Last updated: 11/04/2018 08:32:22

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

GSK study ID
KGW108201
See study documents
Clinicaltrials.gov ID
NCT00494767
EudraCT ID
2006-003864-71
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Measurements at week 8 will be compared to measurements from Day -1

Secondary outcomes:

Safety (caloric losses body weight, body composition, weight and hip circumference.)

Timeframe: throughout study (Days 1-56)

Leptin levels in serum

Timeframe: at several points during study

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

Timeframe: Day 42

Interventions:
  • Drug: GW869682
  • Drug: GSK189075
  • Drug: GSK189075-Placebo
  • Drug: GW869682-Placebo
    • Enrollment:
    27
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2, Obesity
    Product
    remogliflozin etabonate, sergliflozin etabonate
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to June 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • BMI of 30 - 40kg/m
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-07-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study KGW108201 can be found on the GSK Clinical Study Register.
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    Access to clinical trial data by researchers
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