A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects

Phase 3 Completed 1742 enrolled Orexigen Therapeutics, Inc

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.

Timeline

Start: 2007-10
Primary completion: 2009-05
Completion: 2009-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); NB16 vs Placebo; p <0.001; Mean Difference (Net) -3.67 (95% CI -4.50 to -2.85); ANCOVA NCT00532779 ↗

registry analysis (superiority or other test); NB32 vs Placebo; p <0.001; Mean Difference (Net) -4.81 (95% CI -5.63 to -3.99); ANCOVA NCT00532779 ↗

registry analysis (superiority or other test); NB16 vs Placebo; p <0.001; Odds Ratio (OR) 3.42 (95% CI 2.52 to 4.63); Regression, Logistic NCT00532779 ↗

registry analysis (superiority or other test); NB32 vs Placebo; p <0.001; Odds Ratio (OR) 4.86 (95% CI 3.60 to 6.57); Regression, Logistic NCT00532779 ↗

Publications

Results Greenway FL, Fujioka K, Plodkowski RA, Mudaliar S, Guttadauria M, Erickson J, Kim DD, Dunayevich E; COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010 Aug 21;376(9741):595-605. doi: 10.1016/S0140-6736(10)60888-4. Epub 2010 Jul 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupropion	Small molecule	360 mg	Oral
Subject	Naltrexone	Small molecule	16 mg	Oral
Subject	Naltrexone	Small molecule	32 mg	Oral