ObesityPhase 3NCT00554216

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

A Phase 3 study testing VI-0521 in people with Obesity, run by VIVUS LLC at 5 sites in United States.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obesity
What is being tested?: VI-0521
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,267 participants
Where: 5 sitesUnited States
Study dates: Nov 2007to May 2009
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

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

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 16Show fewer

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Obesity
Being tested: VI-0521, Placebo matched phentermine/topiramate
Keywords: Obesity, morbid obesity
Medical subject headings: Obesity, Obesity, Morbid

What participants receive

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

VI-0521Drug
3.75 mg phentermine/23 mg topiramate
VI-0521Drug
15 mg phentermine/92 mg topiramate
Placebo matched phentermine/topiramateDrug
Placebo matched phentermine/topiramate

Study groups in NCT00554216
Study group	Role	What they receive
VI-0521 Low	Experimental	VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) Receives: Drug: VI-0521
VI-0521 Top	Experimental	Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. Receives: Drug: VI-0521
Placebo	Placebo comparator	Placebo to match Receives: Drug: Placebo matched phentermine/topiramate

What is being measured

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

Percent Weight Loss From Baseline to Week 56
Measured: baseline to 56 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 56
Measured: baseline to 56 weeks

Timeline

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

Nov 2007May 2009

First posted6 Nov 2007 (estimated)
Study startNov 2007
Primary completionMay 2009
Study completionMay 2009

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.
Publications (1)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00554216
Sponsor's protocol ID: OB-302
Status last verified: Sep 2012
First submitted: 3 Nov 2007
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 28455281

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 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00554216
Acronym / sponsor ID: OB-302
Conditions: Obesity
Keywords: Obesity, morbid obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,267 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: Medpace, Inc.
Study start: Nov 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 6 Nov 2007 (estimated)
Results: Posted 6 Sep 2012

Clinical summary

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
VI-0521 Low	Experimental	Drug: VI-0521VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)
VI-0521 Top	Experimental	Drug: VI-0521Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.
Placebo	Placebo comparator	Drug: Placebo matched phentermine/topiramatePlacebo to match

Who may qualify

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

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 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-05213.75 mg phentermine/23 mg topiramate	Drug	VI-0521 Low
VI-052115 mg phentermine/92 mg topiramate	Drug	VI-0521 Top
Placebo matched phentermine/topiramatePlacebo matched phentermine/topiramate	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 6 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	514	272
VI-0521 Low	241	147
VI-0521 Top	512	340

Primary outcome: Percent Weight Loss From Baseline to Week 56

Time frame: baseline to 56 weeks. Least squares mean (Standard Error). Unit: percent weight loss

Measure	Placebo n = 498	VI-0521 Low n = 234	VI-0521 Top n = 498
Value	1.55 (0.395)	5.10 (0.538)	10.92 (0.392)

Placebo vs VI-0521 Top: Mean Difference (Final Values): 9.36 (95% CI 8.43 to 10.30), p <0.0001, ANCOVA
Placebo vs VI-0521 Low: Mean Difference (Final Values): 3.54 (95% CI 2.38 to 4.71), p <0.0001, ANCOVA
VI-0521 Low vs VI-0521 Top: Mean Difference (Final Values): 5.82 (95% CI 4.65 to 6.99), 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 56

Time frame: baseline to 56 weeks. Number. Unit: percentage of participants

Measure	Placebo n = 498	VI-0521 Low n = 234	VI-0521 Top n = 498
Value	17.3	44.9	66.7

Placebo vs VI-0521 Top: Odds Ratio (OR): 9.61 (95% CI 7.13 to 12.95), p <0.0001, Regression, Logistic
Placebo vs VI-0521 Low: Odds Ratio (OR): 3.97 (95% CI 2.80 to 5.63), p <0.0001, Regression, Logistic
VI-0521 Low vs VI-0521 Top: Odds Ratio (OR): 2.42 (95% CI 1.76 to 3.33), 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	14 of 513 (2.7%)	374 of 513 (72.9%)	Not reported
VI-0521 Low	6 of 240 (2.5%)	192 of 240 (80%)	Not reported
VI-0521 Top	13 of 511 (2.5%)	432 of 511 (84.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28455281Guo 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.

Related trials for Obesity

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Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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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

5 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 in people with Obesity, run by VIVUS LLC at 5 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 6 inclusion and 16 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 6 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 56 (time frame: baseline to 56 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 NCT00554216, which also lists 1 linked publication.

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 10 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.