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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
  • BMI of 30 - 40kg/m
  • Females may be included if they are surgically sterile or post-menopausal
  • Change in body weight >4% in the last 3 months
  • History of eating disorders
Inclusion and exclusion 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
Completed
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

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Additional information
Results for study KGW108201 can be found on the GSK Clinical Study Register.
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