search
Back to results

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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NB
CLI
Usual Care
Sponsored by
Orexigen Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, overweight

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research
  • Radiant Research, Inc.
  • PMG Research of Raleigh
  • PMG Research of Winston-Salem
  • PMG Research of Raleigh
  • PMG Research of Salisbury
  • PMG Research of Wilmington, LLC
  • Radiant Research-Akron
  • Radiant Research, Inc.
  • Radiant Research
  • Radiant Research, Greer
  • PMG Research of Charleston
  • PMG Research of Bristol
  • Radiant Research Dallas-North
  • Radiant Research, SLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NB + CLI

Usual Care

Arm Description

Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)

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.

Outcomes

Primary Outcome Measures

Percent Change in Body Weight From Baseline (Day 1) to Week 26

Secondary Outcome Measures

Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
Absolute Change in Body Weight From Baseline to Week 26
Change in Waist Circumference From Baseline to Week 26
Change in Fasting Triglycerides From Baseline to Week 26
Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26
Change in Heart Rate From Baseline to Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
Change Fasting Insulin From Baseline to Week 26
Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26
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
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
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
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.

Full Information

First Posted
January 4, 2013
Last Updated
November 30, 2015
Sponsor
Orexigen Therapeutics, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01764386
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orexigen Therapeutics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
obesity, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NB + CLI
Arm Type
Experimental
Arm Description
Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)
Arm Title
Usual Care
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
NB
Intervention Description
Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
Intervention Type
Behavioral
Intervention Name(s)
CLI
Intervention Description
The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual Care is a self-directed lifestyle intervention program
Primary Outcome Measure Information:
Title
Percent Change in Body Weight From Baseline (Day 1) to Week 26
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
Time Frame
Baseline to Week 26
Title
Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
Time Frame
Baseline to Week 26
Title
Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
Time Frame
Baseline to Week 26
Title
Absolute Change in Body Weight From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Waist Circumference From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Fasting Triglycerides From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Systolic Blood Pressure From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Diastolic Blood Pressure From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Heart Rate From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Fasting Plasma Glucose From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change Fasting Insulin From Baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26
Description
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.
Time Frame
Baseline to Week 26
Title
Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26
Description
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.
Time Frame
Baseline to Week 26
Title
Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26
Description
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.
Time Frame
Baseline to Week 26
Title
Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26
Description
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.
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Vice President, Head of Global Development
Organizational Affiliation
Orexigen Therapeutics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Radiant Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63151
Country
United States
Facility Name
PMG Research of Raleigh
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
PMG Research of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Radiant Research-Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Radiant Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research, Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
PMG Research of Charleston
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
PMG Research of Bristol
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Radiant Research Dallas-North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Radiant Research, SLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28026920
Citation
Halseth A, Shan K, Walsh B, Gilder K, Fujioka K. Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity. Obesity (Silver Spring). 2017 Feb;25(2):338-345. doi: 10.1002/oby.21726. Epub 2016 Dec 27.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs