Randomised controlled trials
In the trials below, people were assigned at random to take Naltrexone / Bupropion ER or a dummy pill (placebo). All the weight loss figures are averages: how much body weight fell from the start.
| Trial | Key result | Source |
|---|---|---|
| [1]COR-I | 6.1% mean weight loss at full dose (32/360 mg) vs. 1.3% placebo. 48% achieved ≥5% loss vs. 16% placebo. Nausea 33%, constipation 19%, headache 18%. | The Lancet 2010 ↗ |
| [2]COR-BMOD (with intensive behaviour therapy) | 9.3% mean weight loss with drug + behaviour therapy, vs. 5.1% with placebo + behaviour therapy — demonstrating additive benefit of combining drug with structured lifestyle change. | Obesity 2011 ↗ |
Reported side effects
The rates below come from the COR-I trial. View source
| Side effect | Frequency in trial |
|---|---|
| Nausea | 33% |
| Constipation | 19% |
| Headache | 18% |
| Vomiting | 11% |
| Dizziness | 10% |
| Dry mouth | 8% |
Body composition data
No specific body composition data has been published for the obesity indication. How much lean mass you keep depends largely on the protein you eat, and the exercise you do, while you are eating less.
Heart and metabolic data
The LIGHT cardiovascular outcomes trial was stopped early, because of a protocol violation. It did not give a definitive answer on heart outcomes. Slight blood pressure increases are seen, so monitoring is needed.