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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
756
phentermine 15 mg and topiramate 92 mg, po once daily
phentermine 7.5 mg and topiramate 46 mg, po once daily
topiramate 46 mg, po once daily
Research Site
Durham, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Percent Weight Loss From Baseline to Week 28
Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)
Time frame: baseline to 28 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
Time frame: baseline to 28 weeks
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topiramate 92 mg, po once daily
phentermine 7.5 mg, po once daily
phentermine 15 mg, po once daily
placebo, po once daily