Conditions: Obesity
Keywords: obesity treatment weight loss antiobesity drugs zonisamide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 225
Healthy volunteers: no

Brief summary:
The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

Detailed description:
This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Arms:
arm 1: Zonisamide 400 mg arm 2: Zonisamide 200 mg arm 3: matching placebo

Interventions: intervention 1: Zonisamide
Intervention descriptions: intervention 1: zonisamide 400 mg, 200 mg, or placebo

Protocol document: