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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00494767

Enrollment

Registered

2007-07-02

Start date

2006-09-29

Completion date

2007-06-07

Last updated

2017-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity

Keywords

body composition, obesity, 4C model, hunger, weight loss

Brief 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.

Interventions

DRUGGW869682

GW869682 tablet with a dose strength of 250 mg will be available for subjects

DRUGGSK189075

GSK189075 tablet with a dose strength of 250 mg will be available for subjects

DRUGGSK189075-Placebo

Placebo tablets to match GSK189075 250 mg will be available for subjects

DRUGGW869682-Placebo

Placebo tablets to match GW869682 250 mg will be available for subjects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026