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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GW869682
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring hunger, obesity, sodium-dependent glucose transporter, GW869682, body composition, SGLT2 inhibitor, weight loss

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Percentage change in body weight from baseline to Week 12.

Secondary Outcome Measures

Blood levels of GW869682 at the Week 2 and Week 11.

Full Information

First Posted
February 24, 2006
Last Updated
April 14, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00297180
Brief Title
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
hunger, obesity, sodium-dependent glucose transporter, GW869682, body composition, SGLT2 inhibitor, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW869682
Primary Outcome Measure Information:
Title
Percentage change in body weight from baseline to Week 12.
Time Frame
from baseline to Week 12.
Secondary Outcome Measure Information:
Title
Blood levels of GW869682 at the Week 2 and Week 11.
Time Frame
at the Week 2 and Week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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