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CompletedNCT00841217Updated Feb 11, 2009

Regulation of Lipoprotein Transport in Metabolic Syndrome

A Phase 4 interventional study of GW501516 and placebo pill in Obesity, Lipid Disorders and Cardiovascular Disease, sponsored by The University of Western Australia. Completed at 1 site in Australia. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-02-11.

Sponsored by The University of Western Australia · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

Read the detailed description

The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD). Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated. We therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.

02

Conditions studied

  • Obesity
  • Lipid Disorders
  • Cardiovascular Disease

Keywords

  • Drug treatment
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 13 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

The University of Western Australia is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Any three of the following:

    • Waist circumference > 102 cm
    • Triglycerides > 150 mg/dL
    • HDL-cholesterol \< 40 mg/dL
    • Blood glucose > 110 mhg/dL
    • Blood pressures > 130/85 mmHg

Exclusion criteria

Exclusion Criteria:

  • Triglycerides > 500 mg/dL
  • Diabetes mellitus
  • CVD
  • Consumption of > 30 g alcohol/day
  • Use of agents affecting lipid metabolism
  • APOE2/E2 genotype
  • Creatinemia (> 120 umol/L)
  • Hypothyroidism
  • Abnormal liver and muscle enzymes
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Placebo comparator
    1

    placebo group

    Drug: placebo pill

  • Active comparator
    2

    GW501516, 2.5mg

    Drug: GW501516

Interventions

  • DrugGW501516

    2.5mg/day

  • Drugplacebo pill
06

What researchers measure

Primary outcomes

  1. ApoB transport rate

    Time frame: 5 weeks

Secondary outcomes

  1. ApoA and C-III transport rate

    Time frame: 5 weeks

07

Study locations

1 site
  • University of Western Australia
    Perth, Western Australia 6000, Australia
08

References and documents

Publications

  • Ooi EM, Watts GF, Sprecher DL, Chan DC, Barrett PH. Mechanism of action of a peroxisome proliferator-activated receptor (PPAR)-delta agonist on lipoprotein metabolism in dyslipidemic subjects with central obesity. J Clin Endocrinol Metab. 2011 Oct;96(10):E1568-76. doi: 10.1210/jc.2011-1131. Epub 2011 Aug 3. PubMed 21816786 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00841217
Lead sponsor
The University of Western Australia
Collaborators
National Heart Foundation, Australia
First posted
Feb 11, 2009
Start date
Apr 2003
Primary completion
Aug 2005
Completion
Dec 2008
Last update
Feb 11, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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