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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01764386
First received: January 4, 2013
Last updated: November 30, 2015
Last verified: November 2015

January 4, 2013
November 30, 2015
February 2013
September 2014   (final data collection date for primary outcome measure)
Percent Change in Body Weight From Baseline (Day 1) to Week 26 [ Time Frame: Baseline to Week 26 ] [ 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 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01764386 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Absolute Change in Body Weight From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Waist Circumference From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting Triglycerides From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Heart Rate From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change Fasting Insulin From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.
  • Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.
  • Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.
  • Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.
  • 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 ]
Not Provided
  • 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 ]
 
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. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. 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)

    Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.

    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.
 
Completed
242
September 2014
September 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
Not Provided
Not Provided
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
Study Director: Senior Vice President, Head of Global Development Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
November 2015

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