Conditions: Obesity
Keywords: Obesity, morbid obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1267
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Detailed description:

Arms:
arm 1: VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) arm 2: Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. arm 3: Placebo to match

Interventions: intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: Placebo matched phentermine/topiramate
Intervention descriptions: intervention 1: 3.75 mg phentermine/23 mg topiramate intervention 2: 15 mg phentermine/92 mg topiramate intervention 3: Placebo matched phentermine/topiramate

Protocol document: