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news.The new data show that lorcaserin increased excess weight loss during Year 1 of the BLOOM trial
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Arena has reported that data from the pivotal BLOOM phase 3 trial demonstrate lorcaserin increased excess weight loss, improved markers of cardiovascular risk and glycemic parameters, and was not associated with depression or suicidal ideation.
Additional subgroup analyses showed that lorcaserin caused the improvements in lipid profiles, glycemic parameters and other markers of cardiovascular risk in patients in the risk categories. The new data were presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society.
Reportedly, the new data show that lorcaserin increased excess weight loss during Year 1 of the BLOOM trial. Lorcaserin patients who completed the trial according to protocol lost 31.0% of their excess weight compared to 12.0% for the placebo group. The measurement is based on a normal Body Mass Index, or BMI, of 25.
In addition to the previously announced improvements in glycemic parameters, including fasting glucose, fasting insulin and HOMA-IR, lorcaserin patients also achieved improvements in HbA1C over one year of treatment (p<0.0001). The improvements were observed in patients with abnormal baseline values, said the company.
In addition to the previously announced tolerability data, today’s presentation also reported that lorcaserin demonstrated no increase in depression or suicidal ideation compared to placebo. Depression and suicidal ideation were monitored prospectively using the Beck Depression Inventory-II (BDI-II) and by adverse event reporting. At Week 52, 18.0% of lorcaserin patients and 16.1% of placebo patients reported at least a five-point improvement from baseline in BDI-II.
Christen Anderson, vice president of clinical development at Arena, said: “Drug candidates that act on the central nervous system are currently under tremendous scrutiny for any association with depression or suicidal ideation. Lorcaserin’s selective activation of an important receptor associated with reduced food intake avoids these liabilities. We believe the data presented at Obesity 2009 will support our new drug application and we look forward to working with the FDA to provide physicians and patients with lorcaserin.”