{"protocolSection":{"identificationModule":{"nctId":"NCT04102189","orgStudyIdInfo":{"id":"NN9536-4451"},"secondaryIdInfos":[{"id":"U1111-1215-7560","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2018-002431-18","type":"EUDRACT_NUMBER"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity","officialTitle":"Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity"},"statusModule":{"statusVerifiedDate":"2025-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-03-25","type":"ACTUAL"},"completionDateStruct":{"date":"2022-03-28","type":"ACTUAL"},"studyFirstSubmitDate":"2019-09-23","studyFirstSubmitQcDate":"2019-09-23","studyFirstPostDateStruct":{"date":"2019-09-25","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-03-24","resultsFirstSubmitQcDate":"2023-03-24","resultsFirstPostDateStruct":{"date":"2023-04-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-03","lastUpdatePostDateStruct":{"date":"2025-12-11","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking \"dummy\" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or \"dummy\" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start."},"conditionsModule":{"conditions":["Overweight","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":201,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo injected s.c. once weekly .","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks","armGroupLabels":["Semaglutide"]},{"type":"OTHER","name":"Placebo","description":"Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Mass Index (BMI) (Percentage [%])","description":"Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 5% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 5% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 5% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","timeFrame":"At week 68"},{"measure":"Change in Body Weight (Kilograms [kg])","description":"Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Body Weight (%)","description":"Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 10% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","timeFrame":"At week 68"},{"measure":"Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 15% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","timeFrame":"At week 68"},{"measure":"Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 20% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","timeFrame":"At week 68"},{"measure":"Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])","description":"Change from baseline in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) at week 68 is presented. CDC gender and age-specific growth charts: normal (BMI less than \\[\\<\\] 85th percentile), overweight (BMI greater than or equal to \\[\\>=\\] 85th - \\<95th percentile), obesity class I (BMI \\>=95th - \\<120% of the 95th percentile), obesity class II (BMI \\>=120% of the 95th percentile - \\<140% of the 95th percentile) and obesity class III (BMI \\>=140% of the 95th percentile). Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage of Participants Achieving Improvement in Weight Category (Yes/no)","description":"Percentage of participants who achieved improvement in weight category from baseline (week 0) to week 68 is presented. Improvement in weight category was defined as being in a lower weight category at week 68 compared to baseline according to CDC gender and age-specific growth charts: normal (BMI \\<85th percentile), overweight (BMI \\>=85th - \\<95th percentile), obesity class I (BMI \\>=95th - \\<120% of the 95th percentile), obesity class II (BMI \\>=120% of the 95th percentile - \\<140% of the 95th percentile) and obesity class III (BMI \\>=140% of the 95th percentile). In the reported data, 'Yes' infers the percentage of participants who have achieved improvement in weight category, whereas 'No' infers the percentage of participants who did not achieve improvement in weight category. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.","timeFrame":"At week 68"},{"measure":"Change in BMI (Standard Deviation Score [SDS])","description":"Change in BMI SDS from baseline to week 68 is presented. The SDS scores are also called as z-scores. BMI SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Possible values range from -3 to +3, a negative score being beneficial. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in BMI (Kilograms Per Meter Square [kg/m^2])","description":"Change in BMI (kg/m\\^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference (centimeters \\[cm\\]) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)","description":"Percentage of participants who achieved \\>= 5% reduction of BMI from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 5% BMI reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 5% BMI reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","timeFrame":"At week 68"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Glycated Haemoglobin (HbA1c) (%)","description":"Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in HbA1c (Millimoles Per Mole [mmol/Mol])","description":"Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])","description":"Change in fasting plasma glucose (mmol/L) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])","description":"Change in fasting plasma glucose (mg/dL) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline","description":"Change in fasting insulin (pmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline","description":"Change in fasting insulin (mIU/mL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Total Cholesterol (mmol/L): Ratio to Baseline","description":"Change in total cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Total Cholesterol (mg/dL): Ratio to Baseline","description":"Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline","description":"Change in HDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68:"},{"measure":"Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline","description":"Change in HDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline","description":"Change in LDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in LDL Cholesterol (mg/dL): Ratio to Baseline","description":"Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68:"},{"measure":"Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline","description":"Change in VLDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in VLDL Cholesterol (mg/dL): Ratio to Baseline","description":"Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Triglycerides (mmol/L): Ratio to Baseline","description":"Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Triglycerides (mg/dL): Ratio to Baseline","description":"Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Alanine Aminotransferase (ALT): Ratio to Baseline","description":"Change in ALT (units per liter \\[U/L\\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","timeFrame":"Baseline (week 0), week 68"},{"measure":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as greater than (\\>) 7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","timeFrame":"From baseline (week 0) to week 75"},{"measure":"Number of Treatment-emergent Serious Adverse Events (SAEs)","description":"An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","timeFrame":"From baseline (week 0) to week 75"},{"measure":"Change in Pulse","description":"Change in pulse from baseline to week 68 is presented. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Amylase: Ratio to Baseline","description":"Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Lipase: Ratio to Baseline","description":"Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"Baseline (week 0), week 68"},{"measure":"Change in Calcitonin: Ratio to Baseline","description":"Change in calcitonin (nanograms per liter \\[ng/L\\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"Baseline (week 0), week 68"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male or female, ages 12 to below 18 years at the time of signing informed consent\n* BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes\n* History of at least one self-reported unsuccessful dietary effort to lose weight\n\nFor subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:\n\n\\- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening\n\nExclusion Criteria:\n\n* Prepubertal subjects (Tanner stage 1)\n* History of type 1 diabetes\n* A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)\n* For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Children's Hospital Los Angeles - Endocrinology","city":"Los Angeles","state":"California","zip":"90027","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Solaris Clinical Research","city":"Meridian","state":"Idaho","zip":"83646","country":"United States","geoPoint":{"lat":43.61211,"lon":-116.39151}},{"facility":"Pennington Biomed Res Ctr","city":"Baton Rouge","state":"Louisiana","zip":"70808-4124","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"DelRicht Research","city":"Gretna","state":"Louisiana","zip":"70053","country":"United States","geoPoint":{"lat":29.91465,"lon":-90.05396}},{"facility":"Barry J. Reiner, MD LLC","city":"Baltimore","state":"Maryland","zip":"21229","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Massachusetts General Hospital_Cary","city":"Boston","state":"Massachusetts","zip":"02114-2621","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"University of Minnesota_CPOM","city":"Minneapolis","state":"Minnesota","zip":"55414","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"University of Minnesota_Minneapolis","city":"Minneapolis","state":"Minnesota","zip":"55455","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"UBMD Peds-Div of Endo/Diabetes","city":"Buffalo","state":"New York","zip":"14203","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}},{"facility":"WakeMed Childn Endo-Dbt_Raleig","city":"Raleigh","state":"North Carolina","zip":"27610","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}},{"facility":"Valley Weight Loss Clinic","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Aventiv Research Inc","city":"Columbus","state":"Ohio","zip":"43213","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"PriMed Clinical Research","city":"Dayton","state":"Ohio","zip":"45419","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"Geisinger Clinic","city":"Danville","state":"Pennsylvania","zip":"17822-2111","country":"United States","geoPoint":{"lat":40.96342,"lon":-76.61273}},{"facility":"Children's Hosptl Philadelphia","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"UPMC Child Hosp-Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","zip":"15224","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Medical Research South, LLC_Cary","city":"Goose Creek","state":"South Carolina","zip":"29445","country":"United States","geoPoint":{"lat":32.98101,"lon":-80.03259}},{"facility":"Greenville Hospital System Pediatric Endo","city":"Greenville","state":"South Carolina","zip":"29615","country":"United States","geoPoint":{"lat":34.85262,"lon":-82.39401}},{"facility":"Monument Health Clinical Rsrch","city":"Rapid City","state":"South Dakota","zip":"57701","country":"United States","geoPoint":{"lat":44.08054,"lon":-103.23101}},{"facility":"Discovery MM Services, Inc","city":"Houston","state":"Texas","zip":"77061","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Univ Of Texas Hlth Science Cntr","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"National Clin Res Inc.","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Marshfield Clinic","city":"Marshfield","state":"Wisconsin","zip":"54449","country":"United States","geoPoint":{"lat":44.66885,"lon":-90.1718}},{"facility":"Fließer-Görzer [Ordination]","city":"Saint Stefan","zip":"8511","country":"Austria"},{"facility":"Universitätsklinik für Kinder und Jugendheilkunde Haus E","city":"Salzburg","zip":"5020","country":"Austria","geoPoint":{"lat":47.79941,"lon":13.04399}},{"facility":"Ordination Dr. Hanusch","city":"Vienna","zip":"1060","country":"Austria","geoPoint":{"lat":48.20849,"lon":16.37208}},{"facility":"UZ Brussel","city":"Brussels","zip":"1090","country":"Belgium","geoPoint":{"lat":50.85045,"lon":4.34878}},{"facility":"Cliniques Universitaires Saint-Luc - Serv. 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Raukhfus","city":"Saint Petersburg","zip":"191036","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"facility":"SPSBHI City Children out-patient clinic #44","city":"Saint Petersburg","zip":"191144","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"facility":"Siberian State Medical University","city":"Tomsk","zip":"634050","country":"Russia","geoPoint":{"lat":56.50049,"lon":84.98216}},{"facility":"Clifton Medical Centre","city":"Rotherham","state":"South Yorkshire","zip":"S65 1DA","country":"United Kingdom","geoPoint":{"lat":53.43012,"lon":-1.35678}},{"facility":"Birmingham Children's Hospital","city":"Birmingham","zip":"B4 6NH","country":"United Kingdom","geoPoint":{"lat":52.48142,"lon":-1.89983}},{"facility":"University Hospitals Bristol & Weston NHS Foundation Trust","city":"Bristol","zip":"BS2 8AE","country":"United Kingdom","geoPoint":{"lat":51.45523,"lon":-2.59665}},{"facility":"University College Hospital Hospital - Paediatric Services","city":"London","zip":"WC1E 6DB","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"Ecclesfield Group Practice","city":"Sheffield","zip":"S35 9XQ","country":"United Kingdom","geoPoint":{"lat":53.38297,"lon":-1.4659}},{"facility":"Southampton General Hospital","city":"Southampton","zip":"SO16 6YD","country":"United Kingdom","geoPoint":{"lat":50.90395,"lon":-1.40428}}]},"referencesModule":{"references":[{"pmid":"36322838","type":"RESULT","citation":"Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2."},{"pmid":"37196421","type":"DERIVED","citation":"Kelly AS, Arslanian S, Hesse D, Iversen AT, Korner A, Schmidt S, Sorrig R, Weghuber D, Jastreboff AM. Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg. Obesity (Silver Spring). 2023 Aug;31(8):2139-2149. doi: 10.1002/oby.23808. Epub 2023 Jul 9."},{"pmid":"36534451","type":"DERIVED","citation":"Weghuber D, Boberg K, Hesse D, Jeppesen OK, Sorrig R, Kelly AS; STEP TEENS Investigators. Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study. J Comp Eff Res. 2023 Feb;12(2):e220187. doi: 10.2217/cer-2022-0187. Epub 2022 Dec 19."},{"pmid":"35797460","type":"DERIVED","citation":"Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized 2:1 to receive either semaglutide subcutaneously (s.c.) once weekly or semaglutide placebo s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks. This was followed by a 7-week follow-up period after 'end of treatment' due to the long half-life of semaglutide.","recruitmentDetails":"The trial was conducted at 37 sites in 8 countries, as follows: Austria (3), Belgium (4), Croatia (3), Ireland (1), Mexico (1), Russia (7), Great Britain (6), United States (12).","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"FG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"67"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"67"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"67"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"67"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"64"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by parent/guardian","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set (FAS) included all randomized participants according to the intention-to-treat principle.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"BG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"134"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"201"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.5","spread":"1.5"},{"groupId":"BG001","value":"15.3","spread":"1.6"},{"groupId":"BG002","value":"15.4","spread":"1.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"84"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"125"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"76"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"22"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"179"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"159"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"20"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"16"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Mass Index (BMI) (Percentage [%])","description":"Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"The full analysis set (FAS) included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change of BMI","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.2","spread":"12.9"},{"groupId":"OG001","value":"-0.1","spread":"8.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-16.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-20.27","ciUpperLimit":"-13.23"}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 5% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 5% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 5% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"72.5"},{"groupId":"OG001","value":"17.7"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"27.5"},{"groupId":"OG001","value":"82.3"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Kilograms [kg])","description":"Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.7","spread":"14.6"},{"groupId":"OG001","value":"2.3","spread":"9.7"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%)","description":"Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change of body weight","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.8","spread":"13.2"},{"groupId":"OG001","value":"2.3","spread":"9.1"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 10% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"61.8"},{"groupId":"OG001","value":"8.1"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"38.2"},{"groupId":"OG001","value":"91.9"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 15% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"53.4"},{"groupId":"OG001","value":"4.8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"46.6"},{"groupId":"OG001","value":"95.