The IGNITE study was a Phase 3b, open-label, randomized study (n=242) that evaluated the use of Contrave (naltrexone HCl and bupropion HCl extended-release tablets) in combination with a commercially-available comprehensive lifestyle intervention program versus usual care in a real-world weight-loss setting. Study patients were obese or overweight adults aged 18–60 years with dyslipidemia and/or controlled hypertension. 

By Week 16, patients treated with Contrave had to achieve ≥5% weight loss to continue therapy. The primary endpoint was the percent change in body weight per protocol population. Secondary endpoints included percentage of patients achieving ≥5%, ≥10%, or ≥15% weight loss.  

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At Week 26, the data showed patients treated with Contrave lost significantly more weight vs. usual care patients (9.5% vs. 0.9%; P<0.0001). Significantly more patients treated with Contrave achieved three weight loss thresholds than usual care-treated patients: ≥5% weight loss was seen in 84.5% vs. 12.2%, respectively; ≥10% weight loss was seen in 42.3% vs. 3.7%, respectively; and ≥15% weight loss was seen in 12.7% vs. 0%, respectively. 

In addition, significantly greater reductions in obesity-related factors were seen in patients treated with Contrave vs. usual care, including triglycerides, waist circumference, glucose, insulin, and a measure of insulin resistance. A significantly greater increase in high density lipoprotein (HDL) cholesterol was also seen in patients treated with Contrave. 

Contrave was approved in September 2014 for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbidity (eg, hypertension, type 2 diabetes mellitus, dyslipidemia). 

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