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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00554216
Enrollment
1267
Registered
2007-11-06
Start date
2007-11-30
Completion date
2009-05-31
Last updated
2012-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, morbid obesity

Brief 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.

Interventions

DRUGVI-0521

3.75 mg phentermine/23 mg topiramate

DRUGPlacebo matched phentermine/topiramate

Placebo matched phentermine/topiramate

Sponsors

Medpace, Inc.
CollaboratorINDUSTRY
VIVUS LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

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

Countries

United States

Participant flow

Recruitment details

Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008

Participants by arm

ArmCount
Placebo514
VI-0521 Low
PHEN/TPM 3.75/23
241
VI-0521 Top
PHEN/TPM 15/92
512
Total1,267

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event161636
Overall StudyLack of Efficacy1530
Overall StudyLost to Follow-up923163
Overall StudyNon compliance1045
Overall StudyOther12710
Overall StudyPregnancy2114
Overall StudyRestricted med311
Overall StudyWithdrawal by Subject923143

Baseline characteristics

CharacteristicPlaceboVI-0521 LowVI-0521 TopTotal
Age Continuous43.0 years
STANDARD_DEVIATION 11.76
43.0 years
STANDARD_DEVIATION 10.96
42.0 years
STANDARD_DEVIATION 12.21
42.6 years
STANDARD_DEVIATION 11.8
Region of Enrollment
United States
514 participants241 participants512 participants1267 participants
Sex: Female, Male
Female
425 Participants201 Participants424 Participants1050 Participants
Sex: Female, Male
Male
89 Participants40 Participants88 Participants217 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
374 / 513192 / 240432 / 511
serious
Total, serious adverse events
14 / 5136 / 24013 / 511

Outcome results

Primary

Percentage of Subjects With at Least 5% Weight Loss at Week 56

Time frame: baseline to 56 weeks

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

ArmMeasureValue (NUMBER)
PlaceboPercentage of Subjects With at Least 5% Weight Loss at Week 5617.3 percentage of participants
VI-0521 LowPercentage of Subjects With at Least 5% Weight Loss at Week 5644.9 percentage of participants
VI-0521 TopPercentage of Subjects With at Least 5% Weight Loss at Week 5666.7 percentage of participants
Comparison: With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.p-value: <0.000195% CI: [7.13, 12.95]Regression, Logistic
Comparison: With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.p-value: <0.000195% CI: [2.8, 5.63]Regression, Logistic
Comparison: With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.p-value: <0.000195% CI: [1.76, 3.33]Regression, Logistic
Primary

Percent Weight Loss From Baseline to Week 56

Time frame: baseline to 56 weeks

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
PlaceboPercent Weight Loss From Baseline to Week 561.55 percent weight lossStandard Error 0.395
VI-0521 LowPercent Weight Loss From Baseline to Week 565.10 percent weight lossStandard Error 0.538
VI-0521 TopPercent Weight Loss From Baseline to Week 5610.92 percent weight lossStandard Error 0.392
Comparison: With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.p-value: <0.000195% CI: [8.43, 10.3]ANCOVA
Comparison: With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.p-value: <0.000195% CI: [2.38, 4.71]ANCOVA
Comparison: With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.p-value: <0.000195% CI: [4.65, 6.99]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026