Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

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