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Arena Pharmaceuticals Initiates Second and Third Pivotal Trials Evaluating Lorcaserin for the Treatment of Obesity
Date:12/13/2007

cant and positive variation in the protocol for the second two pivotal trials," commented Steven R. Smith, M.D., principal investigator in the study and Professor at the Pennington Biomedical Research Center. "This change will allow the pivotal trial program to more fully explore, and develop a more complete understanding of, lorcaserin's selective mechanism and its safety profile."

"Given the prevalence and impact of obesity, patients and their physicians need new treatment options," commented Lee M. Kaplan, M.D., Ph.D., an investigator in the BLOOM, BLOOM-DM and BLOSSOM pivotal trials, Director of the Massachusetts General Hospital Weight Center and Associate Professor of Medicine at Harvard Medical School. "Including a broader representation of overweight patients and patients with obesity as part of the pivotal trial program for lorcaserin, including individuals with more significant valvulopathy and type 2 diabetes, is important for providing a more complete assessment of the safety and efficacy of this agent," concluded Dr. Kaplan.

The BLOSSOM trial will evaluate 10 mg and 20 mg daily doses (10 mg dosed once or twice daily) of lorcaserin versus placebo over a one-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to 29.9) with at least one co-morbid condition at about 100 sites in the United States. The BLOOM-DM trial will evaluate 10 mg and 20 mg daily doses of lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus at about 45 sites in the United States.

Consistent with the BLOOM trial, diet and exercise will also be included in the BLOSSOM and BLOOM-DM trials in accordance with current FDA guidelines, and the proportion of patients with a 5% or greater weight reduction from baseline at week 52 will be the primary efficacy endpoint. Secondary endpoints include changes in serum lip
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