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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297180
• Other study ID #: KGO105858
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2006
• Last updated: April 14, 2015
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• GW869682

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Daytona Beach	Florida
United States	GSK Investigational Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in body weight from baseline to Week 12.		from baseline to Week 12.
Secondary	Blood levels of GW869682 at the Week 2 and Week 11.		at the Week 2 and Week 11