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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults

Conditions
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Obesity

Intervention / Treatment
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* Drug: VI-0521
* Drug: VI-0521
* Drug: topiramate
* Drug: topiramate
* Drug: phentermine
* Drug: phentermine
* Drug: VI-0521


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VI-0521 Top<br>VI-0521; high dose phentermine/topiramate | Drug: VI-0521<br>* phentermine 15 mg and topiramate 92 mg, po once daily<br>|
| Experimental: VI-0521 Mid<br>VI-0521; mid dose phentermine/topiramate | Drug: VI-0521<br>* phentermine 7.5 mg and topiramate 46 mg, po once daily<br>|
| Active Comparator: TPM 46<br>mid dose topiramate | Drug: topiramate<br>* topiramate 46 mg, po once daily<br>|
| Active Comparator: TPM 92<br>high dose topiramate | Drug: topiramate<br>* topiramate 92 mg, po once daily<br>|
| Active Comparator: PHEN 7.5<br>mid dose phentermine | Drug: phentermine<br>* phentermine 7.5 mg, po once daily<br>|
| Active Comparator: PHEN 15<br>high dose phentermine | Drug: phentermine<br>* phentermine 15 mg, po once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: VI-0521<br>* placebo, po once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Loss From Baseline to Week 28 | Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF) | baseline to 28 weeks | 
| Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF |  | baseline to 28 weeks |