Individuals may qualify for the Light Study if they are men age 45 or older or women age 50 or older; need to lose weight; and have a cardiovascular risk factor, such as heart disease or type 2 diabetes with certain heart risk factors.
In addition to the potential to receive Contrave, all who qualify and choose to participate in the Light Study will be part of an innovative, comprehensive weight management program called WeightMate™. Delivered through an internet-based platform by accredited health and fitness professionals, WeightMate provides a convenient, progressive nutrition and exercise program with goal setting and tracking tools. WeightMate is powered by Sharecare®, an interactive health and wellness social platform providing people with access to expert-developed answers, information and programs to live their healthiest life. Sharecare was created by Jeff Arnold, the founder of WebMD, and Dr. Mehmet Oz of "The Dr. Oz Show", to connect individuals with health experts and simplify the search for high-quality healthcare information.
"The Light Study is truly an innovative clinical trial, and we are honored to be working with such a high caliber team of advisors and partners in its execution," Narachi said. "We are committed to enrolling the Light Study expeditiously so that we have the opportunity to resubmit the Contrave New Drug Application for review by the United States Food and Drug Administration as early as possible."
About Contrave®Contrave (naltrexone SR/bupropion SR) is an investigational medication being evaluated for weight loss. Contrave has been studied to date in clinical trials enrolling more than 4,500 people and was developed by Orexigen to reduce appetite, help control cravings, increase metabolism and improve control over eating behaviors. Contrave has been shown to help people lose weight and keep it off for up to one year. In previous clinical trials, 53 percent of study participants taking Contrave and 21 percent of those taking placebo lost five percent or more of their body weight over the 12 month trial duration. Those who took Contrave for six months, combined with a structured weight management program, lost an average of 25 pounds, compared with 17 pounds for those using the weight management program and receiving placebo. Many patients saw noticeable improvements in cholesterol levels, and blood sugar control, as well as smaller waistlines. Those who combined Contrave with diet and exercise experienced the most reduction in body weight. There is no guarantee that Contrave will make patients lose weight.