{"protocolSection":{"identificationModule":{"nctId":"NCT03486392","orgStudyIdInfo":{"id":"CR108314"},"secondaryIdInfos":[{"id":"64565111OBE2001","type":"OTHER","domain":"Janssen Research & Development, LLC"},{"id":"2017-003616-39","type":"EUDRACT_NUMBER"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Janssen Research & Development, LLC","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants","officialTitle":"A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects"},"statusModule":{"statusVerifiedDate":"2020-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-03-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-03-08","type":"ACTUAL"},"completionDateStruct":{"date":"2019-03-08","type":"ACTUAL"},"studyFirstSubmitDate":"2018-03-23","studyFirstSubmitQcDate":"2018-03-30","studyFirstPostDateStruct":{"date":"2018-04-03","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-01-14","resultsFirstSubmitQcDate":"2020-01-14","resultsFirstPostDateStruct":{"date":"2020-02-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-01-14","lastUpdatePostDateStruct":{"date":"2020-02-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Janssen Research & Development, LLC","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":474,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Double-Blind: JNJ-64565111 Dose Level 1","type":"EXPERIMENTAL","description":"Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.","interventionNames":["Drug: JNJ-64565111 Dose Level 1"]},{"label":"Double-Blind: JNJ-64565111 Dose Level 2","type":"EXPERIMENTAL","description":"Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.","interventionNames":["Drug: JNJ-64565111 Dose Level 2"]},{"label":"Double-Blind: JNJ-64565111 Dose Level 3","type":"EXPERIMENTAL","description":"Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.","interventionNames":["Drug: JNJ-64565111 Dose Level 3"]},{"label":"Double-Blind: Placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.","interventionNames":["Drug: Placebo"]},{"label":"Open-Label: 3.0 milligram (mg) Liraglutide","type":"ACTIVE_COMPARATOR","description":"Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.","interventionNames":["Drug: Liraglutide"]}],"interventions":[{"type":"DRUG","name":"JNJ-64565111 Dose Level 1","description":"Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.","armGroupLabels":["Double-Blind: JNJ-64565111 Dose Level 1"]},{"type":"DRUG","name":"JNJ-64565111 Dose Level 2","description":"Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.","armGroupLabels":["Double-Blind: JNJ-64565111 Dose Level 2"]},{"type":"DRUG","name":"JNJ-64565111 Dose Level 3","description":"Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.","armGroupLabels":["Double-Blind: JNJ-64565111 Dose Level 3"]},{"type":"DRUG","name":"Liraglutide","description":"Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.","armGroupLabels":["Open-Label: 3.0 milligram (mg) Liraglutide"],"otherNames":["Saxenda"]},{"type":"DRUG","name":"Placebo","description":"Participants will receive matching placebo SC once-weekly until Week 26.","armGroupLabels":["Double-Blind: Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight at Week 26","description":"Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.","timeFrame":"Baseline, Week 26"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.","timeFrame":"Up to Week 30"}],"secondaryOutcomes":[{"measure":"Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26","description":"Number of participants with \\>= 5% body weight loss from baseline to Week 26 were reported.","timeFrame":"Week 26"},{"measure":"Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26","description":"Number of participants with \\>= 10 % body weight loss from baseline to Week 26 were reported.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Body Weight at Week 26","description":"Change from baseline in body weight at Week 26 was reported.","timeFrame":"Baseline, Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Body mass index (BMI) greater than or equal to (\\>=) 35 to less than or equal to (\\<=) 50 kilogram per square meter (kg/m\\^2) at the screening visit\n* Stable weight (that is, change of \\<= 5 percent \\[%\\] within 12 weeks before screening based on medical history)\n* Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active\n* Woman of childbearing potential have a negative pregnancy test at screening\n* Willing and able to adhere to specific the prohibitions and restrictions\n\nExclusion Criteria:\n\n* History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)\n* History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy\n* Has a Hemoglobin A1c (HbA1c) of \\>= 6.5% or fasting plasma glucose (FPG) \\>= 126 milligrams per deciliter (mg/dL) (\\>= 7.0 millimoles per liter \\[mmol/L\\]) at screening\n* Screening calcitonin of \\>= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening\n* History of glucagonoma","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Janssen Research & Development, LLC Clinical Trial","affiliation":"Janssen Research & Development, LLC","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Central Phoenix Medical Clinic","city":"Phoenix","state":"Arizona","zip":"85020","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Care Partners Clinical Research","city":"Jacksonville","state":"Florida","zip":"32277","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Advanced Clinical Research","city":"Boise","state":"Idaho","zip":"83642","country":"United States","geoPoint":{"lat":43.6135,"lon":-116.20345}},{"facility":"Medisphere Medical Research Center, Llc","city":"Evansville","state":"Indiana","zip":"47714","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}},{"facility":"L-Marc Research Center","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Milford Emergency Associates, Inc.","city":"Marlborough","state":"Massachusetts","zip":"01752","country":"United States","geoPoint":{"lat":42.34593,"lon":-71.55229}},{"facility":"Central New York Clinical Research","city":"Manlius","state":"New York","zip":"13104","country":"United States","geoPoint":{"lat":43.00201,"lon":-75.97686}},{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","zip":"10065","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Rapid Medical Research","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Omega Medical Research","city":"Warwick","state":"Rhode Island","zip":"02886","country":"United States","geoPoint":{"lat":41.7001,"lon":-71.41617}},{"facility":"Coastal Carolina Research Center","city":"Mt. 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of 474 participants were randomized out of which 444 participants completed the study.","groups":[{"id":"FG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"FG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"FG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"FG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"FG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"59"},{"groupId":"FG002","numSubjects":"118"},{"groupId":"FG003","numSubjects":"118"},{"groupId":"FG004","numSubjects":"119"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"59"},{"groupId":"FG002","numSubjects":"104"},{"groupId":"FG003","numSubjects":"109"},{"groupId":"FG004","numSubjects":"115"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"BG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"BG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"BG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"BG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"60"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"118"},{"groupId":"BG003","value":"118"},{"groupId":"BG004","value":"119"},{"groupId":"BG005","value":"474"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.9","spread":"11.84"},{"groupId":"BG001","value":"47.3","spread":"11.18"},{"groupId":"BG002","value":"46.2","spread":"11.68"},{"groupId":"BG003","value":"46.2","spread":"12.16"},{"groupId":"BG004","value":"45.6","spread":"11.71"},{"groupId":"BG005","value":"46.3","spread":"11.73"}]}]}]},{"title":"Sex: Female, 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mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent Change","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"109"},{"groupId":"OG003","value":"109"},{"groupId":"OG004","value":"108"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.76","spread":"0.73"},{"groupId":"OG001","value":"-8.51","spread":"0.76"},{"groupId":"OG002","value":"-9.83","spread":"0.56"},{"groupId":"OG003","value":"-11.80","spread":"0.58"},{"groupId":"OG004","value":"-7.54","spread":"0.54"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Dunnett's method","paramType":"Difference of least square (LS) Means","paramValue":"-6.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.31","ciUpperLimit":"-4.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.056"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Dunnett's method","paramType":"Difference of LS Means","paramValue":"-8.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.31","ciUpperLimit":"-5.84","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.921"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Dunnett's method","paramType":"Difference of LS Means","paramValue":"-10.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.31","ciUpperLimit":"-7.78","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.934"},{"groupIds":["OG000","OG004"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","statisticalMethod":"Dunnett's method","paramType":"Difference of LS Means","paramValue":"-5.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.99","ciUpperLimit":"-3.57","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.910"}]},{"type":"PRIMARY","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.","populationDescription":"Safety analysis set included all randomized participants who had received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to Week 30","groups":[{"id":"OG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"118"},{"groupId":"OG003","value":"118"},{"groupId":"OG004","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"110"},{"groupId":"OG003","value":"110"},{"groupId":"OG004","value":"96"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26","description":"Number of participants with \\>= 5% body weight loss from baseline to Week 26 were reported.","populationDescription":"mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"116"},{"groupId":"OG004","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"62"},{"groupId":"OG004","value":"56"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26","description":"Number of participants with \\>= 10 % body weight loss from baseline to Week 26 were reported.","populationDescription":"mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"116"},{"groupId":"OG003","value":"116"},{"groupId":"OG004","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"46"},{"groupId":"OG004","value":"27"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight at Week 26","description":"Change from baseline in body weight at Week 26 was reported.","populationDescription":"mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug."},{"id":"OG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"109"},{"groupId":"OG003","value":"109"},{"groupId":"OG004","value":"108"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.05","spread":"0.827"},{"groupId":"OG001","value":"-9.58","spread":"0.861"},{"groupId":"OG002","value":"-11.07","spread":"0.633"},{"groupId":"OG003","value":"-13.23","spread":"0.656"},{"groupId":"OG004","value":"-8.32","spread":"0.610"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up to 30 Weeks","description":"Safety analysis set included all randomized participants who had received at least one dose of study drug.","eventGroups":[{"id":"EG000","title":"Double Blind: Placebo","description":"Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.","deathsNumAffected":0,"deathsNumAtRisk":60,"seriousNumAffected":4,"seriousNumAtRisk":60,"otherNumAffected":33,"otherNumAtRisk":60},{"id":"EG001","title":"Double Blind: JNJ-64565111 5.0 mg","description":"Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.","deathsNumAffected":0,"deathsNumAtRisk":59,"seriousNumAffected":3,"seriousNumAtRisk":59,"otherNumAffected":43,"otherNumAtRisk":59},{"id":"EG002","title":"Double Blind: JNJ-64565111 7.4 mg","description":"Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.","deathsNumAffected":0,"deathsNumAtRisk":118,"seriousNumAffected":2,"seriousNumAtRisk":118,"otherNumAffected":106,"otherNumAtRisk":118},{"id":"EG003","title":"Double Blind: JNJ-64565111 10.0 mg","description":"Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.","deathsNumAffected":0,"deathsNumAtRisk":118,"seriousNumAffected":4,"seriousNumAtRisk":118,"otherNumAffected":104,"otherNumAtRisk":118},{"id":"EG004","title":"Open Label: Liraglutide 3.0 mg","description":"Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.","deathsNumAffected":1,"deathsNumAtRisk":119,"seriousNumAffected":4,"seriousNumAtRisk":119,"otherNumAffected":81,"otherNumAtRisk":119}],"seriousEvents":[{"term":"Myocardial Infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":1,"numAtRisk":119}]},{"term":"Stress Cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":1,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Ileus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Pancreatitis Acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":1,"numAtRisk":119}]},{"term":"Umbilical Hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":1,"numAtRisk":119}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":1,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":1,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Hyponatraemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":1,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Obesity","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Abortion Spontaneous","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":1,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]},{"term":"Major Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":1,"numAtRisk":119}]},{"term":"Menorrhagia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":0,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":0,"numAtRisk":118},{"groupId":"EG004","numAffected":0,"numAtRisk":119}]}],"otherEvents":[{"term":"Abdominal Discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":3,"numAtRisk":59},{"groupId":"EG002","numAffected":0,"numAtRisk":118},{"groupId":"EG003","numAffected":3,"numAtRisk":118},{"groupId":"EG004","numAffected":1,"numAtRisk":119}]},{"term":"Abdominal Distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":60},{"groupId":"EG001","numAffected":4,"numAtRisk":59},{"groupId":"EG002","numAffected":6,"numAtRisk":118},{"groupId":"EG003","numAffected":6,"numAtRisk":118},{"groupId":"EG004","numAffected":7,"numAtRisk":119}]},{"term":"Abdominal Pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 21.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":60},{"groupId":"EG001","numAffected":2,"numAtRisk":59},{"groupId":"EG002","numAffected":8,"numAtRisk":118},{"groupId":"EG003","numAffected":4,"numAtRisk":118},{"groupId":"EG004","numAffected":3,"numAtRisk":119}]},{"term":"Abdominal Pain Upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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