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)","description":"Percentage of participants who achieved \\>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 20% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"37.4"},{"groupId":"OG001","value":"3.2"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"62.6"},{"groupId":"OG001","value":"96.8"}]}]}]},{"type":"SECONDARY","title":"Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])","description":"Change from baseline in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) at week 68 is presented. CDC gender and age-specific growth charts: normal (BMI less than \\[\\<\\] 85th percentile), overweight (BMI greater than or equal to \\[\\>=\\] 85th - \\<95th percentile), obesity class I (BMI \\>=95th - \\<120% of the 95th percentile), obesity class II (BMI \\>=120% of the 95th percentile - \\<140% of the 95th percentile) and obesity class III (BMI \\>=140% of the 95th percentile). Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of BMI","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-24.9","spread":"17.0"},{"groupId":"OG001","value":"-4.5","spread":"10.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving Improvement in Weight Category (Yes/no)","description":"Percentage of participants who achieved improvement in weight category from baseline (week 0) to week 68 is presented. Improvement in weight category was defined as being in a lower weight category at week 68 compared to baseline according to CDC gender and age-specific growth charts: normal (BMI \\<85th percentile), overweight (BMI \\>=85th - \\<95th percentile), obesity class I (BMI \\>=95th - \\<120% of the 95th percentile), obesity class II (BMI \\>=120% of the 95th percentile - \\<140% of the 95th percentile) and obesity class III (BMI \\>=140% of the 95th percentile). In the reported data, 'Yes' infers the percentage of participants who have achieved improvement in weight category, whereas 'No' infers the percentage of participants who did not achieve improvement in weight category. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"71.8"},{"groupId":"OG001","value":"21.0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"28.2"},{"groupId":"OG001","value":"79.0"}]}]}]},{"type":"SECONDARY","title":"Change in BMI (Standard Deviation Score [SDS])","description":"Change in BMI SDS from baseline to week 68 is presented. The SDS scores are also called as z-scores. BMI SDS was calculated using the following formula: Z=\\[(value /M)\\^L - 1\\] / S\\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Possible values range from -3 to +3, a negative score being beneficial. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"standard deviation score","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.9"},{"groupId":"OG001","value":"-0.1","spread":"0.5"}]}]}]},{"type":"SECONDARY","title":"Change in BMI (Kilograms Per Meter Square [kg/m^2])","description":"Change in BMI (kg/m\\^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m^2","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.9","spread":"4.9"},{"groupId":"OG001","value":"0.0","spread":"3.1"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference (centimeters \\[cm\\]) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.7","spread":"12.2"},{"groupId":"OG001","value":"-0.5","spread":"6.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)","description":"Percentage of participants who achieved \\>= 5% reduction of BMI from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \\>= 5% BMI reduction, whereas 'No' infers the percentage of participants who did not achieve \\>= 5% BMI reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"75.6"},{"groupId":"OG001","value":"22.6"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"24.4"},{"groupId":"OG001","value":"77.4"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"12"},{"groupId":"OG001","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"9"},{"groupId":"OG001","value":"-1","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Change in Glycated Haemoglobin (HbA1c) (%)","description":"Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.3"},{"groupId":"OG001","value":"-0.1","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (Millimoles Per Mole [mmol/Mol])","description":"Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/mol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"3.5"},{"groupId":"OG001","value":"-1.2","spread":"2.9"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])","description":"Change in fasting plasma glucose (mmol/L) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"0.5"},{"groupId":"OG001","value":"0.0","spread":"0.5"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])","description":"Change in fasting plasma glucose (mg/dL) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"9.6"},{"groupId":"OG001","value":"0.0","spread":"8.