Obesity
Conditions
Keywords
hunger, obesity, sodium-dependent glucose transporter, GW869682, body composition, SGLT2 inhibitor, weight loss
Brief 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.
Interventions
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline to Week 12. | from baseline to Week 12. |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of GW869682 at the Week 2 and Week 11. | at the Week 2 and Week 11 |
Countries
United States