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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00456521
First received: April 3, 2007
Last updated: October 30, 2012
Last verified: October 2012

April 3, 2007
October 30, 2012
March 2007
December 2008   (final data collection date for primary outcome measure)
  • Change in Body Weight [ Time Frame: Baseline, 56 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve a Weight Decrease of ≥5% [ Time Frame: Baseline, 56 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 56 in percentage of total body weight lost
Complete list of historical versions of study NCT00456521 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve a Weight Decrease of ≥10% [ Time Frame: Baseline, 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who lose at least 5% and 10% of their baseline body weight
  • Effects on mood from baseline to week 56 as measured by the IDS-SR
  • Effect on selected obesity-associated cardiovascular risk factors, including serum triglycerides, HDL and LDL cholesterol, waist circumference, glucose and insulin levels, HOMA-IR, hs-CRP levels and vital signs.
  • Effects on quality of life from baseline to week 56 as measured by the IWQOL- Lite
Not Provided
Not Provided
 
A Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in a Behavior Modification Program
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Drug: naltrexone SR/bupropionSR combination
    naltrexone SR 32 mg/bupropion SR 360 mg per day
  • Behavioral: Intensive group lifestyle modification counseling
    Group lifestyle modification counseling
  • Drug: PBO
    Other Name: placebo
  • Experimental: NB32
    Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling
    Interventions:
    • Drug: naltrexone SR/bupropionSR combination
    • Behavioral: Intensive group lifestyle modification counseling
  • Placebo Comparator: PBO
    placebo with intensive group behavioral lifestyle modification counseling
    Interventions:
    • Behavioral: Intensive group lifestyle modification counseling
    • Drug: PBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
793
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00456521
NB-302, COR-BMOD
Yes
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center, Baton Rouge, Louisiana
Orexigen Therapeutics, Inc
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP