NCT01601704

Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,910 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	NB32	Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
DRUG	PBO	Placebo. Administered in addition to the weight management program.
BEHAVIORAL	Weight Management Program	A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2012-05-18
• Last updated: 2017-02-27
• Results posted: 2017-02-27

Locations

224 sites across 1 country: United States