The trial is evaluating a 20 mg daily dose (10 mg dosed twice daily) of lorcaserin versus placebo over a two-year treatment period in obese patients with or without co-morbid conditions and overweight patients with at least one co-morbid condition.
The proportion of patients with a 5% or greater weight reduction from baseline at week 52 is the primary efficacy endpoint.
In these additional trials Arena plans to evaluate the 20 mg and 10 mg daily doses versus placebo over a one-year treatment period, with one of the trials likely evaluating patients who also have type 2 diabetes. Diet and exercise will be part of each of the pivotal trials in accordance with the FDA guideline.
In addition to the above planned trial program, several other small studies, such as drug interaction and abuse potential studies, will be conducted.