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OpenTrials
Completed

NCT Number: NCT00494767

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 2GG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW869682

Drug

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

GSK189075

Drug

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

Other names: GW869682

GSK189075-Placebo

Drug

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

GW869682-Placebo

Drug

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: throughout study (Days 1-56)

  2. Leptin levels in serum

    Time frame: at several points during study

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

    Time frame: Day 42

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 2, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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