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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494767
• Other study ID #: KGW108201
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2006
• Last updated: August 4, 2017
• Start date: September 29, 2006
• Est. completion date: June 7, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 7, 2007
• Est. primary completion date: June 7, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Weight Loss

Intervention

Drug:
• GW869682
GW869682 tablet with a dose strength of 250 mg will be available for subjects
• GSK189075
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
• GSK189075-Placebo
Placebo tablets to match GSK189075 250 mg will be available for subjects
• GW869682-Placebo
Placebo tablets to match GW869682 250 mg will be available for subjects

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Safety (caloric losses body weight, body composition, weight and hip circumference.)		throughout study (Days 1-56)
Secondary	Leptin levels in serum		at several points during study
Secondary	Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)		Day 42

External Links

•   Results for study KGW108201 can be found on the GSK Clinical Study Register.