ObesityPhase 3NCT00553787

Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

A Phase 3 study testing VI-0521 in people with Obesity and Type 2 Diabetes, run by VIVUS LLC at 6 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

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obesity, Type 2 Diabetes
What is being tested?: VI-0521
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,487 participants
Where: 6 sitesUnited States
Study dates: Nov 2007to Jun 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

Informed Consent
BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
70 years of age or less
Have 2 or more of the following obesity-related co-morbid conditions:
Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);

Show all 13Show fewer

Requirement for 2 or more medications to achieve control (<140/90 mmHg)
Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)
At lease one of the following metabolic criteria:
Fasting blood glucose level > 100 mg/dL
Glucose level > 140 mg/dL
Diagnosis of type 2 diabetes
Waist circumference ≥ 102 cm for men or ≥88 cm for women

Who cannot join

Stroke/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 19Show fewer

Glaucoma or intraocular pressure
Pregnancy or breastfeeding
Drug or 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 1 diabetes or use of any antidiabetic medication other than metformin
Previous bariatric surgery
Bipolar disorder or psychosis
Steroid hormone therapy
Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Creatinine clearance < 60 mL/minute

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Research Site
Austin, Texas, 78731
Research Site
Birmingham, Alabama, 35294
Research Site
Durham, North Carolina, 27710
Research Site
New York, New York, 10025
Research Site
Ridgefield, Connecticut, 06877
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 Adults With Obesity-Related Co-Morbid Conditions

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Conditions: Obesity, Type 2 Diabetes
Being tested: VI-0521
Keywords: Obesity, Type 2 diabetes
Medical subject headings: Obesity, Diabetes Mellitus, Type 2

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
VI-0521Drug
placebo

Study groups in NCT00553787
Study group	Role	What they receive
VI-0521 Top	Experimental	high dose experimental treatment Receives: Drug: VI-0521
VI-0521 Mid	Experimental	mid dose experimental treatment Receives: Drug: VI-0521
Placebo	Placebo comparator	Placebo 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 56
Measured: Baseline to 56 weeks
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF
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 2007Jun 2009

First posted6 Nov 2007 (estimated)
Study startNov 2007
Primary completionJun 2009
Study completionJun 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 (3)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,487 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00553787
Sponsor's protocol ID: OB-303
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
Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.
PubMed 25249652
Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, Day WW. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Apr 16;377(9774):1341-52. doi: 10.1016/S0140-6736(11)60205-5. Epub 2011 Apr 8.
PubMed 21481449

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 Adults With Obesity-Related Co-Morbid Conditions
ClinicalTrials.gov ID: NCT00553787
Acronym / sponsor ID: OB-303
Conditions: Obesity, Type 2 Diabetes
Keywords: Obesity, Type 2 diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,487 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: Medpace, Inc.
Study start: Nov 2007
Primary completion: Jun 2009 (actual)
Study completion: Jun 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 VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Study design

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

Arm	Type	Receives
VI-0521 Top	Experimental	Drug: VI-0521high dose experimental treatment
VI-0521 Mid	Experimental	Drug: VI-0521mid dose experimental treatment
Placebo	Placebo comparator	Drug: VI-0521Placebo

Who may qualify

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

Key inclusion criteria (13 listed)

Informed Consent
BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
70 years of age or less
Have 2 or more of the following obesity-related co-morbid conditions:
Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)

Key exclusion criteria (19 listed)

Stroke/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
VI-0521placebo	Drug	Placebo

Primary outcome

Percent Weight Loss From Baseline to Week 56
Time frame: Baseline to 56 weeks
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF
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	994	616
VI-0521 Mid	498	374
VI-0521 Top	995	733

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 = 979	VI-0521 Mid n = 488	VI-0521 Top n = 981
Value	1.24 (0.277)	7.81 (0.365)	9.84 (0.275)

Placebo vs VI-0521 Top: Mean Difference (Final Values): 8.6 (95% CI 7.96 to 9.25), p <0.0001, ANCOVA
Placebo vs VI-0521 Mid: Mean Difference (Final Values): 6.58 (95% CI 5.79 to 7.37), p <0.0001, ANCOVA
VI-0521 Mid vs VI-0521 Top: Mean Difference (Final Values): 2.03 (95% CI 1.24 to 2.82), p <0.0001, ANCOVA

Population analysed: intent-to-treat last-observation-carried-forward (ITT-LOCF)

Primary outcome: Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF

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

Measure	Placebo n = 979	VI-0521 Mid n = 488	VI-0521 Top n = 981
Value	20.8	62.1	70

Placebo vs VI-0521 Top: Odds Ratio (OR): 9.03 (95% CI 7.34 to 11.11), p <0.0001, Regression, Logistic
Placebo vs VI-0521 Mid: Odds Ratio (OR): 6.27 (95% CI 4.93 to 7.97), p <0.0001, Regression, Logistic
VI-0521 Mid vs VI-0521 Top: Odds Ratio (OR): 1.44 (95% CI 1.15 to 1.81), p = 0.0018, 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	40 of 993 (4%)	761 of 993 (76.6%)	Not reported
VI-0521 Mid	15 of 498 (3%)	424 of 498 (85.1%)	Not reported
VI-0521 Top	50 of 994 (5%)	874 of 994 (87.9%)	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 25249652Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.
Derived from this study: PubMed 21481449Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, Day WW. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Apr 16;377(9774):1341-52. doi: 10.1016/S0140-6736(11)60205-5. Epub 2011 Apr 8.

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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

6 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 and Type 2 Diabetes, run by VIVUS LLC at 6 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 13 inclusion and 19 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 6 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 NCT00553787, which also lists 3 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.