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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Not applicable
Primary completion date:
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
- Body Mass Index in the range of 27 - 43 kg/m2
- Waist circumference > 95cm
- Clinically relevant abnormalities on screening ECG/holter, labs or medical examination
- Use of tobacco within 6 months of the study
Inclusion and exclusion 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
GSK Investigational Site
BATON ROUGE, Louisiana, United States, 70808
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
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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