NCT00494767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2006

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2007

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

October 31, 2006

Last Update Submit

August 4, 2017

Conditions

Diabetes Mellitus, Type 2Obesity

Keywords

body compositionobesity4C modelhungerweight loss

Outcome Measures

Primary Outcomes (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 Outcomes (3)

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

    throughout study (Days 1-56)

  • Leptin levels in serum

    at several points during study

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

    Day 42

Study Arms (4)

GW869682 1000 mg thrice daily (TID)

EXPERIMENTAL

Subjects will be randomized to receive GW869682 1000 mg TID

Drug: GW869682Drug: GSK189075Drug: GSK189075-PlaceboDrug: GW869682-Placebo

GSK189075 250 mg TID

EXPERIMENTAL

Subjects will be randomized to receive GSK189075 250 mg TID

Drug: GW869682Drug: GSK189075Drug: GSK189075-PlaceboDrug: GW869682-Placebo

GW869682-Placebo TID

PLACEBO COMPARATOR

Subjects will be randomized to receive Placebo matching GW869682 for TID

Drug: GW869682Drug: GSK189075Drug: GSK189075-PlaceboDrug: GW869682-Placebo

GSK189075-Placebo TID

PLACEBO COMPARATOR

Subjects will be randomized to receive Placebo matching GSK189075 for TID

Drug: GW869682Drug: GSK189075Drug: GSK189075-PlaceboDrug: GW869682-Placebo

Interventions

GW869682DRUG

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

GSK189075 250 mg TIDGSK189075-Placebo TIDGW869682 1000 mg thrice daily (TID)GW869682-Placebo TID
GSK189075DRUG

GSK189075 tablet with a dose strength of 250 mg will be available for subjects

Also known as: GW869682
GSK189075 250 mg TIDGSK189075-Placebo TIDGW869682 1000 mg thrice daily (TID)GW869682-Placebo TID
GSK189075-PlaceboDRUG

Placebo tablets to match GSK189075 250 mg will be available for subjects

GSK189075 250 mg TIDGSK189075-Placebo TIDGW869682 1000 mg thrice daily (TID)GW869682-Placebo TID
GW869682-PlaceboDRUG

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

GSK189075 250 mg TIDGSK189075-Placebo TIDGW869682 1000 mg thrice daily (TID)GW869682-Placebo TID

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 30 - 40kg/m
  • Females may be included if they are surgically sterile or post-menopausal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 2GG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityWeight Loss

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2006

First Posted

July 2, 2007

Study Start

September 29, 2006

Primary Completion

June 7, 2007

Study Completion

June 7, 2007

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

GB(1)