ObesityPhase 3NCT00563368

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

A Phase 3 study testing VI-0521, topiramate and phentermine in people with Obesity, run by VIVUS LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obesity
What is being tested?: VI-0521, topiramate and phentermine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 756 participants
Where: 2 sitesUnited States
Study dates: Dec 2007to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Durham, North Carolina
Research Site
Philadelphia, Pennsylvania

Other trials in United States

About this study

Official 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

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.

Conditions: Obesity
Being tested: VI-0521, topiramate, phentermine
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VI-0521Drug
phentermine 15 mg and topiramate 92 mg, po once daily
VI-0521Drug
phentermine 7.5 mg and topiramate 46 mg, po once daily
topiramateDrug
topiramate 46 mg, po once daily
topiramateDrug
topiramate 92 mg, po once daily
phentermineDrug
phentermine 7.5 mg, po once daily
phentermineDrug
phentermine 15 mg, po once daily
VI-0521Drug
placebo, po once daily

Study groups in NCT00563368
Study group	Role	What they receive
VI-0521 Top	Experimental	VI-0521; high dose phentermine/topiramate Receives: Drug: VI-0521
VI-0521 Mid	Experimental	VI-0521; mid dose phentermine/topiramate Receives: Drug: VI-0521
TPM 46	Active comparator	mid dose topiramate Receives: Drug: topiramate
TPM 92	Active comparator	high dose topiramate Receives: Drug: topiramate
PHEN 7.5	Active comparator	mid dose phentermine Receives: Drug: phentermine
PHEN 15	Active comparator	high dose phentermine Receives: Drug: phentermine
Placebo	Placebo comparator	Not described Receives: Drug: VI-0521

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Weight Loss From Baseline to Week 28
Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)
Measured: baseline to 28 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
Measured: baseline to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Sep 2008

First posted26 Nov 2007 (estimated)
Study startDec 2007
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 756 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00563368
Sponsor's protocol ID: OB-301
Status last verified: Mar 2015
First submitted: 21 Nov 2007
Last updated: 30 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00563368
Acronym / sponsor ID: OB-301
Conditions: Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 756 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: Medpace, Inc.
Study start: Dec 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 26 Nov 2007 (estimated)
Results: Posted 3 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
VI-0521 Top	Experimental	Drug: VI-0521VI-0521; high dose phentermine/topiramate
VI-0521 Mid	Experimental	Drug: VI-0521VI-0521; mid dose phentermine/topiramate
TPM 46	Active comparator	Drug: topiramatemid dose topiramate
TPM 92	Active comparator	Drug: topiramatehigh dose topiramate
PHEN 7.5	Active comparator	Drug: phenterminemid dose phentermine
PHEN 15	Active comparator	Drug: phenterminehigh dose phentermine
Placebo	Placebo comparator	Drug: VI-0521

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VI-0521phentermine 15 mg and topiramate 92 mg, po once daily	Drug	VI-0521 Top
VI-0521phentermine 7.5 mg and topiramate 46 mg, po once daily	Drug	VI-0521 Mid
topiramatetopiramate 46 mg, po once daily	Drug	TPM 46
topiramatetopiramate 92 mg, po once daily	Drug	TPM 92
phenterminephentermine 7.5 mg, po once daily	Drug	PHEN 7.5
phenterminephentermine 15 mg, po once daily	Drug	PHEN 15
VI-0521placebo, po once daily	Drug	Placebo

Primary outcome

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)
Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
Time frame: baseline to 28 weeks

Results and safety

Results posted to the registry on 3 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	109	74
PHEN 7.5 mg	109	79
TPM 46 mg	108	78
VI-0521 Mid	107	78
PHEN 15 mg	108	80
TPM 92 mg	107	77
VI-0521 Top	108	75

Primary outcome: Percent Weight Loss From Baseline to Week 28

Time frame: baseline to 28 weeks. Least squares mean (Standard Error). Unit: percent weight loss

Measure	Placebo n = 103	PHEN 7.5 mg n = 104	TPM 46 mg n = 102	VI-0521 Mid n = 103	PHEN 15 mg n = 106	TPM 92 mg n = 105	VI-0521 Top n = 103
Value	1.7 (0.61)	5.5 (0.61)	5.1 (0.61)	8.5 (0.62)	6.1 (0.61)	6.4 (0.62)	9.2 (0.61)

TPM 92 mg vs VI-0521 Top: Mean Difference (Final Values): 2.76 (95% CI 1.13 to 4.39), p = 0.0009, ANCOVA
PHEN 15 mg vs VI-0521 Top: Mean Difference (Final Values): 3.15 (95% CI 1.53 to 4.77), p = 0.0001, ANCOVA
Placebo vs VI-0521 Top: Mean Difference (Final Values): 7.49 (95% CI 5.86 to 9.12), p <0.0001, ANCOVA

Population analysed: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)

Primary outcome: Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF

Time frame: baseline to 28 weeks. Number. Unit: percentage of participants

Measure	Placebo n = 103	PHEN 7.5 mg n = 104	TPM 46 mg n = 102	VI-0521 Mid n = 103	PHEN 15 mg n = 106	TPM 92 mg n = 105	VI-0521 Top n = 103
Value	15.5	43.3	39.2	62.1	46.2	48.6	66.0

TPM 92 mg vs VI-0521 Top: Odds Ratio (OR): 2.028 (95% CI 1.154 to 3.563), p = 0.0140, Regression, Logistic
PHEN 15 mg vs VI-0521 Top: Odds Ratio (OR): 2.246 (95% CI 1.283 to 3.932), p = 0.0046, Regression, Logistic
Placebo vs VI-0521 Top: Odds Ratio (OR): 10.623 (95% CI 5.424 to 20.81), p <0.0001, Regression, Logistic

Population analysed: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)

Adverse events

Time frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 109 (0%)	87 of 109 (79.8%)	Not reported
PHEN 7.5 mg	2 of 109 (1.8%)	85 of 109 (78%)	Not reported
TPM 46 mg	0 of 106 (0%)	90 of 106 (84.9%)	Not reported
VI-0521 Mid	1 of 106 (0.9%)	84 of 106 (79.2%)	Not reported
PHEN 15 mg	1 of 108 (0.9%)	88 of 108 (81.5%)	Not reported
TPM 92 mg	1 of 107 (0.9%)	84 of 107 (78.5%)	Not reported
VI-0521 Top	2 of 108 (1.9%)	88 of 108 (81.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig Peterson study director

VIVUS LLC

Kishore Gadde, MD study chair

Duke University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VI-0521, topiramate and phentermine in people with Obesity, run by VIVUS LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Weight Loss From Baseline to Week 28 (time frame: baseline to 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00563368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.