Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Drug: GW869682; Drug: GSK189075; Drug: GSK189075-Placebo; Drug: GW869682-Placebo

• Registration Number: NCT00494767
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Study First Submitted: 2006-10-31
• Primary Completion: 2007-06-07
• Study Completion: 2007-06-07
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-07-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GW869682-Placebo TID	GW869682	Subjects will be randomized to receive Placebo matching GW869682 for TID
GW869682 1000 mg thrice daily (TID)	GSK189075-Placebo	Subjects will be randomized to receive GW869682 1000 mg TID
GSK189075-Placebo TID	GW869682	Subjects will be randomized to receive Placebo matching GSK189075 for TID
GW869682-Placebo TID	GSK189075	Subjects will be randomized to receive Placebo matching GW869682 for TID
GW869682-Placebo TID	GW869682-Placebo	Subjects will be randomized to receive Placebo matching GW869682 for TID
GSK189075 250 mg TID	GW869682-Placebo	Subjects will be randomized to receive GSK189075 250 mg TID
GW869682 1000 mg thrice daily (TID)	GW869682-Placebo	Subjects will be randomized to receive GW869682 1000 mg TID
GSK189075 250 mg TID	GSK189075	Subjects will be randomized to receive GSK189075 250 mg TID
GSK189075 250 mg TID	GSK189075-Placebo	Subjects will be randomized to receive GSK189075 250 mg TID
GSK189075-Placebo TID	GSK189075	Subjects will be randomized to receive Placebo matching GSK189075 for TID
GW869682-Placebo TID	GSK189075-Placebo	Subjects will be randomized to receive Placebo matching GW869682 for TID
GSK189075-Placebo TID	GW869682-Placebo	Subjects will be randomized to receive Placebo matching GSK189075 for TID
GSK189075-Placebo TID	GSK189075-Placebo	Subjects will be randomized to receive Placebo matching GSK189075 for TID
GW869682 1000 mg thrice daily (TID)	GW869682	Subjects will be randomized to receive GW869682 1000 mg TID
GSK189075 250 mg TID	GW869682	Subjects will be randomized to receive GSK189075 250 mg TID
GW869682 1000 mg thrice daily (TID)	GSK189075	Subjects will be randomized to receive GW869682 1000 mg TID

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)	Day 42

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom