NCT00563368

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
756

participants targeted

Target at P75+ for phase_3 obesity

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

September 3, 2012

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

November 21, 2007

Results QC Date

July 31, 2012

Last Update Submit

March 10, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Percent Weight Loss From Baseline to Week 28

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

    baseline to 28 weeks

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

    baseline to 28 weeks

Study Arms (7)

VI-0521 Top

EXPERIMENTAL

VI-0521; high dose phentermine/topiramate

Drug: VI-0521

VI-0521 Mid

EXPERIMENTAL

VI-0521; mid dose phentermine/topiramate

Drug: VI-0521

TPM 46

ACTIVE COMPARATOR

mid dose topiramate

Drug: topiramate

TPM 92

ACTIVE COMPARATOR

high dose topiramate

Drug: topiramate

PHEN 7.5

ACTIVE COMPARATOR

mid dose phentermine

Drug: phentermine

PHEN 15

ACTIVE COMPARATOR

high dose phentermine

Drug: phentermine

Placebo

PLACEBO COMPARATOR
Drug: VI-0521

Interventions

VI-0521DRUG

phentermine 15 mg and topiramate 92 mg, po once daily

VI-0521 Top
topiramateDRUG

topiramate 46 mg, po once daily

TPM 46
phentermineDRUG

phentermine 7.5 mg, po once daily

PHEN 7.5

Eligibility Criteria

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

You may qualify if:

  • 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

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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Durham, North Carolina, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

TopiramatePhentermine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetosesAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 30, 2015

Results First Posted

September 3, 2012

Record last verified: 2015-03

Locations

US(2)