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

VIVUS LLC1,267 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,267

Conditions

Obesity

Interventions

VI-0521DRUG

3.75 mg phentermine/23 mg topiramate

VI-0521DRUG

15 mg phentermine/92 mg topiramate

Placebo matched phentermine/topiramateDRUG

Placebo matched phentermine/topiramate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (5)

Research Site

San Diego, California, United States

Research

Ridgefield, Connecticut, United States

Research Site

Durham, North Carolina, United States

Research Site

Toledo, Ohio, United States

Outcomes

Primary Outcomes

Percent Weight Loss From Baseline to Week 56

Time frame: baseline to 56 weeks

Percentage of Subjects With at Least 5% Weight Loss at Week 56

Time frame: baseline to 56 weeks

Data from ClinicalTrials.gov

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