ObesityPhase 2NCT00297180
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
A Phase 2 study testing GW869682 in people with Obesity, run by GlaxoSmithKline at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- GW869682
- How many people
- 136 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Baton Rouge, Louisiana, 70808
GSK Investigational Site
Daytona Beach, Florida, 32114
GSK Investigational Site
Portland, Oregon, 97239
About this study
Official 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
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.
- Conditions
- Obesity
- Being tested
- GW869682
- Keywords
- hunger, obesity, sodium-dependent glucose transporter, GW869682, body composition, SGLT2 inhibitor, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW869682Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline to Week 12.
Measured: from baseline to Week 12.
Secondary outcomes (1)
Blood levels of GW869682 at the Week 2 and Week 11.
Measured: at the Week 2 and Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297180
- Sponsor's protocol ID
- KGO105858
- Status last verified
- Apr 2015
- First submitted
- 24 Feb 2006
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00297180
- Acronym / sponsor ID
- KGO105858
- Conditions
- Obesity
- Keywords
- hunger, obesity, sodium-dependent glucose transporter, GW869682, body composition, SGLT2 inhibitor, weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW869682 | Drug | – |
Primary outcome
Percentage change in body weight from baseline to Week 12.
Time frame: from baseline to Week 12.
1 secondary outcome
Blood levels of GW869682 at the Week 2 and Week 11.
Time frame: at the Week 2 and Week 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW869682 in people with Obesity, run by GlaxoSmithKline at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline to Week 12. (time frame: from baseline to Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.