A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

Inclusion Criteria:

• 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
• Informed Consent
• Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

• Stroke/myocardial infarction (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 elevated intraocular pressure
• Pregnancy or breastfeeding
• Drug or Alcohol abuse
• Smoking cessation within previous 3 months or plans to quit smoking during study
• Eating disorders within past year
• Cholelithiasis within past 6 months
• Type 2 diabetes
• Previous bariatric surgery
• Bipolar disorder or psychosis
• Steroid hormone therapy not stable for 3 months
• Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg