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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: GW869682; Drug: GSK189075; Drug: GW869682-Placebo; Drug: GSK189075-Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494767

KGW108201

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

27 participants in 4 patient groups, including a placebo group

GW869682 1000 mg thrice daily (TID)

Experimental group

Description:

Subjects will be randomized to receive GW869682 1000 mg TID

Treatment:

Drug: GW869682-Placebo

Drug: GSK189075-Placebo

Drug: GW869682

Drug: GSK189075

GSK189075 250 mg TID

Experimental group

Description:

Subjects will be randomized to receive GSK189075 250 mg TID

Treatment:

Drug: GW869682-Placebo

Drug: GSK189075-Placebo

Drug: GW869682

Drug: GSK189075

GW869682-Placebo TID

Placebo Comparator group

Description:

Subjects will be randomized to receive Placebo matching GW869682 for TID

Treatment:

Drug: GW869682-Placebo

Drug: GSK189075-Placebo

Drug: GW869682

Drug: GSK189075

GSK189075-Placebo TID

Placebo Comparator group

Description:

Subjects will be randomized to receive Placebo matching GSK189075 for TID

Treatment:

Drug: GW869682-Placebo

Drug: GSK189075-Placebo

Drug: GW869682

Drug: GSK189075