Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
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
1 other identifier
interventional
136
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Jan 2006
Shorter than P25 for phase_2 obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedApril 15, 2015
April 1, 2015
8 months
February 24, 2006
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change in body weight from baseline to Week 12.
from baseline to Week 12.
Secondary Outcomes (1)
Blood levels of GW869682 at the Week 2 and Week 11.
at the Week 2 and Week 11
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70808, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
January 1, 2006
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
April 15, 2015
Record last verified: 2015-04