A Study of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects Participating in a Behavior Modification Program

Official Title: “A Phase 3 Study Comparing the Safety and Efficacy of Naltrexone SR/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program”

The purpose of this study is to determine whether a combination of 2 drugs 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.

The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg. Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study will evaluate weight loss in subjects participating in such a comprehensive program who receive a combination of naltrexone SR and bupropion SR or placebo.

Intervention(s) in this Clinical Trial

• Drug: naltrexone SR/bupropionSR combination
  • naltrexone SR 32 mg/bupropion SR 360 mg per day
• Behavioral: Group lifestyle modification counseling
  • Group lifestyle modification counseling

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Group 1
• Placebo Comparator: Group 2

Primary Measures

• Change in percentage of total body weight lost
  • Time Frame: Baseline to week 56
    Safety Issue?: No

Secondary Measures

• Effect on selected obesity-associated cardiovascular risk factors, including serum triglycerides, HDL and LDL cholesterol, waist circumference, glucose and insulin levels.
  • Time Frame: Baseline to week 56
    Safety Issue?: No
• Proportion of subjects who lose at least 5% and 10% of their baseline body weight
  • Time Frame: Baseline to week 56
    Safety Issue?: No

Inclusion Criteria:

• Female and male subjects, 18 to 65 years of age
• Have body mass index (BMI) between 30 and 45kg/m2 for subjects with uncomplicated obesity, and 27 and 45kg/m2 for subjects with obesity and controlled hypertension and/or dyslipidemia
• Non-smoker and no use of tobacco or nicotine products for at least 6 months
• Normotensive(< 140/90 mm Hg), some anti-hypertensive medications are allowed
• LDL cholesterol < 190 mg/dL and triglycerides < 400 mg/dL
• Women of child bearing potential must have negative serum pregnancy, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after stopping study drug

Exclusion Criteria:

• Obesity of known endocrine origin such as untreated hypothyroidism or Polycystic
• Ovary Syndrome
• Serious medical condition
• Serious psychiatric illness
• Type I or Type II diabetes mellitus
• Need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
• On prohibited concomitant medication
• History of surgical or device (e.g. lap band) intervention for obesity
• History of seizures or predisposition to seizures

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Orexigen Therapeutics, Inc Industry

Overall Clinical Trial Officials and Contacts

Frank Greenway, MD Principal Investigator Pennington Biomedical Research Center, Baton Rouge, Louisiana  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00456521

Study ID Number: NB-302

ClinicalTrials.gov Identifier: NCT00456521

Health Authority: United States: Food and Drug Administration