Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIVUS, Inc.
• Collaborator: Medpace, Inc.
• Treatments: Phentermine; Topiramate

Criteria

Inclusion Criteria:

• Body mass index (BMI) ≥ 35 kg/m2

• Informed consent

• 70 years of age or less

• Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications

• Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension

• Fasting blood glucose level of ≤ 110 mg/dL

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

• History of glaucoma or intraocular pressure

• Pregnancy or breastfeeding

• 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 2 diabetes

• Previous bariatric surgery

• History of bipolar disorder or psychosis