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Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01764386
First received: January 4, 2013
Last updated: September 4, 2014
Last verified: September 2014

January 4, 2013
September 4, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
To assess effect of intended clinical method of use 32 mg naltrexone SR/360 mg bupropion SR in conjunction with a comprehensive lifestyle intervention (CLI) compared to Usual Care (minimal lifestyle intervention program) on percent change in body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01764386 on ClinicalTrials.gov Archive Site
  • To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 5% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on the absolute change in body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including waist circumference [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in systolic blood pressure [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting glucose [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including eating behavior [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 10% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 15% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting triglycerides [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting LDL cholesterol [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: Yes ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting HDL cholesterol [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in diastolic blood pressure [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in heart rate [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting insulin [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including homeostasis model assessment - insulin resistance (HOMA-IR) [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including sexual function [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including weight related quality of life [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
Same as current
  • To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 5% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 10% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 15% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess effect of intended clinical method of use 32 mg naltrexone SR/360 mg bupropion SR in conjunction with a comprehensive lifestyle intervention (CLI) compared to Usual Care (minimal lifestyle intervention program) on percent change in body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on the absolute change in body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including waist circumference [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting triglycerides [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting LDL cholesterol [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting HDL cholesterol [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in systolic blood pressure [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in diastolic blood pressure [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in heart rate [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting glucose [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting insulin [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including homeostasis model assessment - insulin resistance (HOMA-IR) [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including eating behavior [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including sexual function [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
  • To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including weight-related quality of life [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
Same as current
 
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
A Multicenter, Randomized, Open-Label, Controlled, Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects (The Ignite Study)

The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Drug: NB
    Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
  • Behavioral: CLI
    The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.
  • Behavioral: Usual Care
    Usual Care is a self-directed lifestyle intervention program
  • Experimental: NB + CLI
    Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)
    Interventions:
    • Drug: NB
    • Behavioral: CLI
  • Usual Care
    Usual care (self-directed lifestyle intervention)
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female or male, 18 to 60 years old
  • Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity, or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled hypertension

Exclusion Criteria:

  • History of type 1 or type 2 diabetes mellitus diagnosis
  • Myocardial infarction within 6 months prior to screening
  • Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
  • Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)
  • History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures
  • Past or planned surgical or device intervention (e.g., gastric banding) for obesity
  • Chronic use or positive screen for opioids
  • Regular use of tobacco products
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01764386
NB-404
No
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
Study Director: Senior Vice President, Head of Global Development Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
September 2014

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