ZB-202 is a randomized, double-blind, placebo-controlled trial involving approximately 720 generally healthy, nondiabetic obese patients at 20 sites nationwide. The primary endpoint for this trial is percent change in body weight after 24 weeks of blinded therapy.
Patients will be randomized to one of six treatment groups including two of the Empatic doses associated with weight loss in the previous Phase IIb trial. The efficacy of Empatic will be compared against zonisamide monotherapy, bupropion monotherapy and placebo. Trial results are expected in the second half of 2009.
The trial is designed to build on highly encouraging safety and efficacy results from a previous Phase IIb trial of Empatic, which demonstrated robust weight loss at 48 weeks ranging from approximately 11% to 15% in obese patients completing the trial and a discontinuation rate due to adverse events that was not significantly different than placebo.
Empatic combines zonisamide and bupropion, two existing drugs that have been independently approved by the FDA to treat other central nervous system disorders.
Gary Tollefson, Orexigen president and CEO, said: “Empatic continues to be an important component of the company’s obesity program. Along with Contrave, now in Phase III clinical trials, these product candidates both have the potential to target a large, distinct and complementary segment within the obesity market.”