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Arena Pharmaceuticals Announces Lorcaserin Phase 2b Clinical Trial Results Published in Obesity
Date:12/8/2008

ches to the obesity epidemic," said Jack Lief, Arena's President and Chief Executive Officer. "We are confident the three ongoing lorcaserin Phase 3 trials will build on the clinical data published today, and we eagerly anticipate the announcement of our first Phase 3 data from the BLOOM trial around the end of March 2009. We expect the top-line BLOOM data will be followed by a peer reviewed presentation of the data at a conference later in the year, the announcement of BLOSSOM data in the Fall, and the submission of our New Drug Application to the FDA by the end of 2009."

A summary of results from this study were presented previously at the 2006 American Diabetes Association Scientific Sessions.

Study Design

The Phase 2b clinical trial evaluated the efficacy and safety of three doses of lorcaserin over a 12-week period in non-diabetic, obese patients. The trial was a randomized, double-blind, placebo-controlled study conducted at approximately 40 sites in the United States. The trial enrolled 469 men and women with a Body Mass Index (BMI) ranging from 30 to 45. Patients were randomized into four groups, receiving 10 mg once daily, 15 mg once daily, or 10 mg twice daily of lorcaserin, or placebo. The primary efficacy endpoint was a reduction in weight from baseline at the end of 12 weeks. There was no run-in period, and patients were counseled to maintain their usual diet and physical activity. Patients received echocardiograms at screening and the completion of the study (day 85).

Study Results

Patients completing 12 weeks of treatment with lorcaserin achieved progressive, dose-dependent and highly statistically significant weight loss of 4 pounds (1.8 kg), 5.7 pounds (2.6 kg) and 7.9 pounds (3.6 kg) at daily doses of 10 mg, 15 mg and 20 mg (10 mg twice daily), respectively, compared to weight loss of 0.7 pounds (0.3 kg) for placebo (p<0.001 for each group). Similar res
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SOURCE Arena Pharmaceuticals, Inc.
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