- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00297180
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
April 14, 2015 updated by: GlaxoSmithKline
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Daytona Beach, Florida, United States, 32114
- GSK Investigational Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- GSK Investigational Site
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Oregon
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Portland, Oregon, United States, 97239
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage change in body weight from baseline to Week 12.
Time Frame: from baseline to Week 12.
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from baseline to Week 12.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood levels of GW869682 at the Week 2 and Week 11.
Time Frame: at the Week 2 and Week 11
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at the Week 2 and Week 11
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
February 24, 2006
First Submitted That Met QC Criteria
February 24, 2006
First Posted (Estimate)
February 28, 2006
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 14, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KGO105858
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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