Comparison of Combined Bupropion and Naltrexone Therapy for Obesity with Monotherapy and Placebo
Abstract
CONTEXT: The efficacy of current centrally acting obesity pharmacotherapies is limited by compensatory mechanisms that mitigate weight loss. OBJECTIVE: Our objective was to determine whether opioid receptor antagonism (naltrexone) plus pro-opiomelanocortin activation (bupropion) causes greater weight loss than placebo or monotherapy. DESIGN/SETTING: A randomized, placebo- and monotherapy-controlled, double-blind, dose-finding trial was conducted from August 2005 to December 2006 in seven U.S. outpatient clinics. PARTICIPANTS: A total of 419 patients with uncomplicated obesity participated. INTERVENTIONS: Interventions included 24 wk of sustained-release bupropion (400 mg/d), immediate-release naltrexone (48 mg/d), placebo, and three combination therapy [naltrexone/bupropion (NB)] groups consisting of immediate-release naltrexone, 16, 32, or 48 mg/d, plus sustained-release bupropion (400 mg/d) with a 24-wk extension. A minimal diet and exercise component was also included. MAIN OUTCOME MEASURES: Percent weight change from baseline at wk 24 in the intent-to-treat population for NB48 vs. placebo and monotherapy was assessed. Other measurements included body mass index, waist circumference, fasting lipids, glycemic variables, safety, and tolerability. RESULTS: At wk 24, placebo-subtracted weight loss was -4.62% [95% confidence interval (CI) -6.24 to -2.99; P < 0.001] for NB16, -4.65% (95% CI -6.20 to -3.09; P < 0.001) for NB32, and -3.53% (95% CI -5.15 to -1.90; P < 0.001) for NB48. Weight loss was statistically significant vs. monotherapy for all three NB combinations with the exception of NB48 vs. bupropion. Weight loss with NB continued after wk 24. The most common treatment-emergent adverse event was mild transient nausea. CONCLUSIONS: NB caused gradual sustained weight loss over 48 wk; NB32 and NB16 demonstrated greater weight loss in the intent-to-treat population due to lower attrition rates. Further study is needed to demonstrate long-term efficacy and safety of NB.
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Secondary analyses show benefits of naltrexone/bupropion on binge frequency and global impressions of severity.
“Secondary analyses show the benefits of binge frequency and global impressions of severity [139].”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [139]
The Measurements section lists secondary and exploratory outcomes but does not include binge frequency or global impressions of severity. Searches for those terms found no results for either outcome in our copy. The Food craving and food obsession outcomes section reports no meaningful treatment effects, but those are different measures and do not establish the claimed benefits. (LLM, conf=0.76)
Experimental — accuracy not yet measuredHighly effective anti-obesity medications, including nutrient-stimulated hormone-based therapies, produce mean weight loss of 15% or more.
“Highly-effective AOMs, including nutrient-stimulated hormone-based therapies, induce mean weight loss of 15% or more.”
From Approach to Obesity Treatment in Primary Care: A Review (2024) · cites this paper as [68]
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- Authors
- Greenway, F. L., Dunayevich, E., Tollefson, G., Erickson, J., Guttadauria, M., Fujioka, K., Cowley, M. A., & for the NB-201 Study Group
- Affiliations
- Pennington Biomedical Research Center (US)
- Orexigen Therapeutics (United States) (US)
- Indiana University School of Medicine (US)
- MG Consulting, Inc. (M.G.), New York, New York 10462
- Scripps Health (US)
- Corresponding author
- Greenway, Frank L.
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2009-12-01
- Volume
- 94
- Issue
- 12
- Pages
- 4898-4906
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2036089668
- Cited by
- 179
- References
- 24
- Citations by year
- 2026: 4 · 2025: 12 · 2024: 7 · 2023: 4 · 2022: 5 · 2021: 9 · 2020: 11 · 2019: 10 · 2018: 8 · 2017: 9 · 2016: 13 · 2015: 17 · 2014: 12 · 2013: 14 · 2012: 10
- FWCI
- 10.48
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Louisiana State University
- Orexigen Therapeutics
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- obesity, bupropion, naltrexone, combination pharmacotherapy, weight loss, opioid antagonism, proopiomelanocortin, sustained weight loss, dose-finding, nausea, fasting lipids, glycemic control, waist circumference, body mass index, diet and exercise, treatment discontinuation, drug safety and tolerability
- MeSH terms
- Adolescent, Adult, Appetite, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Naltrexone, Narcotic Antagonists, Obesity, Risk Factors, Cohort Studies, Weight Loss, Bupropion, Dopamine Uptake Inhibitors, Endpoint Determination, Positron-Emission Tomography, Young Adult
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