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.
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 Currently taking or withdrawn during the past 6 months any drugs with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.
