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

NCT ID: NCT00297180

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW869682

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Daytona Beach, Florida, United States

Site Status

GSK Investigational Site

Baton Rouge, Louisiana, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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KGO105858

Identifier Type: -

Identifier Source: org_study_id

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