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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
  Purpose

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.


Condition Intervention Phase
Obesity
 Drug: GW869682
Drug: GSK189075
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2006
Intervention Details:
    Drug: GW869682 Drug: GSK189075
    Other Names:
    • GW869682
    • GSK189075
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494767

Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00494767     History of Changes
Other Study ID Numbers: KGW108201
Study First Received: October 31, 2006
Last Updated: December 23, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
weight loss
obesity
body composition
hunger
4C model

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013