Conditions: Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 756
Healthy volunteers: no

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:

Arms:
arm 1: VI-0521; high dose phentermine/topiramate arm 2: VI-0521; mid dose phentermine/topiramate arm 3: mid dose topiramate arm 4: high dose topiramate arm 5: mid dose phentermine arm 6: high dose phentermine arm 7: None

Interventions: intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: topiramate intervention 4: topiramate intervention 5: phentermine intervention 6: phentermine intervention 7: VI-0521
Intervention descriptions: intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: topiramate 46 mg, po once daily intervention 4: topiramate 92 mg, po once daily intervention 5: phentermine 7.5 mg, po once daily intervention 6: phentermine 15 mg, po once daily intervention 7: placebo, po once daily

Protocol document: