Official Title: “The Effects of Weight Reduction With Orlistat vs. Placebo on Changes in Body Composition”

Weight loss is associated with changes in body composition. The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

• Drug: orlistat

Primary Measures

• Abdominal visceral adipose tissue (VAT) mass

Secondary Measures

• Body weight, total fat mass, liver fat (IHL), waist circumference, percent body fat, physical activity and quality of life, selectivity index, safety and tolerability

Inclusion Criteria

• 1. Aged 18-60 years inclusive
• 2. Body Mass Index (BMI): BMI in the range of 25.0-34.9 kg/m2 Approximately 1/3 of patients BMI between 25.0-27.9 kg/m2 Approximately 2/3 of patients BMI between 28.0-34.9 kg/m2
• 3. Waist circumference:
• Females: > 35 inches Males: > 40 inches
• 4)Diet
• a) Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner) b) Willing to follow a hypocaloric diet during the study to achieve weight loss c) Willing to take a daily multivitamin for the duration of the study.
• 5)General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria

• 1. Pregnancy Women who are known to be pregnant, have a positive pregnancy test, or who are intending to become pregnant over the duration of the study.
• 2. Breast-feeding Women who are breast-feeding
• 3. Diet/Exercise Currently on a special diet or who cannot fulfill the dietary requirements of the study.
• 4. Smoking History
• 1. Smoking cessation within the past 6 months
• 2. Current Smokers
• 5. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials and study foods (or closely related compounds) or any of their stated ingredients.
• 6. Medication
• 1. Currently taking medication for weight loss or appetite control.
• 2. Previous Xenical® (orlistat) or alli® use within 3 months of screening date
• 3. Currently taking medication or supplements that influence intestinal transit time and other stool formation parameters or influences cramping (e.g., Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide.
• Also, any laxative or antidiarrheal product).
• 4. Currently taking or withdrawn during the past 6 months any drugs with significant impact on body weight (e.g. serotoninergically acting drugs, antidepressants, central adrenergically acting drugs, drugs inhibiting digestion and absorption, appetite suppressants, metformin)
• 5. Currently taking Cyclosporine, Warfarin or Amiodarone HCL
• 7. Disease/Surgery
• 1. History of gastrointestinal disease (e.g., irritable bowel syndrome, diarrhea, inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence, pancreatitis).
• 2. History of psychological disorder, including eating disorders such as anorexia nervosa and bulimia
• 3. History of neurological disorder (e.g. seizures, parkinson's disease, Alzheimer's disease)
• 4. History of hypo/hyperthyroidism unless euthyroid and controlled on a stable dose of medication for at least 6 months.
• 5. History of surgery for weight loss
• 6. Uncontrolled hypertension
• 7. Heart Disease
• 8. Diabetes Mellitus (Type 1 and 2) (Fasting Blood Glucose >126 mg/dL)
• 8. Subject has a known history of panic attacks and/or claustrophobia or other conditions precluding safe EchoMRI, CT or other scanning modalities according to local guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal implants) or in the opinion of the Investigator the subject exceeds size limitations for the instruments.
• 9. Subject has had a weight loss or gain of greater than or equal to 3 kg in the 3 months prior to screening.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GlaxoSmithKline Clinical Trials, PharmD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00752726

Study ID Number: W3600586

ClinicalTrials.gov Identifier: NCT00752726

Health Authority: United States: Food and Drug Administration