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OpenTrials
Completed

NCT Number: NCT00554216

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VI-0521

Drug

3.75 mg phentermine/23 mg topiramate

Placebo matched phentermine/topiramate

Drug

Placebo matched phentermine/topiramate

Primary outcomes

  1. Percent Weight Loss From Baseline to Week 56

    Time frame: baseline to 56 weeks

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

    Time frame: baseline to 56 weeks

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2007
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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