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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Obesity

Treatments

Drug: GW869682

Study type

Interventional

Funder types

Industry

Identifiers

NCT00297180
KGO105858

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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