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news.Arena Pharmaceuticals has initiated patient screening in the second and third Phase III pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for weight management in overweight and obese patients.
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Known as BLOSSOM (behavioral modification and lorcaserin second study for obesity management) and BLOOM-DM (behavioral modification and lorcaserin for overweight and obesity management in diabetes mellitus), these one-year, double-blind, randomized and placebo-controlled trials are expected to collectively enroll approximately 3,750 overweight and obese patients.
William Shanahan, Arena’s vice president and chief medical officer, said: “As we continue advancing our lorcaserin clinical program, we are looking forward to March 2008 when we expect the BLOOM echocardiographic safety monitoring board’s review of echocardiograms for patients completing 12 months of treatment. We will continue to work with the FDA as we implement the final non-pivotal trial elements of the complete Phase III program.”