The phase 3, randomized, open-label IGNITE trial was designed to evaluate the use of Contrave (naltrexone and bupropion extended-release tablets, Orexigen Therapeutics) in combination with a commercially available lifestyle-intervention program compared with usual care in a “real world” weight-loss setting. The results showed that treatment with Contrave, when used in a manner consistent with prescribing information in the United States, resulted in a significant reduction in body weight compared with usual care.
The IGNITE study evaluated 242 obese (body mass index [BMI]: 30 to 45 kg/m2) or overweight (BMI: 27 to 45 kg/m2) adults 18 to 60 years of age with dyslipidemia and/or controlled hypertension. During an initial 26-week controlled-treatment phase, the patients were randomly assigned to receive either Contrave in combination with a commercially available comprehensive lifestyle-intervention program (i.e., a telephone- and internet-based program that included a nutrition and exercise program with individualized goal-setting) or usual care (i.e., standard diet and exercise advice from the study site).
At week 16, participants receiving Contrave had to achieve at least 5% weight loss to continue therapy, consistent with U.S. prescribing information. The study’s primary endpoint was the percent change in body weight per protocol population; secondary endpoints included the percentage of patients achieving weight loss of at least 5%, 10%, or 15% of baseline body weight.
After 26 weeks of treatment, participants in the Contrave group lost significantly more weight compared with the usual-care group (9.5% versus 0.9%, respectively; P < 0.0001). In addition, significantly more Contrave-treated patients achieved three weight loss thresholds compared with those given usual care:
Significantly greater reductions in obesity-related risk factors were observed in Contrave-treated participants compared with those receiving usual care, including triglycerides, waist circumference, glucose, insulin, and a measure of insulin resistance. Contrave-treated participants also experienced a significantly greater increase in high-density lipoprotein (“good”) cholesterol.
Contrave, approved by the FDA in September 2014, is indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type-2 diabetes mellitus, or dyslipidemia).
Source: Orexigen Therapeutics; January 6, 2017.