SAN DIEGO, Feb. 5 (UPI) -- U.S. firm Arena Pharmaceuticals said Monday it has finished enrolling 3,182 patients in a phase 3 trial of its obesity drug Lorcaserin.
The company said the phase 3 study is one of a trio of planned trials to test the new weight-loss treatment.
The placebo-based trial -- dubbed BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) -- will take place at about 100 U.S. sites, Arena said.
An independent Data Safety Monitoring Board overseeing the study will conduct a six-month review of patient echocardiograms in the third quarter and decide on whether it is safe to continue the trial.
"Completing the enrollment of more than 3,100 patients in the BLOOM trial in a little over four months reflects the significant need for additional options in the treatment of obesity," said William Shanahan, Arena's vice president and chief medical officer.
The BLOOM trial will evaluate Lorcaserin at a 20-mg daily dose versus placebo over two years in patients with a body mass index of 30 to 45 with or without comorbid conditions and in overweight patients -- or those with a BMI of 27 to 30 -- with at least one comorbid condition.
The study investigator will assess how many patients have lost 5 percent or more of their weight at one year.
Source:http://www.upi.com/HealthBusiness |
