{"protocolSection":{"identificationModule":{"nctId":"NCT00781937","orgStudyIdInfo":{"id":"NN8022-1923"},"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance","officialTitle":"Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period"},"statusModule":{"statusVerifiedDate":"2017-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-10-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2010-09-01","type":"ACTUAL"},"completionDateStruct":{"date":"2010-09-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-10-28","studyFirstSubmitQcDate":"2008-10-28","studyFirstPostDateStruct":{"date":"2008-10-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-09-01","resultsFirstSubmitQcDate":"2011-10-20","resultsFirstPostDateStruct":{"date":"2011-11-28","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-09-29","lastUpdatePostDateStruct":{"date":"2017-11-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).\n\nTrial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68)."},"conditionsModule":{"conditions":["Metabolism and Nutrition Disorder","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":422,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lira 3.0 mg","type":"EXPERIMENTAL","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached","interventionNames":["Drug: liraglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily","armGroupLabels":["Lira 3.0 mg"]},{"type":"DRUG","name":"placebo","description":"Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Percentage Change in Fasting Body Weight From Baseline","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0","description":"Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"}],"secondaryOutcomes":[{"measure":"Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Fasting Weight","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period","description":"Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 68"},{"measure":"Change From Baseline in Blood Pressure","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Pulse","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Fasting Lipid Profile: Triglycerides","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Fasting Lipid Profile: Total Cholesterol","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)","timeFrame":"Week 0, week 56"},{"measure":"Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56","description":"Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides \\>1.7mmol/L; High density lipoprotein cholesterol (men \\<0.9mmol/L, women \\<1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.","timeFrame":"Week 56"},{"measure":"Change From Baseline in Waist Circumference","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Body Mass Index (BMI)","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)","description":"Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated \\[X% - Y%\\]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \\<35 years have median beta-cell function indexed at 100%.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)","description":"Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated \\[X - Y\\]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \\<35 years have median insulin resistance indexed at 1.00.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","timeFrame":"Week 0, week 56"},{"measure":"Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)","description":"Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated \\[X% - Y%\\].","timeFrame":"Week 0, week 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weight\n\nExclusion Criteria:\n\n* Diagnosis of type 1 or type 2 diabetes\n* Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months\n* Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L\n* History of chronic pancreatitis or idiopathic acute pancreatitis\n* Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)\n* Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial\n* Current participation in an organized diet reduction program (or within the last 3 months)\n* Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin\n* Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)\n* History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder\n* Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Goodyear","state":"Arizona","zip":"85395","country":"United States","geoPoint":{"lat":33.43532,"lon":-112.35821}},{"facility":"Novo Nordisk Investigational Site","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Novo Nordisk Investigational Site","city":"Huntington 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EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2."},{"pmid":"27817208","type":"RESULT","citation":"Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6."},{"pmid":"23812094","type":"RESULT","citation":"Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013 Nov;37(11):1443-51. doi: 10.1038/ijo.2013.120. Epub 2013 Jul 1."},{"pmid":"26418188","type":"RESULT","citation":"McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814."},{"pmid":"28473337","type":"RESULT","citation":"Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4."},{"pmid":"28386912","type":"RESULT","citation":"O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21."},{"pmid":"28950422","type":"RESULT","citation":"Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects who lost at least 5% of screening body weight after 4 weeks and up to 12 weeks during the run-in were randomised in a 1:1 manner to receive either liraglutide 3.0 mg, or placebo for 56 weeks.","recruitmentDetails":"The trial was conducted at 26 sites in the United States and 10 sites in Canada.","groups":[{"id":"FG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached"},{"id":"FG001","title":"Placebo","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period"}],"periods":[{"title":"Main Trial Period Through Week 56","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"212"},{"groupId":"FG001","numSubjects":"210"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"146"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"64"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"15"}]}]},{"title":"Follow up Period (Week 56-68)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"146"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"141"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached"},{"id":"BG001","title":"Placebo","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.9","spread":"11.9"},{"groupId":"BG001","value":"46.5","spread":"11.0"},{"groupId":"BG002","value":"46.2","spread":"11.5"}]}]}]},{"title":"Sex: Female, 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(NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"56"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"170"},{"groupId":"BG001","value":"185"},{"groupId":"BG002","value":"355"}]},{"title":"More than one 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Subjects discontinued treatment in the 12-week follow-up period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"206"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.12","spread":"0.68"},{"groupId":"OG001","value":"3.15","spread":"0.65"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1968","pValueComment":"Two sided, conducted at a 5% significance level","statisticalMethod":"ANCOVA","statisticalComment":"The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.","paramType":"Treatment Contrast","paramValue":"0.97","ciPctValue":"95","ciLowerLimit":"-0.51","ciUpperLimit":"2.45"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: Triglycerides","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","populationDescription":"Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. 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Subjects discontinued treatment in the 12-week follow-up period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"187"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"0.04"},{"groupId":"OG001","value":"0.12","spread":"0.04"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0310","pValueComment":"Two sided, conducted at a 5% significance level","statisticalMethod":"ANCOVA","statisticalComment":"The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.","paramType":"Treatment Contrast","paramValue":"-0.11","ciPctValue":"95","ciLowerLimit":"-0.20","ciUpperLimit":"-0.01"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","populationDescription":"Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. 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Subjects discontinued treatment in the 12-week follow-up period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"187"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.24","spread":"0.05"},{"groupId":"OG001","value":"0.33","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1098","pValueComment":"Two sided, conducted at a 5% significance level","statisticalMethod":"ANCOVA","statisticalComment":"The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.","paramType":"Treatment Contrast","paramValue":"-0.09","ciPctValue":"95","ciLowerLimit":"-0.20","ciUpperLimit":"0.02"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Lipid Profile: Total Cholesterol","description":"Subjects were tested having fasted (consumed only water) since midnight the night before the visit.","populationDescription":"Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. 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Subjects discontinued treatment in the 12-week follow-up period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"187"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.22","spread":"0.06"},{"groupId":"OG001","value":"0.33","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1149","pValueComment":"Two sided, conducted at a 5% significance level","statisticalMethod":"ANCOVA","statisticalComment":"The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.","paramType":"Treatment Contrast","paramValue":"-0.11","ciPctValue":"95","ciLowerLimit":"-0.24","ciUpperLimit":"0.03"}]},{"type":"SECONDARY","title":"Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)","populationDescription":"Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"nmol/L","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. 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Subjects discontinued treatment in the 12-week follow-up period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"206"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.36","spread":"0.62"},{"groupId":"OG001","value":"-0.86","spread":"0.59"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Two sided, conducted at a 5% significance level","statisticalMethod":"ANCOVA","statisticalComment":"The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.","paramType":"Treatment Contrast","paramValue":"-3.50","ciPctValue":"95","ciLowerLimit":"-4.84","ciUpperLimit":"-2.15"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI)","populationDescription":"Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg/m^2","timeFrame":"Week 0, week 56","groups":[{"id":"OG000","title":"Lira 3.0 mg","description":"A 12-week run-in period where screened subjects were treated with a low calorie diet. 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