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Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00494767
First received: October 31, 2006
Last updated: December 23, 2008
Last verified: December 2008
History of Changes

October 31, 2006
December 23, 2008
September 2006
Not Provided
Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies. [ Time Frame: Measurements at week 8 will be compared to measurements from Day -1 ]
Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies. Measurements at week 8 will be compared to measurements from Day -1 [ Time Frame: at week 8 will be compared to measurements from Day -1 ]
Complete list of historical versions of study NCT00494767 on ClinicalTrials.gov Archive Site
  • Safety (caloric losses body weight, body composition, weight and hip circumference.) [ Time Frame: throughout study (Days 1-56) ]
  • Leptin levels in serum [ Time Frame: at several points during study ]
  • Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax) [ Time Frame: Day 42 ]
  • Safety (throughout study) Days 1-56; (caloric losses body weight, body composition, weight and hip circumference.) [ Time Frame: (throughout study) Days 1-56; ]
  • Leptin levels in serum at several points during study [ Time Frame: at several points during study ]
  • Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax) [ Time Frame: over time (Day 42 PK parameters are AUC, Cmax, tmax) ]
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Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
An Exploratory Study to Evaluate Weight Loss, Body Composition Changes, Food Intake and Urine Glucose Excretion in Healthy Obese Subjects Over 8 Weeks of Dosing With GSK189075, GW869682 Versus Placebo

The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Obesity
  • Drug: GW869682
  • Drug: GSK189075
    Other Names:
    • GW869682
    • GSK189075
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
Not Provided

Inclusion criteria:

  • BMI of 30 - 40kg/m
  • Females may be included if they are surgically sterile or post-menopausal

Exclusion criteria:

  • Change in body weight >4% in the last 3 months
  • History of eating disorders
  • had bariatric surgical intervention for obesity
  • have type I or II diabetes
  • Thyroid disorder not under control
  • Renal or hepatobiliary disease
  • Excessive alcohol consumption
  • Use of drugs of abuse
  • donated of blood in the last 3 months
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00494767
KGW108201
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP