Arena Pharmaceuticals to Continue BLOOM Obesity Trial
Arena Pharmaceuticals announced that an independent echocardiographic data safety monitoring board found no reason to stop the Behavioral modification and Lorcaserin for Overweight and Obesity Management (BLOOM) study, an ongoing pivotal Phase III trial of lorcaserin hydrochloride for the treatment of obesity.
BLOOM is a double-blind, randomized, placebo-controlled trial involving approximately 3,200 patients. The trial is evaluating a 20-mg daily dose of lorcaserin versus placebo over a two-year treatment period in obese patients with or without comorbid conditions and overweight patients with at least one comorbid condition.
The primary efficacy endpoint is the proportion of patients with a 5 percent or greater weight reduction from baseline at week 52 compared with placebo. Patients received echocardiograms at screening and six months after initiating dosing in the trial and will receive follow-up echocardiograms at 12, 18 and 24 months, Arena said.
The complete lorcaserin program includes two Phase III pivotal trials in addition to BLOOM that are scheduled to start later this year.