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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW869682 1000 mg thrice daily (TID) | Experimental | Subjects will be randomized to receive GW869682 1000 mg TID |
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| GSK189075 250 mg TID | Experimental | Subjects will be randomized to receive GSK189075 250 mg TID |
|
| GW869682-Placebo TID | Placebo Comparator | Subjects will be randomized to receive Placebo matching GW869682 for TID |
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| GSK189075-Placebo TID | Placebo Comparator | Subjects will be randomized to receive Placebo matching GSK189075 for TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW869682 | Drug | GW869682 tablet with a dose strength of 250 mg will be available for subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies. | Measurements at week 8 will be compared to measurements from Day -1 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (caloric losses body weight, body composition, weight and hip circumference.) | throughout study (Days 1-56) | |
| Leptin levels in serum | at several points during study | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | Cambridgeshire | CB2 2GG | United Kingdom |
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| Label | URL |
|---|---|
| Results for study KGW108201 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| GSK189075 | Drug | GSK189075 tablet with a dose strength of 250 mg will be available for subjects |
|
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| GSK189075-Placebo | Drug | Placebo tablets to match GSK189075 250 mg will be available for subjects |
|
| GW869682-Placebo | Drug | Placebo tablets to match GW869682 250 mg will be available for subjects |
|
| Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax) |
| Day 42 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |