A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects

Summary

The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity.

Timeline

Start

2007-12

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); NB32 vs Placebo; p <0.001; Mean Difference (Net) -4.56 (95% CI -5.19 to -3.93); ANCOVA NCT00567255 ↗

registry analysis (superiority or other test); NB32 vs Placebo; p <0.001; Odds Ratio (OR) 6.61 (95% CI 4.95 to 8.84); Regression, Logistic NCT00567255 ↗

Publications

• Results Apovian CM, Aronne L, Rubino D, Still C, Wyatt H, Burns C, Kim D, Dunayevich E; COR-II Study Group. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013 May;21(5):935-43. doi: 10.1002/oby.20309.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupropion	Small molecule	360 mg	—
Subject	Naltrexone	Small molecule	32 mg	—

Indications