VI-0521 Safety and Efficacy in Adult Obesity with Related Co-Morbidities

Study start date: November 1, 2007

Inclusion Criteria: * Informed Consent * BMI ≥ 27 (no lower BMI limit for Type 2 diabetics) * 70 years of age or less * Have 2 or more of the following obesity-related co-morbid conditions: * Systolic blood pressure 140-160 mmHg (130-160 if diabetic); * Diastolic blood pressure 90-100 mmHg (85-100 if diabetic); * Requirement for 2 or more medications to achieve control (\<140/90 mmHg) * Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (\<200 mg/dL) * At lease one of the following metabolic criteria: * Fasting blood glucose level \> 100 mg/dL * Glucose level \> 140 mg/dL * Diagnosis of type 2 diabetes * Waist circumference ≥ 102 cm for men or ≥88 cm for women Exclusion Criteria: * Stroke/MI/unstable cardiovascular disease within 6 months * Clinically significant renal, hepatic or psychiatric disease * Unstable thyroid disease or replacement therapy * Nephrolithiasis * Obesity of known genetic or endocrine origin * Participation in a formal weight loss program or lifestyle intervention * Glaucoma or intraocular pressure * Pregnancy or breastfeeding * Drug or Alcohol abuse * Smoking cessation within previous 3 months or plans to quit smoking during study * Eating disorders * Cholelithiasis within past 6 months * Excluded medications * Type 1 diabetes or use of any antidiabetic medication other than metformin * Previous bariatric surgery * Bipolar disorder or psychosis * Steroid hormone therapy * Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg * Creatinine clearance \< 60 mL/minute