Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks

This study has been completed.

First Received: February 24, 2006 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00297180

Purpose

GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see whether enough calories from glucose are excreted in the urine to cause weight loss.

Condition	Intervention	Phase
Obesity	Drug: GW869682	Phase II

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Single Group Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Weight Loss, Safety, Tolerability and Pharmacokinetics in Obese Subjects Following 12-Week Dosing of GW869682, an SGLT2 Inhibitor

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage change in body weight from baseline to Week 12. [ Time Frame: from baseline to Week 12. ]

Secondary Outcome Measures:

Blood levels of GW869682 at the Week 2 and Week 11. [ Time Frame: at the Week 2 and Week 11 ]

Enrollment:	140
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition).

Exclusion criteria:

History of eating disorders.
Recent history of weight loss or gain.
Had gastrointestinal surgery for treatment of obesity.
Type 1 or type 2 diabetes mellitus.
Have a positive urine drug screen.
Have liver disease.
Have hepatitis B, hepatitis C, or HIV antibodies.
Have a thyroid disorder that is not under control with medication.
Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
Are unable to participate in an exercise program.
Have used weight loss drugs within 3 months before the start of the study.
Are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled & intranasal corticosteroids are permitted), or antiretroviral medications.
Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
High or low blood pressure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297180

Locations

United States, Florida
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97239

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	KGO105858
Study First Received:	February 24, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00297180 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

weight loss
obesity
body composition
hunger

GW869682
sodium-dependent glucose transporter
SGLT2 inhibitor

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 06, 2009