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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: October 31, 2006
Last updated: April 14, 2015
Last verified: April 2015

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
Diabetes Mellitus, Type 2
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:

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: 27
Study Start Date: September 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW869682 Drug: GSK189075
    Other Names:
    • GW869682
    • GSK189075

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

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
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Please refer to this study by its identifier: NCT00494767

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

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00494767     History of Changes
Other Study ID Numbers: KGW108201
Study First Received: October 31, 2006
Last Updated: April 14, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Weight Loss
Body Weight
Body Weight Changes
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms processed this record on October 08, 2015