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

September 5, 2012 updated by: VIVUS LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1267

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92130
        • Research Site
    • Connecticut
      • Ridgefield, Connecticut, United States, 06877
        • Research
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Weight Loss From Baseline to Week 56
Time Frame: baseline to 56 weeks
baseline to 56 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 56
Time Frame: baseline to 56 weeks
baseline to 56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Collaborators

Medpace, Inc.

Investigators

  • Study Chair: Kishore Gadde, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 3, 2007

First Submitted That Met QC Criteria

November 3, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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