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VI-0521

Phase 3

Obesity | Small molecule | Metabolic |Medpace Holdings, Inc. Common Stock|Last Updated: Mar 30, 2015

Development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Nov 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment5,186

FDA Designations

No designations recorded

Clinical trial landscape

VI-0521 · 4 trials · 2 indications

Phase 3 4
NCT00796367A 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)Obesity
COMPLETED676 Analytics
NCT00563368A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in AdultsObesity
COMPLETED756 Analytics
NCT00553787Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid ConditionsObesity
COMPLETED2,487 Analytics
NCT00554216Study of VI-0521 Compared to Placebo in Treatment of Obesity in AdultsObesity
COMPLETED1,267 Analytics
PHASE3COMPLETED
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)
Obesity
NCT00796367676
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PHASE3COMPLETED
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Obesity
NCT00563368756
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PHASE3COMPLETED
Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
Obesity
NCT005537872,487
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PHASE3COMPLETED
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
Obesity
NCT005542161,267
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Study Endpoints

Primary Endpoints

Percent Weight Change at End of Treatment, Week 108.
From baseline to end of treatment
Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
Baseline to End of Treatment
Percent Weight Loss From Baseline to Week 28
baseline to 28 weeks

Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)

Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
baseline to 28 weeks
Percent Weight Loss From Baseline to Week 56
Baseline to 56 weeks
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF
Baseline to 56 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 56
baseline to 56 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
VI-0521 MidEXPERIMENTAL7.5 mg phentermine and 46 mg topiramate
VI-0521 TopEXPERIMENTAL15 mg phentermine and 92 mg topiramate
TPM 46ACTIVE_COMPARATORmid dose topiramate
TPM 92ACTIVE_COMPARATORhigh dose topiramate
PHEN 7.5ACTIVE_COMPARATORmid dose phentermine
PHEN 15ACTIVE_COMPARATORhigh dose phentermine
VI-0521 LowEXPERIMENTALVI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)

Interventions

NameTypeDescription
VI-0521DRUG7.5 mg phentermine and 46 mg topiramate
PlaceboDRUGplacebo
topiramateDRUGtopiramate 46 mg, po once daily
phentermineDRUGphentermine 7.5 mg, po once daily
Placebo matched phentermine/topiramateDRUGPlacebo matched phentermine/topiramate
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 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 ...

Countries:United States
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Competitive Landscape -Obesity 180 trials

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