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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    Page 1 of 1 (3 locations)

    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