Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population

- The subject did not adequately respond (i.e., did not achieve or maintain > 5%weight loss) to an appropriate non-pharmacologic weight-reducing regimen (i.e., diet and exercise) within 3 months prior to Screening. - The subject was male or female and between 18 and 65 years of age. - The subject has nutritional obesity and BMI >= 27 kg/m2 associated with dyslipidemia or has BMI >= 30 kg/m2. - Dyslipidemia was defined as having at least one of the following three conditions: - Low-density lipoprotein (LDL)-cholesterol level of > 3.4 mmol/L (> 130 mg/dL) - total cholesterol level of > 5.2 mmol/L (> 200 mg/dL) - triglyceride level of > 1.7 mmol/L (> 150 mg/dL). 254 - If the subject was female - she must either not of childbearing potential: defined as postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), - or was of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)on contraceptives (oral or parenteral) for the 3-month period prior to Week 0, a vasectomized partner, total abstinence from sexual intercourse - If the subject was female, the results of a urine pregnancy test performed at Screening and Week 0 were negative. - If the subject was female, the subject was not breast-feeding. - The subject was judged to be in general good health based upon the results of medical history, complete physical examination and clinical laboratory tests. - The subject was not taking any over-the-counter or prescription drugs, or herbal products for weight loss during the 4 week period prior to Screening. - The subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to undertaking any study-specific procedures

- History or evidence according to the 1997 American Diabetic Association (ADA)26criteria of type 1 or type 2 diabetes mellitus, i.e., fasting plasma glucose level >= 7.0 mmol/L. - Inadequately controlled hypertension having systolic blood pressure >= 145 mmHg or diastolic blood pressure >= 90 mmHg (average of three measurements) or any hypertensive subjects taking > 3 medications to control blood pressure. - History of Gilles de la Tourette's Syndrome. - Use within 4 weeks prior to Week 0 of any of the following: - Monoamine oxidase inhibitors (MAOIs): used to treat depression and Parkinson's disease. - Medications that regulate the neurotransmitter serotonin in the brain (SSRIs): used to treat psychiatric disorders and to stop smoking. - Amino acids: used to treat sleep disorders. - Certain antimigraine drugs (such as sumatriptan, dihydroergotamine). - Opioids (such as pentazocine, pethidine, fentanyl, dextromethorphan). - Organic causes of obesity (e.g., hypothyroidism). - History of major eating disorders, such as anorexia nervosa or bulimia nervosa. - History of benign prostatic hyperplasia with urinary retention. - History of neurological disorders such as seizures. - History of documented psychiatric illnesses such as anxiety, depression, bipolar disorder or schizophrenia or having psychotic symptoms. - History or evidence of severe renal or hepatic impairments. - History of narrow-angle glaucoma. - History of coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (transient ischemic attacks or strokes).13. History or evidence of hyperthyroidism. - Persistent tachycardia at rest, i.e., heart rate >100 bpm (average of 3 measurements). - History of primary or secondary pulmonary hypertension. - Underlying or suspected phaeochromocytoma. - Known hypersensitivity to sibutramine hydrochloride monohydrate or any other component of the product. - Known history of drug or alcohol abuse. - Has previous history with the use of sibutramine. - Any other medical illnesses judged by the investigator that may compromise the efficacy or safety of sibutramine. - Unlikely to cooperate in the study