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline","description":"Change in fasting insulin (pmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting insulin","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.64","spread":"62.9"},{"groupId":"OG001","value":"0.99","spread":"58.2"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline","description":"Change in fasting insulin (mIU/mL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting insulin","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.64","spread":"62.9"},{"groupId":"OG001","value":"0.99","spread":"58.2"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mmol/L): Ratio to Baseline","description":"Change in total cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"14.6"},{"groupId":"OG001","value":"0.98","spread":"9.4"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mg/dL): Ratio to Baseline","description":"Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"14.6"},{"groupId":"OG001","value":"0.98","spread":"9.4"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline","description":"Change in HDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), week 68:","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"17.5"},{"groupId":"OG001","value":"1.03","spread":"21.5"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline","description":"Change in HDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"57"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"17.5"},{"groupId":"OG001","value":"1.03","spread":"21.5"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline","description":"Change in LDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"20.9"},{"groupId":"OG001","value":"0.96","spread":"15.4"}]}]}]},{"type":"SECONDARY","title":"Change in LDL Cholesterol (mg/dL): Ratio to Baseline","description":"Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), week 68:","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"20.9"},{"groupId":"OG001","value":"0.96","spread":"15.4"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline","description":"Change in VLDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"46.1"},{"groupId":"OG001","value":"1.03","spread":"40.8"}]}]}]},{"type":"SECONDARY","title":"Change in VLDL Cholesterol (mg/dL): Ratio to Baseline","description":"Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"46.1"},{"groupId":"OG001","value":"1.03","spread":"40.8"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (mmol/L): Ratio to Baseline","description":"Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"45.8"},{"groupId":"OG001","value":"1.04","spread":"40.9"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (mg/dL): Ratio to Baseline","description":"Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"45.8"},{"groupId":"OG001","value":"1.04","spread":"40.9"}]}]}]},{"type":"SECONDARY","title":"Change in Alanine Aminotransferase (ALT): Ratio to Baseline","description":"Change in ALT (units per liter \\[U/L\\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.","populationDescription":"FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ALT","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.79","spread":"63.8"},{"groupId":"OG001","value":"1.00","spread":"44.3"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as greater than (\\>) 7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","populationDescription":"The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"792"},{"groupId":"OG001","value":"328"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Serious Adverse Events (SAEs)","description":"An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","populationDescription":"SAS included all randomized participants exposed to at least one dose of randomized treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"7"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from baseline to week 68 is presented. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"SAS included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute (beats/min)","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"13"},{"groupId":"OG001","value":"-1","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase: Ratio to Baseline","description":"Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"SAS included all randomized participants exposed to at least one dose of randomized treatment.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.15","spread":"17.4"},{"groupId":"OG001","value":"1.04","spread":"18.2"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase: Ratio to Baseline","description":"Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"SAS included all randomized participants exposed to at least one dose of randomized treatment.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.39","spread":"37.3"},{"groupId":"OG001","value":"1.12","spread":"37.0"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin: Ratio to Baseline","description":"Change in calcitonin (nanograms per liter \\[ng/L\\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"SAS included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcitonin","timeFrame":"Baseline (week 0), week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"55"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.14","spread":"47.0"},{"groupId":"OG001","value":"1.09","spread":"36.7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline (week 0) to week 75","description":"All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.","eventGroups":[{"id":"EG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 mg of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.","deathsNumAffected":0,"deathsNumAtRisk":133,"seriousNumAffected":15,"seriousNumAtRisk":133,"otherNumAffected":90,"otherNumAtRisk":133},{"id":"EG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.","deathsNumAffected":0,"deathsNumAtRisk":67,"seriousNumAffected":6,"seriousNumAtRisk":67,"otherNumAffected":40,"otherNumAtRisk":67}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":133},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":67}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":133},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":67}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":133},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":67}]},{"term":"COVID-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":133},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":67}]},{"term":"COVID-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":133},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":67}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 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