Clinical trial NCT01764386: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Keywords: obesity, overweight
Lead sponsor: Orexigen Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percent Change in Body Weight From Baseline (Day 1) to Week 26
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
timeFrame: Baseline to Week 26
measure: Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
timeFrame: Baseline to Week 26
measure: Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
timeFrame: Baseline to Week 26
measure: Absolute Change in Body Weight From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Waist Circumference From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Fasting Triglycerides From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Systolic Blood Pressure From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Diastolic Blood Pressure From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Heart Rate From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Fasting Plasma Glucose From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change Fasting Insulin From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26
timeFrame: Baseline to Week 26
measure: Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Saint Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Cary
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Akron
country: United States
facility: Radiant Research-Akron
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Greer
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Dallas
country: United States
facility: Radiant Research Dallas-North
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research, SLC
state: Utah
Study officials:
affiliation: Orexigen Therapeutics, Inc
name: Senior Vice President, Head of Global Development
role: STUDY_DIRECTOR
References:
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.