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GW869682

Phase 2

Obesity | Small molecule | Metabolic |GSK plc|Last Updated: Aug 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

GW869682 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00297180Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 WeeksObesity
COMPLETED136 Analytics
PHASE2COMPLETED
Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Blood levels of GW869682 at the Week 2 and Week 11.
at the Week 2 and Week 11
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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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GW869682 1000 mg thrice daily (TID)EXPERIMENTALSubjects will be randomized to receive GW869682 1000 mg TID
GSK189075 250 mg TIDEXPERIMENTALSubjects will be randomized to receive GSK189075 250 mg TID
GW869682-Placebo TIDPLACEBO_COMPARATORSubjects will be randomized to receive Placebo matching GW869682 for TID
GSK189075-Placebo TIDPLACEBO_COMPARATORSubjects will be randomized to receive Placebo matching GSK189075 for TID

Interventions

NameTypeDescription
GW869682DRUG -
GSK189075DRUGGSK189075 tablet with a dose strength of 250 mg will be available for subjects
GSK189075-PlaceboDRUGPlacebo tablets to match GSK189075 250 mg will be available for subjects
GW869682-PlaceboDRUGPlacebo tablets to match GW869682 250 mg will be available for subjects
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites3

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. * Recen...

Countries:United StatesUnited Kingdom
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Frequently asked questions about GW869682

What is GW869682 used for?

GW869682 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus and Obesity. It is being developed by GSK plc (GSK) and is currently in Phase 1 clinical development. The drug has been evaluated in clinical trials for weight loss in obese subjects and for weight loss and body composition changes in patients with Type 2 Diabetes and Obesity.

Who makes GW869682?

GW869682 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is an investigational small molecule in Phase 1 clinical development for metabolic conditions including Type 2 Diabetes Mellitus and Obesity.

What phase is GW869682 in?

GW869682 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed clinical trials, including a Phase 2 study for obesity and a Phase 1 study for Type 2 Diabetes Mellitus and Obesity, but it remains in early-stage development.

What clinical trials is GW869682 in?

GW869682 has been studied in two completed clinical trials. NCT00297180 was a Phase 2 study of weight loss in 136 obese subjects taking GW869682 or placebo three times daily for 12 weeks in the United States. NCT00494767 was a Phase 1 study of weight loss and body composition changes in 27 subjects with Type 2 Diabetes and Obesity in the United Kingdom.

Is GW869682 the same as any other drug?

GW869682 is a unique investigational compound and no alternative names have been reported. It is a small molecule being developed by GSK plc for metabolic conditions. The drug is distinct from other agents and is identified by its code name GW869682 in clinical trial registries.