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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00494767
Collaborator
(none)
27
Enrollment
1
Location
4
Arms
8.2
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 29, 2006
Actual Primary Completion Date :
Jun 7, 2007
Actual Study Completion Date :
Jun 7, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: GW869682 1000 mg thrice daily (TID)

Subjects will be randomized to receive GW869682 1000 mg TID

Drug: GW869682
GW869682 tablet with a dose strength of 250 mg will be available for subjects

Drug: GSK189075
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
Other Names:
  • GW869682

    • Drug: GSK189075-Placebo
    Placebo tablets to match GSK189075 250 mg will be available for subjects

    Drug: GW869682-Placebo
    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

    Drug: GW869682
    GW869682 tablet with a dose strength of 250 mg will be available for subjects

    Drug: GSK189075
    GSK189075 tablet with a dose strength of 250 mg will be available for subjects
    Other Names:
  • GW869682

    • Drug: GSK189075-Placebo
    Placebo tablets to match GSK189075 250 mg will be available for subjects

    Drug: GW869682-Placebo
    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

    Drug: GW869682
    GW869682 tablet with a dose strength of 250 mg will be available for subjects

    Drug: GSK189075
    GSK189075 tablet with a dose strength of 250 mg will be available for subjects
    Other Names:
  • GW869682

    • Drug: GSK189075-Placebo
    Placebo tablets to match GSK189075 250 mg will be available for subjects

    Drug: GW869682-Placebo
    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

    Drug: GW869682
    GW869682 tablet with a dose strength of 250 mg will be available for subjects

    Drug: GSK189075
    GSK189075 tablet with a dose strength of 250 mg will be available for subjects
    Other Names:
  • GW869682

    • Drug: GSK189075-Placebo
    Placebo tablets to match GSK189075 250 mg will be available for subjects

    Drug: GW869682-Placebo
    Placebo tablets to match GW869682 250 mg will be available for subjects

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Safety (caloric losses body weight, body composition, weight and hip circumference.) [throughout study (Days 1-56)]

    2. Leptin levels in serum [at several points during study]

    3. Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax) [Day 42]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Cambridge Cambridgeshire United Kingdom CB2 2GG

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00494767
    Other Study ID Numbers:
    • KGW108201
    First Posted:
    Jul 2, 2007
    Last Update Posted:
    Aug 7, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by GlaxoSmithKline
    body composition
    obesity
    4C model
    hunger
    weight loss
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Weight Loss

    Study Results

    No Results Posted as of Aug 7, 2017