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

This is an interventional treatment trial for Obesity Read More

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.