{"protocolSection":{"identificationModule":{"nctId":"NCT01764386","orgStudyIdInfo":{"id":"NB-404"},"organization":{"fullName":"Orexigen Therapeutics, Inc","class":"INDUSTRY"},"briefTitle":"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","officialTitle":"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)"},"statusModule":{"statusVerifiedDate":"2015-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-02"},"primaryCompletionDateStruct":{"date":"2014-09","type":"ACTUAL"},"completionDateStruct":{"date":"2014-09","type":"ACTUAL"},"studyFirstSubmitDate":"2013-01-04","studyFirstSubmitQcDate":"2013-01-07","studyFirstPostDateStruct":{"date":"2013-01-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-09-07","resultsFirstSubmitQcDate":"2015-10-23","resultsFirstPostDateStruct":{"date":"2015-11-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-11-30","lastUpdatePostDateStruct":{"date":"2015-12-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Orexigen Therapeutics, Inc","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"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)."},"conditionsModule":{"conditions":["Obesity","Overweight"],"keywords":["obesity, overweight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":242,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"NB + CLI","type":"EXPERIMENTAL","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)","interventionNames":["Drug: NB","Behavioral: CLI"]},{"label":"Usual Care","type":"OTHER","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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.","interventionNames":["Behavioral: Usual Care"]}],"interventions":[{"type":"DRUG","name":"NB","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)","armGroupLabels":["NB + CLI"]},{"type":"BEHAVIORAL","name":"CLI","description":"The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.","armGroupLabels":["NB + CLI"]},{"type":"BEHAVIORAL","name":"Usual Care","description":"Usual Care is a self-directed lifestyle intervention program","armGroupLabels":["Usual Care"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change in Body Weight From Baseline (Day 1) to Week 26","timeFrame":"Baseline to Week 26"}],"secondaryOutcomes":[{"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","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.","timeFrame":"Baseline to Week 26"},{"measure":"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.","timeFrame":"Baseline to Week 26"},{"measure":"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.","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","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.","timeFrame":"Baseline to Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Female or male, 18 to 60 years old\n* 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\n\nExclusion Criteria:\n\n* History of type 1 or type 2 diabetes mellitus diagnosis\n* Myocardial infarction within 6 months prior to screening\n* Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme\n* Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)\n* History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures\n* Past or planned surgical or device intervention (e.g., gastric banding) for obesity\n* Chronic use or positive screen for opioids\n* Regular use of tobacco products","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Senior Vice President, Head of Global Development","affiliation":"Orexigen Therapeutics, Inc","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Radiant Research","city":"Denver","state":"Colorado","zip":"80239","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"Radiant Research, Inc.","city":"St Louis","state":"Missouri","zip":"63151","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"PMG Research of Raleigh","city":"Cary","state":"North Carolina","zip":"27518","country":"United States","geoPoint":{"lat":35.79154,"lon":-78.78112}},{"facility":"PMG Research of Winston-Salem","city":"Hickory","state":"North Carolina","zip":"28601","country":"United States","geoPoint":{"lat":35.73319,"lon":-81.3412}},{"facility":"PMG Research of Raleigh","city":"Raleigh","state":"North Carolina","zip":"27609","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}},{"facility":"PMG Research of Salisbury","city":"Salisbury","state":"North Carolina","zip":"28144","country":"United States","geoPoint":{"lat":35.67097,"lon":-80.47423}},{"facility":"PMG Research of Wilmington, LLC","city":"Wilmington","state":"North Carolina","zip":"28401","country":"United States","geoPoint":{"lat":34.23556,"lon":-77.94604}},{"facility":"Radiant Research-Akron","city":"Akron","state":"Ohio","zip":"44311","country":"United States","geoPoint":{"lat":41.08144,"lon":-81.51901}},{"facility":"Radiant Research, Inc.","city":"Columbus","state":"Ohio","zip":"43212","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"Radiant Research","city":"Anderson","state":"South Carolina","zip":"29621","country":"United States","geoPoint":{"lat":34.50344,"lon":-82.65013}},{"facility":"Radiant Research, Greer","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"PMG Research of Charleston","city":"Mt. Pleasant","state":"South Carolina","zip":"29464","country":"United States","geoPoint":{"lat":32.79407,"lon":-79.86259}},{"facility":"PMG Research of Bristol","city":"Bristol","state":"Tennessee","zip":"37620","country":"United States","geoPoint":{"lat":36.59511,"lon":-82.18874}},{"facility":"Radiant Research Dallas-North","city":"Dallas","state":"Texas","zip":"75231","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Radiant Research, SLC","city":"Salt Lake City","state":"Utah","zip":"84107","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}}]},"referencesModule":{"references":[{"pmid":"28026920","type":"DERIVED","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."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.\n\nThe Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78)."},{"id":"FG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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.\n\nThe Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78)."}],"periods":[{"title":"Controlled Treatment Period (CTP)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"89"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Completed the 26-week Controlled Treatment Period.","numSubjects":"71"},{"groupId":"FG001","comment":"Completed the 26-week Controlled Treatment Period.","numSubjects":"82"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Wk 16 Efficacy and BP Criteria","reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Withdrawal of Consent,Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}]}]},{"title":"Uncontrolled Treatment Period (UTP)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"71"},{"groupId":"FG001","comment":"One subject completed the 26-week CTP, but did not continue in the UTP.","numSubjects":"81"}]},{"type":"Completed 52 Weeks","achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"35"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Completed the 78-week study.","numSubjects":"55"},{"groupId":"FG001","comment":"Completed the 78-week study.","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"53"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"Wk 42 Efficacy and BP Criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"26"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Withdrawal of Consent,Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Baseline analysis was based on the Intent-to-Treat (ITT) population which comprised all subjects randomized to NB + CLI who received at least 1 dose of study medication and all subjects randomly assigned to Usual Care who received their baseline lifestyle intervention program instruction.","groups":[{"id":"BG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"BG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"153"},{"groupId":"BG001","value":"89"},{"groupId":"BG002","value":"242"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.1","spread":"9.66"},{"groupId":"BG001","value":"47.0","spread":"9.98"},{"groupId":"BG002","value":"46.5","spread":"9.77"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"125"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"202"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"40"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"149"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"233"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"52"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"64"},{"groupId":"BG002","value":"188"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"153"},{"groupId":"BG001","value":"89"},{"groupId":"BG002","value":"242"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"101.4","spread":"15.09"},{"groupId":"BG001","value":"100.2","spread":"16.58"},{"groupId":"BG002","value":"100.9","spread":"15.63"}]}]}]},{"title":"Baseline BMI","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.33","spread":"4.200"},{"groupId":"BG001","value":"36.26","spread":"4.369"},{"groupId":"BG002","value":"36.31","spread":"4.254"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percent Change in Body Weight From Baseline (Day 1) to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change in body weight","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.46","spread":"0.54"},{"groupId":"OG001","value":"-0.94","spread":"0.49"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-8.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.88","ciUpperLimit":"-7.15"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"84.5"},{"groupId":"OG001","value":"12.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"44.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"16.6","ciUpperLimit":"116.3"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.3"},{"groupId":"OG001","value":"3.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"21.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.0","ciUpperLimit":"76.7"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.7"},{"groupId":"OG001","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Absolute Change in Body Weight From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"0.56"},{"groupId":"OG001","value":"-1.0","spread":"0.51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-8.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.07","ciUpperLimit":"-7.24"}]},{"type":"SECONDARY","title":"Change in Waist Circumference From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"cm","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.96","spread":"0.705"},{"groupId":"OG001","value":"-1.64","spread":"0.659"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-5.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.14","ciUpperLimit":"-3.50"}]},{"type":"SECONDARY","title":"Change in Fasting Triglycerides From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.6","spread":"4.96"},{"groupId":"OG001","value":"2.8","spread":"4.63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0019","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-16.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-29.5","ciUpperLimit":"-3.3"}]},{"type":"SECONDARY","title":"Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"2.20"},{"groupId":"OG001","value":"-1.9","spread":"2.11"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9686","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.96","ciUpperLimit":"5.73"}]},{"type":"SECONDARY","title":"Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1","spread":"0.77"},{"groupId":"OG001","value":"0.1","spread":"0.73"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"4.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.99","ciUpperLimit":"6.06"}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm Hg","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.8","spread":"1.10"},{"groupId":"OG001","value":"-2.8","spread":"1.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1706","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-2.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.9","ciUpperLimit":"0.9"}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mm Hg","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"0.83"},{"groupId":"OG001","value":"-1.3","spread":"0.77"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7160","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.6","ciUpperLimit":"1.8"}]},{"type":"SECONDARY","title":"Change in Heart Rate From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"bpm","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"0.88"},{"groupId":"OG001","value":"-0.3","spread":"0.82"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0913","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"4.3"}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"1.04"},{"groupId":"OG001","value":"1.6","spread":"0.96"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0016","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-4.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.2","ciUpperLimit":"-1.7"}]},{"type":"SECONDARY","title":"Change Fasting Insulin From Baseline to Week 26","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"uIU/mL","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.5","spread":"0.79"},{"groupId":"OG001","value":"-3.4","spread":"0.76"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0004","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-4.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.2","ciUpperLimit":"-2.0"}]},{"type":"SECONDARY","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.","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"0.20"},{"groupId":"OG001","value":"-0.8","spread":"0.19"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0003","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.7","ciUpperLimit":"-0.7"}]},{"type":"SECONDARY","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.","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.8","spread":"0.72"},{"groupId":"OG001","value":"1.1","spread":"0.67"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-7.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.8","ciUpperLimit":"-6.0"}]},{"type":"SECONDARY","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.","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"0.36"},{"groupId":"OG001","value":"-0.1","spread":"0.34"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-2.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.1","ciUpperLimit":"-1.1"}]},{"type":"SECONDARY","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.","populationDescription":"The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline \\[BL\\] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline to Week 26","groups":[{"id":"OG000","title":"NB + CLI","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."},{"id":"OG001","title":"Usual Care","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"82"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.4","spread":"1.50"},{"groupId":"OG001","value":"-1.0","spread":"1.41"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"17.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"13.45","ciUpperLimit":"21.36"}]}]},"adverseEventsModule":{"frequencyThreshold":"1","timeFrame":"Day 1 through Week 78","description":"Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study.\n\nThe 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.","eventGroups":[{"id":"EG000","title":"NB + CLI (Controlled Treatment Period)","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.\n\nThe Controlled Treatment Period was from Day 1 to Week 26.","seriousNumAffected":1,"seriousNumAtRisk":153,"otherNumAffected":26,"otherNumAtRisk":153},{"id":"EG001","title":"Usual Care (Controlled Treatment Period)","description":"Usual Care (self-directed lifestyle intervention)\n\nUsual 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.\n\nThe Controlled Treatment Period was from Day 1 to Week 26.","seriousNumAffected":0,"seriousNumAtRisk":89,"otherNumAffected":0,"otherNumAtRisk":89},{"id":"EG002","title":"All Subjects (Entire Study)","description":"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)\n\nNB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)\n\nCLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.\n\nAll Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study.","seriousNumAffected":2,"seriousNumAtRisk":242,"otherNumAffected":32,"otherNumAtRisk":242}],"seriousEvents":[{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One subject experienced an SAE during the Uncontrolled Treatment Period.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":242}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":16,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":17,"numAffected":17,"numAtRisk":242}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":242}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":242}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":242}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":242}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v.15.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":153},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":89},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":242}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"If not already published by Sponsor as part of a multi-center publication, 24 months after conclusion, abandonment or termination of the study or notification that there will be no such multi-center publication, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 90 days to review and comment on the proposed publication. Sponsor may delay publication for up to an additional 6 month period to file for patent protection."},"pointOfContact":{"title":"Executive Vice President, Head of Global Development","organization":"Orexigen Therapeutics, Inc.","email":"MedInfo@Orexigen.com","phone":"(858) 875-8600"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D050177","term":"Overweight"}],"ancestors":[{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]}},"hasResults":true}