Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

Inclusion Criteria: * Read and signed the informed consent form after the nature of the study has been fully explained * 18 to 75 years og age at enrollment * subjects must have either: 1. A body mass index BMI ≥ 33 kg/m\*m and \< 50 kg/m\*m, or 2. A BMI ≥ 30 kg/m\*m \< 50 kg/m\*m if any of the following established co-morbidities are present: Controlled hypertension or dyslipidemia. Anti-hypertensive and hypo-lipidemic medication should have been at a stable dose for at least two months prior to enrollment. If subjects are clinically diagnosed with any of these conditions as a result of enrollment assessments, they can only continue in the enrollment phase if in the clinical judgment of the investigator initiation of anti-hypertensive or hypo-lipidemic therapy is not required. * Subjects diagnosed with type 2 diabetes by means of OGTT at enrollment visit and not requiring anti diabetic therapy according to the clinical judgement of the investigator. * Stable weight (varying to more than 3 kg) for at least 3 months prior to enrollment. * Female subjects must be post menopausal for at least a year or surgically incapable of childbearing, practicing abstinence an acceptable method of birth control. If a female subject of child bearing potential is practicing an acceptable method of birth control, she must have had a negative urine pregnancy test at enrollment, as well as at baseline, prior to receiving study drug. Randomization criteria 1. Weight reduction of≥ 8% of enrollment body weight at the randomization visit; 2. Subjects must have either: 2a) A BMI ≥ 30 kg/m\*m and \< 50 kg/m\*m, or 2b) A BMI ≥ 27 kg/m\*m and \< 50 kg/m\*m if any of the following established co-morbidities are present: controlled hypertension or dyslipidemia. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participating in the study. * Prior exposure or known contraindication or hypersensitivity to topiramate; * Exposure to any other experimental drug or device within 30 days prior to enrollment; * Pregnancy or nursing or subjects who plan to become pregnant during the study; * An established diagnosis of diabetes prior to study enrollment; * History or evidence of clinically significant hepatic disease; * Evidence of renal impairment; * Significant cardiovascular disease; * Uncontrolled hypertension 180 / 100 mmHg * Hypertensive subjects on medications must have been on the same dose of the same hypertensive medication for at least 2 months; * Uncontrolled thyroid disease including hyper- or hypothyroidism or an abnormal TSH-level; * A history of obesity with a known cause e.g. Cushings disease; * A history or family history (first degree relatives) of kidney stones; * Previous gastric restrictive surgery or other surgical procedures to cause weight loss, including liposuction; * History of gluten or non-gluten induced enteropathy; * Clinically significant lactose intolerance, in the opinion of the investigator; * Malignancy or with a history of malignancy within 5 years prior to enrollment, other than basal cell carcinomas of the skin; * History og seizures or significant CNS disorders; * History of significant psychiatric disorders including schizophrenia, psychosis and major affective disorders; * History of anorexia nervosa, bulimia og binge eating disorder; * A significant change in smoking habit within 2 months of the enrollment visit, in the opinion of the investigator; * History of drug or alcohol abuse within the previous 2 years; * Positive results on any urine drug screen at enrollment; * Use of any weight loss preparations within 30 days prior to enrollment; * Use of any systemic corticosteroids within 30 days prior to enrollment; * Clinically significant hematological or immunological disorder; * Currently receiving psychotropic medications, except episodic use of certain medications; * Receiving any excluded medication, depending on episodic or chronic use; * Any significant condition that, in the opinion of the investigator, could interfere with the subjects participation or compliance in the study.