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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: VI-0521; Drug: Placebo matched phentermine/topiramate

• Registration Number: NCT00554216
• Lead Sponsor: VIVUS LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-03
• Study First Submitted QC: 2007-11-03
• Study First Posted: 2007-11-06
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Results First Posted: 2012-09-06
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1267

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VI-0521 Low	VI-0521	VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)
Placebo	Placebo matched phentermine/topiramate	Placebo to match
VI-0521 Top	VI-0521	Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.

Primary Outcome Measures

Name	Time	Method
Percent Weight Loss From Baseline to Week 56	baseline to 56 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 56	baseline to 56 weeks

Trial Locations

Locations (2)

Research; 🇺🇸 Ridgefield, Connecticut, United States

Research Site; 🇺🇸 Austin, Texas, United States