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OpenTrials
Completed

NCT Number: NCT00297180

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW869682

Drug

Primary outcomes

  1. Percentage change in body weight from baseline to Week 12.

    Time frame: from baseline to Week 12.

Secondary outcomes

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

    Time frame: at the Week 2 and Week 11

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 28, 2006
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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