Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported pooled Week 52 data from more than 6,000 patients in lorcaserin's pivotal Phase 3 clinical trial program that demonstrate lorcaserin 10 mg dosed twice daily reduced body weight in all patient subgroups evaluated, as defined by gender, age, ethnicity and starting body weight and Body Mass Index (BMI). Greater improvements in cardiovascular risk factors were also achieved with lorcaserin treatment compared to placebo overall and in most subgroups.
The pooled data show that more than twice as many lorcaserin patients (47.1%) achieved at least 5% body weight loss compared to placebo (22.6%) using Intent-to-Treat with Last Observation Carried Forward analysis. Patients in both the lorcaserin and placebo groups who decreased their body weight by at least 5% achieved more favorable changes in lipid parameters, glycemic parameters, blood pressure and high sensitivity C-reactive protein as compared to those who had less than 5% weight loss. Greater improvements in these cardiovascular risk factors were also achieved by patients who entered the studies with values indicative of elevated risk.
William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer, stated, "In our pivotal program, patients who achieved at least 5% weight loss benefited from greater improvements in cardiovascular risk factors, and the proportion of lorcaserin patients that achieved this amount of weight loss was double the placebo rate."
The data show that patients who took lorcaserin achieved greater reductions in body weight than the placebo group in all subgroups evaluated. Lorcaserin patients achieved greater improvements in total cholesterol, triglycerides, HDL cholesterol and insulin resistance compared to placebo across all subgroups. Greater improvements were also seen in fasting insulin, fasting glucose and blood pressure for lorcaserin patients compared to placebo overall and in most subgroups. Blood pressure did not increase in any evaluated subgroup.
Christen M. Anderson, M.D., Ph.D., Arena's Vice President of Clinical Development, stated, "The pooled Phase 3 data show that lorcaserin successfully treated a diverse population of adult women and men who needed to lose weight. Lorcaserin's effect on weight loss also led to improvements in cardiovascular risk factors in all subgroups evaluated."