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NCT Number: NCT00563368

A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases 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, Durham, North Carolina, 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

  • 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
  • Informed Consent
  • Females of child-bearing potential must be using adequate contraception

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
  • Glaucoma or elevated intraocular pressure
  • Pregnancy or breastfeeding
  • Drug or Alcohol abuse
  • Smoking cessation within previous 3 months or plans to quit smoking during study
  • Eating disorders within past year
  • Cholelithiasis within past 6 months
  • Type 2 diabetes
  • Previous bariatric surgery
  • Bipolar disorder or psychosis
  • Steroid hormone therapy not stable for 3 months
  • Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg

Treatment and study plan

VI-0521

Drug

phentermine 15 mg and topiramate 92 mg, po once daily

Topiramate

Drug

topiramate 46 mg, po once daily

Phentermine

Drug

phentermine 7.5 mg, po once daily

Primary outcomes

  1. Percent Weight Loss From Baseline to Week 28

    Time frame: baseline to 28 weeks

    Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)

  2. Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF

    Time frame: baseline to 28 weeks

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 26, 2007
Registry last updated
Mar 30, 2015

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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