Expired Study
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Baton Rouge, Louisiana 70808


Purpose:

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.


Criteria:

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 Currently taking or withdrawn during the past 6 months any drugs with significant impact on body weight (e.g. serotoninergically acting drugs, antidepressants, central adrenergically acting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.


NCT ID:

NCT00752726


Primary Contact:

Study Director
GlaxoSmithKline Clinical Trials, PharmD
GlaxoSmithKline


Backup Contact:

N/A


Location Contact:

Baton Rouge, Louisiana 70808
United States

GSK Call Center
Phone: 877-379-3718

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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