Phase 3
Completed N=793
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
Source: ClinicalTrials.gov NCT00456521 ↗Enrolled (actual)
793
Serious AEs
2.9%
Results posted
Nov 2014
Primary outcomePrimary: Co-primary: Body Weight- Mean Percent Change — -9.29; -5.08 percentage of body weight — p=<0.001
Summary
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-primary: Body Weight- Mean Percent Change |
-9.29; -5.08 | <0.001 sig |
| PRIMARY Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease |
66.39; 42.49 | <0.001 sig |
| SECONDARY Body Weight- Proportion of Subjects With ≥10% Decrease |
41.49; 20.21 | <0.001 sig |
| SECONDARY Change in Waist Circumference |
-9.98; -6.77 | <0.001 sig |
| SECONDARY Change in Fasting Triglycerides Levels, Using Log-transformed Data |
-16.62; -8.51 | 0.004 sig |
| SECONDARY Change in Fasting Insulin Levels, Using Log-transformed Data |
-27.98; -15.45 | 0.003 sig |
| SECONDARY Change in Fasting HDL Cholesterol Levels |
4.10; 0.87 | <0.001 sig |
| SECONDARY Change in IWQOL-Lite Total Scores |
13.43; 10.29 | 0.001 sig |
| SECONDARY Change in HOMA-IR Levels, Using Log-transformed Data |
-29.93; -16.56 | 0.003 sig |
| SECONDARY Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data |
-25.87; -16.89 | 0.165 |
| SECONDARY Change in Fasting Blood Glucose Levels |
-2.36; -1.08 | — |
| SECONDARY Change in Fasting LDL Cholesterol |
5.43; 8.13 | — |
| SECONDARY Change in Systolic Blood Pressure |
-1.32; -3.87 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-1.41; -2.78 | — |
| SECONDARY Change in IDS-SR Total Scores |
0.09; -0.00 | — |
| SECONDARY Change in Food Craving Inventory Sweets Subscale Scores |
-2.54; -2.43 | — |
| SECONDARY Change in Food Craving Inventory Carbohydrates Subscale Scores |
-2.06; -1.97 | — |
| SECONDARY Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire |
-13.75; -8.46 | — |
Eligibility Criteria
Inclusion Criteria
- Female or male subjects aged 18 to 65 years (inclusive)
- Body mass index (weight [kg]/height [m²]) ≥30 and ≤45 kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45 kg/m² for subjects with controlled hypertension and/or dyslipidemia
- Non-smoker and had not used tobacco or nicotine products for at least 6 months before screening
- Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers, beta-blockers, and clonidine. Medical regimen was to be stable for at least 8 weeks.
- Low-density lipoprotein level 450 millisecond (msec) [males] and >470 msec [females]) or the presence of any clinically significant cardiac abnormalities, including but not limited to patterns consistent with myocardial ischemia, electrolyte abnormalities, or atrial or ventricular dysrhythmia or significant conduction abnormalities
- Received excluded concomitant medications: any psychotropic agents (including antipsychotic, antidepressant, anxiolytic, mood stabilizer or anticonvulsant agents) with the exception of low-dose benzodiazepine or hypnotic agents for the treatment of insomnia; any anorectic or weight loss agents; any over-the-counter dietary supplements with psychoactive, appetite or weight effects; alpha-adrenergic blockers; beta-blockers; clonidine; coumadin; theophylline; cimetidine; oral corticosteroids; topiramate, Depo-Provera®; smoking cessation agents; regular use of opioid or opioid-like analgesics
- History of surgical or device (e.g., lap band) intervention for obesity
- History of seizures of any etiology, or of predisposition to seizures (e.g., history of cerebrovascular accident, head trauma with >5 minutes loss of consciousness, concussion symptoms lasting >15 minutes, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
- History of treatment with bupropion or naltrexone within the preceding 12 months
- History of hypersensitivity or intolerance to bupropion or naltrexone
- Used drugs, herbs, or dietary supplements believed to significantly affect body weight or participated in a weight loss management program within one month prior to baseline
- Loss or gained >4.0 kilograms within the previous 3 months
- Females who were pregnant or breast-feeding or planning to become pregnant during the study period or within 30 days of discontinuing study drug
- Planned surgical procedure that could impact the conduct of the study
- Received any investigational drug or used an experimental device or procedure within the previous 30 days
- Participated in any previous clinical trial conducted by Orexigen
- Had any condition that in the opinion of the investigator made the subject unsuitable for inclusion into the study
Data sourced from ClinicalTrials.gov (NCT00456521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.