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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00494767
First received: October 31, 2006
Last updated: August 4, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2 Obesity Drug: GW869682 Drug: GSK189075 Drug: GSK189075-Placebo Drug: GW869682-Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Measures:
  • Safety (caloric losses body weight, body composition, weight and hip circumference.) [ Time Frame: throughout study (Days 1-56) ]
  • Leptin levels in serum [ Time Frame: at several points during study ]
  • Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax) [ Time Frame: Day 42 ]

Enrollment: 27
Actual Study Start Date: September 29, 2006
Study Completion Date: June 7, 2007
Primary Completion Date: June 7, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494767

Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00494767     History of Changes
Other Study ID Numbers: KGW108201
Study First Received: October 31, 2006
Last Updated: August 4, 2017

Keywords provided by GlaxoSmithKline:
body composition
obesity
4C model
hunger
weight loss

Additional relevant MeSH terms:
Diabetes Mellitus
Weight Loss
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017