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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00553787
Enrollment
2487
Registered
2007-11-06
Start date
2007-11-30
Completion date
2009-06-30
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, Type 2 Diabetes

Keywords

Obesity, Type 2 diabetes

Brief 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.

Interventions

DRUGVI-0521

phentermine 15 mg and topiramate 92 mg, po once daily

Sponsors

Medpace, Inc.
CollaboratorINDUSTRY
VIVUS LLC
Lead SponsorINDUSTRY

Study design

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

Eligibility

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

Inclusion criteria

* 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); * 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frame
Percent Weight Loss From Baseline to Week 56Baseline to 56 weeks
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCFBaseline 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
Placebo994
VI-0521 Mid
7.5 mg/46 mg phentermine/topiramate
498
VI-0521 Top
15 mg/92 mg phentermine/topiramate
995
Total2,487

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event342167
Overall StudyLack of Efficacy3113
Overall StudyLost to Follow-up1324478
Overall Studynon compliance4011
Overall StudyOther181013
Overall StudyPregnancy012
Overall StudyRequirement for restricted medication875
Overall StudyWithdrawal by Subject1514083

Baseline characteristics

CharacteristicPlaceboVI-0521 MidVI-0521 TopTotal
Age Continuous51.2 years
STANDARD_DEVIATION 10.3
51.1 years
STANDARD_DEVIATION 10.4
51 years
STANDARD_DEVIATION 10.7
51.1 years
STANDARD_DEVIATION 10.4
Region of Enrollment
United States
994 participants498 participants995 participants2487 participants
Sex: Female, Male
Female
695 Participants349 Participants693 Participants1737 Participants
Sex: Female, Male
Male
299 Participants149 Participants302 Participants750 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
761 / 993424 / 498874 / 994
serious
Total, serious adverse events
40 / 99315 / 49850 / 994

Outcome results

Primary

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

Time frame: Baseline to 56 weeks

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

ArmMeasureValue (NUMBER)
PlaceboPercentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF20.8 percentage of participants
VI-0521 MidPercentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF62.1 percentage of participants
VI-0521 TopPercentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF70 percentage of participants
Comparison: With at least 500 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: [7.34, 11.11]Regression, Logistic
Comparison: With at least 500 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: [4.93, 7.97]Regression, Logistic
Comparison: With at least 500 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: 0.001895% CI: [1.15, 1.81]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 561.24 percent weight lossStandard Error 0.277
VI-0521 MidPercent Weight Loss From Baseline to Week 567.81 percent weight lossStandard Error 0.365
VI-0521 TopPercent Weight Loss From Baseline to Week 569.84 percent weight lossStandard Error 0.275
Comparison: With at least 500 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: [7.96, 9.25]ANCOVA
Comparison: With at least 500 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: [5.79, 7.37]ANCOVA
Comparison: With at least 500 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: [1.24, 2.82]ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026