NCT00554216

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,267

participants targeted

Target at P75+ for phase_3 obesity

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 6, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

November 3, 2007

Results QC Date

July 31, 2012

Last Update Submit

September 5, 2012

Conditions

Obesity

Keywords

Obesity, morbid obesity

Outcome Measures

Primary Outcomes (2)

  • Percent Weight Loss From Baseline to Week 56

    baseline to 56 weeks

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

    baseline to 56 weeks

Study Arms (3)

VI-0521 Low

EXPERIMENTAL

VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)

Drug: VI-0521

VI-0521 Top

EXPERIMENTAL

Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.

Drug: VI-0521

Placebo

PLACEBO COMPARATOR

Placebo to match

Drug: Placebo matched phentermine/topiramate

Interventions

VI-0521DRUG

3.75 mg phentermine/23 mg topiramate

VI-0521 Low
Placebo matched phentermine/topiramateDRUG

Placebo matched phentermine/topiramate

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) ≥ 35 kg/m2
  • Informed consent
  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

San Diego, California, 92130, United States

Location

Research

Ridgefield, Connecticut, 06877, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Toledo, Ohio, 43623, United States

Location

Research Site

Austin, Texas, 78731, United States

Location

Related Publications (1)

  • Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.

    PMID: 28455281DERIVED

MeSH Terms

Conditions

ObesityObesity, Morbid

Interventions

Topiramate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Results Point of Contact

Title
Wesley W. Day PhD
Organization
Vivus, Inc.
day@vivus.com
650-934-5200

Study Officials

  • Craig Peterson

    VIVUS LLC

    STUDY DIRECTOR

  • Kishore Gadde, MD

    Duke University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 10, 2012

Results First Posted

September 6, 2012

Record last verified: 2012-09

Locations

US(5)