Phase 3 Studies of Lorcaserin for Weight Loss
Arena Pharmaceuticals presented meta-analyses of three Phase 3 trials of lorcaserin for the treatment of obesity. A total of 7,794 patients were randomized, and 7,500 patients were included in the primary efficacy analyses (MITT-LOCF), which required a patient to have taken at least one dose of study medication and have had at least one weight measurement subsequent to baseline. At one year, using Modified Intent-to-Treat with Last Observation Carried Forward analysis (MITT-LOCF) of the integrated results, 46.3% of lorcaserin 10mg twice daily patients and 40.6% of lorcaserin 10mg once daily patients achieved at least 5% weight loss, compared to 22.1% of patients on placebo, and 22% of lorcaserin 10mg twice daily patients and 17.3% of lorcaserin 10mg once daily patients achieved at least 10% weight loss, compared to 8.3% of patients on placebo.
The integrated Year 1 results also showed favorable statistically significant effects with lorcaserin 10mg twice daily treatment compared to placebo for secondary endpoints of cardiovascular and metabolic measures. The analyses show that lorcaserin caused statistically significant weight loss compared to placebo at one year among the 7,500 obese and overweight, diabetic and non-diabetic adults. In response to the NDA submitted for lorcaserin in December 2009, the FDA issued a Complete Response Letter in October 2010 and Arena Pharmaceuticals is currently addressing issues raised by the FDA.
Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism.
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