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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00297180
Enrollment
136
Registered
2006-02-28
Start date
2006-01-31
Completion date
2006-09-30
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
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

* 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.

Design outcomes

Primary

MeasureTime frame
Percentage change in body weight from baseline to Week 12.from baseline to Week 12.

Secondary

MeasureTime frame
Blood levels of GW869682 at the Week 2 and Week 11.at the Week 2 and Week 11

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026