Official Title: “A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: VI-0521
  • 3.75 mg phentermine/23 mg topiramate CR
• Drug: VI-0521
  • 15 mg phentermine/92 mg topiramate CR
• Drug: Placebo matched phentermine/topiramate CR
  • Placebo matched phentermine/topiramate CR

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • VI-0521; low dose phentermine/topiramate CR
• Experimental: 2
  • VI-0521; high dose phentermine/topiramate CR
• Placebo Comparator: 3
  • Placebo to match

Primary Measures

• Demonstrate an improvement over placebo in mean percent loss of baseline body weight, and percent of subjects with at least a 5% weight loss.
  • Time Frame: 56 weeks
    Safety Issue?: No

Secondary Measures

• Demonstrate improvements in obesity-associated comorbidities
  • Time Frame: 56 weeks
    Safety Issue?: No
• Demonstrate an improvement over placebo in absolute weight loss and reduction in waist circumference
  • Time Frame: 56 weeks
    Safety Issue?: No
• Demonstrate an improvement in quality of life
  • Time Frame: 56 weeks
    Safety Issue?: No

Inclusion Criteria:

• BMI ≥ 35
• 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/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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: VIVUS, Inc.

Overall Clinical Trial Officials and Contacts

Craig Peterson Study Director VIVUS, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00554216

Study ID Number: VIVUS OB-302

ClinicalTrials.gov Identifier: NCT00554216

Health Authority: United States: Food and Drug Administration