NCT01764386

Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects

A Multicenter, Randomized, Open-Label, Controlled, Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects (The Ignite Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	NB	Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
BEHAVIORAL	CLI	The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.
BEHAVIORAL	Usual Care	Usual Care is a self-directed lifestyle intervention program

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-01-09
• Last updated: 2015-12-29
• Results posted: 2015-11-26

Locations

15 sites across 1 country: United States