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

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GW869682
GSK189075
GSK189075-Placebo
GW869682-Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring body composition, obesity, 4C model, hunger, weight loss

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

GW869682 1000 mg thrice daily (TID)

GSK189075 250 mg TID

GW869682-Placebo TID

GSK189075-Placebo TID

Arm Description

Subjects will be randomized to receive GW869682 1000 mg TID

Subjects will be randomized to receive GSK189075 250 mg TID

Subjects will be randomized to receive Placebo matching GW869682 for TID

Subjects will be randomized to receive Placebo matching GSK189075 for TID

Outcomes

Primary Outcome Measures

Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies.

Secondary Outcome Measures

Safety (caloric losses body weight, body composition, weight and hip circumference.)
Leptin levels in serum
Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)

Full Information

First Posted
October 31, 2006
Last Updated
August 4, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00494767
Brief Title
Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 29, 2006 (Actual)
Primary Completion Date
June 7, 2007 (Actual)
Study Completion Date
June 7, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
body composition, obesity, 4C model, hunger, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GW869682 1000 mg thrice daily (TID)
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive GW869682 1000 mg TID
Arm Title
GSK189075 250 mg TID
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive GSK189075 250 mg TID
Arm Title
GW869682-Placebo TID
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive Placebo matching GW869682 for TID
Arm Title
GSK189075-Placebo TID
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive Placebo matching GSK189075 for TID
Intervention Type
Drug
Intervention Name(s)
GW869682
Intervention Description
GW869682 tablet with a dose strength of 250 mg will be available for subjects
Intervention Type
Drug
Intervention Name(s)
GSK189075
Other Intervention Name(s)
GW869682
Intervention Description
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
Intervention Type
Drug
Intervention Name(s)
GSK189075-Placebo
Intervention Description
Placebo tablets to match GSK189075 250 mg will be available for subjects
Intervention Type
Drug
Intervention Name(s)
GW869682-Placebo
Intervention Description
Placebo tablets to match GW869682 250 mg will be available for subjects
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Safety (caloric losses body weight, body composition, weight and hip circumference.)
Time Frame
throughout study (Days 1-56)
Title
Leptin levels in serum
Time Frame
at several points during study
Title
Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)
Time Frame
Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2GG
Country
United Kingdom

12. IPD Sharing Statement

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

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