A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: VI-0521; Drug: topiramate; Drug: phentermine

• Registration Number: NCT00563368
• Lead Sponsor: VIVUS LLC

Brief Summary

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-26
• Study Start: 2007-12
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2009-11-18
• Disposition First Submitted QC: 2009-11-18
• Disposition First Posted: 2009-11-20
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Results First Posted: 2012-09-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

• 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
• Informed Consent
• Females of child-bearing potential must be using adequate contraception

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
• Glaucoma or elevated intraocular pressure
• Pregnancy or breastfeeding
• Drug or Alcohol abuse
• Smoking cessation within previous 3 months or plans to quit smoking during study
• Eating disorders within past year
• Cholelithiasis within past 6 months
• Type 2 diabetes
• Previous bariatric surgery
• Bipolar disorder or psychosis
• Steroid hormone therapy not stable for 3 months
• Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	VI-0521	-
VI-0521 Top	VI-0521	VI-0521; high dose phentermine/topiramate
VI-0521 Mid	VI-0521	VI-0521; mid dose phentermine/topiramate
TPM 46	topiramate	mid dose topiramate
TPM 92	topiramate	high dose topiramate
PHEN 7.5	phentermine	mid dose phentermine
PHEN 15	phentermine	high dose phentermine

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States