A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
Completed
Orexigen Therapeutics, Inc
Phase 2
2007-10-01
The purpose of this study is to determine whether a combination of naltrexone SR and
bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and
obese subjects.
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
Terminated
Orexigen Therapeutics, Inc
Phase 3
2012-06-01
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.
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
Completed
Orexigen Therapeutics, Inc
Phase 1
2014-09-01
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy
adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination
trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the
two drug products will be evaluated separately in the fed and fasted state.
Naltrexone/Bupropion Cardiovascular Outcomes Study
Terminated
Orexigen Therapeutics, Inc
Phase 4
2016-01-01
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone
hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo
and rule out excess risk of major adverse cardiovascular events (MACE) when given in
combination with standard of care in overweight and obese participants with documented
history of CV disease.
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
Active, not recruiting
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase 2/Phase 3
2017-02-27
This study will test the effectiveness and relative efficacy of behavioral and pharmacologic
treatments, alone and in combination, for the treatment of binge eating disorder (BED) in
patients with obesity. This is an acute treatment comparing behavioral weight loss alone or
in combination with naltrexone/bupropion medication.
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