Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
August 4, 2017 updated by: GlaxoSmithKline
An Exploratory Study to Evaluate Weight Loss, Body Composition Changes, Food Intake and Urine Glucose Excretion in Healthy Obese Subjects Over 8 Weeks of Dosing With GSK189075, GW869682 Versus Placebo
The drugs GSK189075 and GW869682 result in increased caloric losses.
This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body.
The body composition (fat,water, lean mass) is determined using a new investigational MR technology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- BMI of 30 - 40kg/m
- Females may be included if they are surgically sterile or post-menopausal
Exclusion criteria:
- Change in body weight >4% in the last 3 months
- History of eating disorders
- had bariatric surgical intervention for obesity
- have type I or II diabetes
- Thyroid disorder not under control
- Renal or hepatobiliary disease
- Excessive alcohol consumption
- Use of drugs of abuse
- donated of blood in the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GW869682 1000 mg thrice daily (TID)
Subjects will be randomized to receive GW869682 1000 mg TID
|
GW869682 tablet with a dose strength of 250 mg will be available for subjects
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
Other Names:
Placebo tablets to match GSK189075 250 mg will be available for subjects
Placebo tablets to match GW869682 250 mg will be available for subjects
|
|
Experimental: GSK189075 250 mg TID
Subjects will be randomized to receive GSK189075 250 mg TID
|
GW869682 tablet with a dose strength of 250 mg will be available for subjects
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
Other Names:
Placebo tablets to match GSK189075 250 mg will be available for subjects
Placebo tablets to match GW869682 250 mg will be available for subjects
|
|
Placebo Comparator: GW869682-Placebo TID
Subjects will be randomized to receive Placebo matching GW869682 for TID
|
GW869682 tablet with a dose strength of 250 mg will be available for subjects
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
Other Names:
Placebo tablets to match GSK189075 250 mg will be available for subjects
Placebo tablets to match GW869682 250 mg will be available for subjects
|
|
Placebo Comparator: GSK189075-Placebo TID
Subjects will be randomized to receive Placebo matching GSK189075 for TID
|
GW869682 tablet with a dose strength of 250 mg will be available for subjects
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
Other Names:
Placebo tablets to match GSK189075 250 mg will be available for subjects
Placebo tablets to match GW869682 250 mg will be available for subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies.
Time Frame: Measurements at week 8 will be compared to measurements from Day -1
|
Measurements at week 8 will be compared to measurements from Day -1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety (caloric losses body weight, body composition, weight and hip circumference.)
Time Frame: throughout study (Days 1-56)
|
throughout study (Days 1-56)
|
|
Leptin levels in serum
Time Frame: at several points during study
|
at several points during study
|
|
Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)
Time Frame: Day 42
|
Day 42
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2006
Primary Completion (Actual)
June 7, 2007
Study Completion (Actual)
June 7, 2007
Study Registration Dates
First Submitted
October 31, 2006
First Submitted That Met QC Criteria
June 28, 2007
First Posted (Estimate)
July 2, 2007
Study Record Updates
Last Update Posted (Actual)
August 7, 2017
Last Update Submitted That Met QC Criteria
August 4, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KGW108201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.