Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

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 Adults With Obesity-Related Co-Morbid Conditions

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2487

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • Connecticut
      • Ridgefield, Connecticut, United States, 06877
        • Research Site
    • New York
      • New York, New York, United States, 10025
        • Research Site
    • 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:

  • Informed Consent
  • BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
  • 70 years of age or less

  • Have 2 or more of the following obesity-related co-morbid conditions:

    • Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
    • Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
    • Requirement for 2 or more medications to achieve control (<140/90 mmHg)
  • Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)

  • At lease one of the following metabolic criteria:

    • Fasting blood glucose level > 100 mg/dL
    • Glucose level > 140 mg/dL
    • Diagnosis of type 2 diabetes
  • Waist circumference ≥ 102 cm for men or ≥88 cm for women

Exclusion Criteria:

  • Stroke/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 intraocular pressure
  • Pregnancy or breastfeeding
  • Drug or 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 1 diabetes or use of any antidiabetic medication other than metformin
  • Previous bariatric surgery
  • Bipolar disorder or psychosis
  • Steroid hormone therapy
  • Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
  • Creatinine clearance < 60 mL/minute

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Drug: VI-0521
placebo
Experimental: VI-0521 Top
high dose experimental treatment
Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Drug: VI-0521
placebo
Experimental: VI-0521 Mid
mid dose experimental treatment
Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Drug: VI-0521
placebo

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 a Weight Loss of at Least 5% at Week 56 With LOCF
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)

June 1, 2009

Study Completion (Actual)

June 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-303

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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