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 Adults With Obesity-Related Co-Morbid Conditions”

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Study Type: Interventional

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

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: VI-0521
  • phentermine 15 mg and topiramate 92 mg, po once daily
• Drug: VI-0521
  • phentermine 7.5 mg and topiramate 46 mg, po once daily
• Drug: VI-0521
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • high dose experimental treatment
• Experimental: 2
  • low dose experimental treatment
• Placebo Comparator: 3
  • Placebo

Primary Measures

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

Secondary Measures

• Demonstrate improvements in HgbA1c and other 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:

• 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

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/NCT00553787

Study ID Number: VIVUS OB-303

ClinicalTrials.gov Identifier: NCT00553787

Health Authority: United States: Food and Drug Administration