Orexigen

Ongoing Clinical Trials

The Light Study

The Light Study is a multicenter, randomized, double-blind, placebo-controlled long-term research study of Contrave^® (naltrexone SR/bupropion SR), an investigational drug being evaluated for weight loss. The Light Study is designed to assess the cardiovascular health outcomes of Contrave.

The Light Study recruited men age 45 or older or women age 50 or older that need to lose weight, and also have a cardiovascular risk factor, such as heart disease or type 2 diabetes with certain heart risk factors.

People participating in the Light Study will also have access to WeightMate™, a comprehensive weight management program. 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 to help users achieve their health goals. WeightMate was developed in partnership between Orexigen and Sharecare.

For more information about the Light Study visit: http://clinicaltrials.gov/ct2/show/NCT01601704?term=contrave&rank=3

The Ignite Study

The Ignite Study is being conducted to assess the weight loss effects of the investigational drug Contrave® (naltrexone SR/bupropion SR), in a setting resembling likely “real-world” use post-approval, compared to the weight loss observed when subjects receive diet and exercise advice similar to that typically used by primary care providers. In this multicenter, open-label, controlled research study, subjects will be randomly assigned to one of two treatments for the initial 26 weeks of the study:

1)   Contrave®, used in combination with a comprehensive, personalized, highly-interactive and user-friendly lifestyle intervention program
2)   Conventional diet and exercise advice from the research site staff

In addition, subjects receiving Contrave will undergo an evaluation after 16 weeks of treatment and will only continue taking the medication if they have satisfied pre-determined safety and efficacy criteria, consistent with the anticipated recommendations for Contrave use post-approval. After 26 weeks, subjects who initially were part of the diet and exercise advice group will receive Contrave and participate in the comprehensive lifestyle program for the remainder of the study. The total study duration is 1.5 years.

People participating in the Ignite Study must either be overweight (BMI 27 to 30 kg/m²) with dyslipidemia or controlled hypertension, or obese (BMI between 30 and 45 kg/m²).

For more information about the Ignite Study, visit: http://clinicaltrials.gov/ct2/show/NCT01764386?term=orexigen&rank=2