Eisai Inc. announced that patient recruitment and enrollment are currently underway for CAMELLIA-TIMI 61, a randomized double-blind, placebo-controlled outcomes trial to evaluate the effect of long-term treatment with lorcaserin HCl on the incidence of major adverse cardiovascular events and new onset type 2 diabetes mellitus in obese and overweight patients with cardiovascular disease or cardiovascular risk factors.
The completion of this study will satisfy the postmarketing requirement from the U.S. Food and Drug Administration (FDA) to evaluate the long-term cardiovascular safety of lorcaserin HCl, marketed as Belviq. The five-year, multicenter study, conducted in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, will include approximately 12,000 patients at 700 sites in 14 countries around the world.
"This robust global study underscores Eisai's commitment to improving human health care and will generate important data about the long-term safety and efficacy of lorcaserin HCl in overweight and obese patients, including the effects on comorbid risk factors associated with obesity," said Andrew Satlin, executive vice president, Neuroscience and General Medicine PCU, Eisai Inc.
Belviq (lorcaserin HCl) CIV is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if Belviq is safe and effective when taken with other prescription, over-the-counter or herbal weight loss products, nor is it known if Belviq changes the risk of heart problems or stroke, or death due to heart problems or stroke.
Belviq is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of Belviq is not known.
"Obesity is a major problem globally with serious cardiovascular implications," said Marc Sabatine, chairman, TIMI Study Group, Brigham and Women's Hospital. "This study, led by Drs. Benjamin Scirica and Stephen Wiviott from the TIMI Study Group, represents a rigorous evaluation of the effects of lorcaserin HCl as a metabolic intervention on cardiovascular health."
Date: February 24, 2014