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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00494767

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 I

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

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

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, Cambridgeshire
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

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

Keywords provided by GlaxoSmithKline:

weight loss
obesity
body composition
hunger
4C model

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes

Nutrition Disorders
Overweight
Overnutrition
Healthy

ClinicalTrials.gov processed this record on January 16, 2009