A Study of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00532779
First received: September 19, 2007
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.


Condition Intervention Phase
Obesity
Overweight
Drug: NB16 (Naltrexone SR 16 mg/bupropion SR 360 mg/day)
Drug: NB32 (Naltrexone SR 32 mg/bupropion SR 360 mg/day)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Overweight and Obese Subjects

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Co-primary outcome measures are the percentage of total body weight lost and the percentage of subjects who achieve a weight decrease of ≥ 5%. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving ≥10% weight loss; Waist circumference; Fasting triglyceride, HDL cholesterol, insulin and glucose [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Enrollment: 1742
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB16
Naltrexone SR 16 mg/Bupropion SR 360 mg /day
Drug: NB16 (Naltrexone SR 16 mg/bupropion SR 360 mg/day)
Naltrexone SR 16 mg/bupropion SR 360 mg/day
Experimental: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg /day
Drug: NB32 (Naltrexone SR 32 mg/bupropion SR 360 mg/day)
Naltrexone SR 32 mg/bupropion SR 360 mg/day
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Detailed Description:

Two Phase II clinical trials have demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study will investigate the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with obesity and hypertension and/or dyslipidemia.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male subjects, 18 to 65 years of age
  • Have body mass index (BMI) of 30 to 45 kg/m2 for subjects with uncomplicated obesity, and BMI of 27 to 45 kg/m2 for subjects with obesity and controlled hypertension and/or dyslipidemia
  • Normotensive (systolic BP < or = 140 mm Hg; diastolic < or = 90 mm Hg). Anti-hypertensive medications are allowed with the exception of alpha-adrenergic blockers and clonidine. Medical regimen must be stable for at least 6 weeks prior to randomization
  • Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks prior to randomization
  • Free of opioid medication for 7 days prior to randomization
  • No clinically significant abnormality of serum albumin, blood urea nitrogen, creatinine, bilirubin, sodium, potassium, chloride, calcium or phosphorus
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 x upper limit of normal
  • No clinically significant abnormality of hematocrit, white blood cell count, white cell differential, or platelets
  • Fasting glucose < 126 mg/dL on no hypoglycemic agents, fasting triglycerides < 400 mg/dL
  • No clinically significant abnormality on urinalysis
  • Thyroid stimulating hormone (TSH) within normal limits or normal T3, if TSH is below normal limits
  • Negative serum pregnancy test in women of child bearing potential
  • Negative urine drug screen
  • Inventory of Depressive Symptoms-Subject Rated(IDS-SR) scores <2 on items 5 (sadness), 6 (irritability), 7 (anxiety/tension) and 18 (suicidality) and IDS-SR total score <30
  • If woman of child bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
  • Able to comply with all required study procedures and schedule
  • Able to speak and read English
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Obesity if unknown endocrine origin
  • Serious medical condition
  • History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer
  • A lifetime history a serious psychiatric illness
  • Current serious psychiatric illness
  • A response to bipolar disorder questions indicating presence of bipolar disorder
  • In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization
  • History of drug or alcohol abuse or dependence (with the exception of nicotine dependence) within 1 year prior to study participation
  • Type 1 or Type 2 diabetes mellitus
  • Screening ECG with QTcB >450 msec (men) or >470 msec (women) or the presence of any clinically significant cardiac abnormalities
  • On prohibited concomitant medications
  • History of surgical or device (e.g. gastric banding) intervention for obesity
  • History of seizures of any etiology, or of predisposition to seizures
  • History of treatment with bupropion, or naltrexone within the preceding 12 months
  • History of hypersensitivity or intolerance to bupropion or naltrexone
  • Initiation or discontinuation of tobacco products; Use of nicotine replacement products (nicotine gum, patch etc) during this period is excluded
  • Use of drugs, herbs, or dietary supplements believed to significantly affect body weight or participation in a weight loss management program within one month prior to randomization
  • Loss or gain of more than 4.0 kilograms within 3 months prior to randomization
  • Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug
  • Use of investigational drug, device or procedure in the previous 30 days
  • Participation in any previous clinical trial sponsored by Orexigen Therapeutics
  • Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study
  • Investigators, study personnel, sponsor representatives and their immediate families
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532779

  Show 34 Study Locations
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center, Baton Rouge, Louisiana
  More Information

Publications:
Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00532779     History of Changes
Other Study ID Numbers: NB-301, COR-I
Study First Received: September 19, 2007
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Obesity
Antiobesity agents
Antiobesity drugs
Overweight drug therapy
Obese drug therapy
Weight loss drug effects
Bupropion administration and dosage
Naltrexone administration and dosage
Double blind method
Combination drug therapy
Delayed action preparations

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms
Bupropion
Naltrexone
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014