 95cm
Who cannot join
- Clinically relevant abnormalities on screening ECG/holter, labs or medical examination
- Use of tobacco within 6 months of the study
- Regular strenuous exercise
- Use of prescription or non-prescription medications, including vitamins and herbal/dietary supplements
- LDL < 80mg/dL; TG <100mg/dL or >400mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Baton Rouge, Louisiana, 70808
About this study
Official title: A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of 12-week Treatment With GW590735X (20ug) or GW501516X (10mg) Relative to Placebo on Measures of Adiposity and Inflammation in Overweight and Obese Subjects
The investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. There are also data to suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation. These and other activities of PPARs are being further explored in this clinical study.
- Conditions
- Hypercholesterolemia, Dyslipidaemias, Obesity
- Being tested
- GW501516, GW590735
- Keywords
- cholesterol, inflammation, fat
- Medical subject headings
- Hypercholesterolemia, Obesity, Inflammation, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW501516Drug
GW590735Drug
Also called GW501516
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat levels
Secondary outcomes (1)
Levels of multiple proteins/biomarkers in blood and fat tissue, as well as specific lipid in muscle and liver (via imaging). Gene expression in blood and fat tissue.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
- Study startDec 2004
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 HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388180
- Sponsor's protocol ID
- PAD100958
- Status last verified
- Feb 2011
- First submitted
- 13 Oct 2006
- Last updated
- 19 Mar 2012
- Results posted
- No
Publications
Olson EJ, Pearce GL, Jones NP, Sprecher DL. Lipid effects of peroxisome proliferator-activated receptor-delta agonist GW501516 in subjects with low high-density lipoprotein cholesterol: characteristics of metabolic syndrome. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2289-94. doi: 10.1161/ATVBAHA.112.247890. Epub 2012 Jul 19.
PubMed 22814748
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of 12-week Treatment With GW590735X (20ug) or GW501516X (10mg) Relative to Placebo on Measures of Adiposity and Inflammation in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT00388180
- Acronym / sponsor ID
- PAD100958
- Conditions
- Hypercholesterolemia, Dyslipidaemias, Obesity
- Keywords
- cholesterol, inflammation, fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- First posted
- 16 Oct 2006 (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 investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. There are also data to suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation. These and other activities of PPARs are being further explored in this clinical study.
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index in the range of 27 - 43 kg/m2
- Waist circumference > 95cm
Key exclusion criteria (5 listed)
- Clinically relevant abnormalities on screening ECG/holter, labs or medical examination
- Use of tobacco within 6 months of the study
- Regular strenuous exercise
- Use of prescription or non-prescription medications, including vitamins and herbal/dietary supplements
- LDL < 80mg/dL; TG <100mg/dL or >400mg/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 |
|---|---|---|
| GW501516 | Drug | – |
| GW590735Also: GW501516 | Drug | – |
Primary outcome
Body fat levels
1 secondary outcome
Levels of multiple proteins/biomarkers in blood and fat tissue, as well as specific lipid in muscle and liver (via imaging). Gene expression in blood and fat tissue.
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 19 Mar 2012.
- Derived from this study: PubMed 22814748Olson EJ, Pearce GL, Jones NP, Sprecher DL. Lipid effects of peroxisome proliferator-activated receptor-delta agonist GW501516 in subjects with low high-density lipoprotein cholesterol: characteristics of metabolic syndrome. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2289-94. doi: 10.1161/ATVBAHA.112.247890. Epub 2012 Jul 19.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Dyslipidaemias, run by GlaxoSmithKline 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 5 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 19 Mar 2012. 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.
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?
Body fat levels. 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 NCT00388180, 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 19 Mar 2012.