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

GlaxoSmithKline27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Diabetes Mellitus, Type 2 Obesity

Interventions

GW869682DRUG

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

GSK189075DRUG

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

GSK189075-PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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