Last updated: 11/04/2018 10:11:39

An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation

GSK study ID
PAD100958
Clinicaltrials.gov ID
NCT00388180
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW501516
  • Drug: GW590735
    • Enrollment:
    71
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hypercholesterolemia, Dyslipidaemias
    Product
    GW501516, GW590735
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to June 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Body Mass Index in the range of 27 - 43 kg/m2
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Body Mass Index in the range of 27
    • 43 kg/m2
    • Waist circumference > 95cm Exclusion criteria:
    • 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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    BATON ROUGE, Louisiana, United States, 70808
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-22-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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