Status:
COMPLETED
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
Lead Sponsor:
GlaxoSmithKline
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00297180
Start Date
January 1 2006
End Date
September 1 2006
Last Update
April 15 2015
Active Locations (3)
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1
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
2
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
3
GSK Investigational Site
Portland, Oregon, United States, 97239