ObesityPhase 3NCT00796367

A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)

A Phase 3 study testing VI-0521 in people with Obesity, run by VIVUS LLC.

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 long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787). 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: 676 participants
Where: No sites listed yet
Study dates: Dec 2008to Jul 2010
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

To be eligible for enrollment into this study, subjects must meet all of the following criteria:
Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements
Written informed consent
Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

Subjects will not be included in the study if they meet any of the following:
Body mass index ≤22 kg/m2 at the completion of study OB-303
Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart
Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results
Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).

About this study

Official title: A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.

Conditions: Obesity
Being tested: VI-0521, Placebo
Keywords: Obesity
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
Also called Qsymia, Qnexa, PHEN/TPM
7.5 mg phentermine and 46 mg topiramate
PlaceboDrug
placebo
VI-0521Drug
Also called Qsymia, Qnexa, PHEN/TPM
15 mg phentermine and 92 mg topiramate

Study groups in NCT00796367
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
VI-0521 Mid	Experimental	7.5 mg phentermine and 46 mg topiramate Receives: Drug: VI-0521
VI-0521 Top	Experimental	15 mg phentermine and 92 mg topiramate Receives: Drug: VI-0521

What is being measured

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

Percent Weight Change at End of Treatment, Week 108.
Measured: From baseline to end of treatment
Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
Measured: Baseline to End of Treatment

Timeline

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

Dec 2008Jul 2010

First posted24 Nov 2008 (estimated)
Study startDec 2008
Primary completionJun 2010
Study completionJul 2010

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 (2)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 676 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00796367
Sponsor's protocol ID: OB-305
Status last verified: Sep 2012
First submitted: 20 Nov 2008
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
Garvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, Day WW, Bowden CH. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012 Feb;95(2):297-308. doi: 10.3945/ajcn.111.024927. Epub 2011 Dec 7.
PubMed 22158731

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?

Official record

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All Obesity trials

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 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.
ClinicalTrials.gov ID: NCT00796367
Acronym / sponsor ID: OB-305
Conditions: Obesity
Keywords: Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 676 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: Medpace, Inc.
Study start: Dec 2008
Primary completion: Jun 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 24 Nov 2008 (estimated)
Results: Posted 31 Aug 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: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo
VI-0521 Mid	Experimental	Drug: VI-05217.5 mg phentermine and 46 mg topiramate
VI-0521 Top	Experimental	Drug: VI-052115 mg phentermine and 92 mg topiramate

Who may qualify

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

Key inclusion criteria (5 listed)

To be eligible for enrollment into this study, subjects must meet all of the following criteria:
Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements
Written informed consent
Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Key exclusion criteria (5 listed)

Body mass index ≤22 kg/m2 at the completion of study OB-303
Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart
Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results
Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).

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-0521Also: Qsymia, Qnexa, PHEN/TPM7.5 mg phentermine and 46 mg topiramate	Drug	VI-0521 Mid
Placeboplacebo	Drug	Placebo
VI-0521Also: Qsymia, Qnexa, PHEN/TPM15 mg phentermine and 92 mg topiramate	Drug	VI-0521 Top

Primary outcome

Percent Weight Change at End of Treatment, Week 108.
Time frame: From baseline to end of treatment
Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
Time frame: Baseline to End of Treatment

Results and safety

Results posted to the registry on 31 Aug 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	227	197
VI-0521 Mid	154	129
VI-0521 Top	295	248

Primary outcome: Percent Weight Change at End of Treatment, Week 108.

Time frame: From baseline to end of treatment. Least squares mean (Standard Error). Unit: percent weight loss

Measure	Placebo n = 227	VI-0521 Mid n = 153	VI-0521 Top n = 295
Value	-1.8 (0.55)	-9.32 (0.67)	-10.5 (0.5)

Placebo vs VI-0521 Top: Mean Difference (Final Values): 8.71 (95% CI 7.39 to 10.03), p <0.0001, ANCOVA
Placebo vs VI-0521 Mid: Mean Difference (Final Values): 7.52 (95% CI 5.95 to 9.09), p <0.0001, ANCOVA
VI-0521 Mid vs VI-0521 Top: Mean Difference (Final Values): 1.19 (95% CI -0.31 to 2.68), p = 0.1189, ANCOVA

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

Primary outcome: Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.

Time frame: Baseline to End of Treatment. Number. Unit: percent participants

Measure	Placebo n = 227	VI-0521 Mid n = 153	VI-0521 Top n = 295
Value	30	75.2	79.3

Placebo vs VI-0521 Top: Odds Ratio (OR): 9.4 (95% CI 6.24 to 14.16), p <0.0001, Regression, Logistic
Placebo vs VI-0521 Mid: Odds Ratio (OR): 6.99 (95% CI 4.36 to 11.19), p <0.0001, Regression, Logistic
VI-0521 Mid vs VI-0521 Top: Odds Ratio (OR): 1.35 (95% CI 0.84 to 2.15), p = 0.2169, 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 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	9 of 227 (4%)	182 of 227 (80.2%)	Not reported
VI-0521 Mid	4 of 153 (2.6%)	111 of 153 (72.5%)	Not reported
VI-0521 Top	13 of 295 (4.4%)	234 of 295 (79.3%)	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.
Derived from this study: PubMed 22158731Garvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, Day WW, Bowden CH. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012 Feb;95(2):297-308. doi: 10.3945/ajcn.111.024927. Epub 2011 Dec 7.
VIVUS company websiteLink provided by the sponsor.

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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

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.

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 5 inclusion and 5 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.

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 31 Aug 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 Change at End of Treatment, Week 108. (time frame: From baseline to end of treatment). 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 NCT00796367, which also lists 2 linked publications.

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.