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CompletedNCT00297180Updated Apr 15, 2015

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

A Phase 2 interventional study of GW869682 in Obesity, sponsored by GlaxoSmithKline. Completed at 3 sites in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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Keywords

  • hunger
  • obesity
  • sodium-dependent glucose transporter
  • GW869682
  • body composition
  • SGLT2 inhibitor
  • weight loss
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 136 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
136 participants (actual)

Interventions

  • DrugGW869682
06

What researchers measure

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

07

Study locations

3 sites
  • GSK Investigational Site
    Daytona Beach, Florida 32114, United States
  • GSK Investigational Site
    Baton Rouge, Louisiana 70808, United States
  • GSK Investigational Site
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00297180
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 28, 2006
Start date
Jan 2006
Primary completion
Sep 2006
Completion
Sep 2006
Last update
Apr 15, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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