{"protocolSection":{"identificationModule":{"nctId":"NCT05040971","orgStudyIdInfo":{"id":"NN9536-4734"},"secondaryIdInfos":[{"id":"U1111-1253-1956","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2020-002939-29","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes","officialTitle":"Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes","acronym":"STEP 10"},"statusModule":{"statusVerifiedDate":"2026-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-09-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-01-06","type":"ACTUAL"},"completionDateStruct":{"date":"2023-07-14","type":"ACTUAL"},"studyFirstSubmitDate":"2021-09-02","studyFirstSubmitQcDate":"2021-09-02","studyFirstPostDateStruct":{"date":"2021-09-10","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-02-05","resultsFirstSubmitQcDate":"2024-08-09","resultsFirstPostDateStruct":{"date":"2024-10-28","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-01-12","lastUpdatePostDateStruct":{"date":"2026-01-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes.\n\nThis study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar.\n\nSemaglutide is compared to a \"dummy\" medicine. The \"dummy\" medicine looks like semaglutide but has no effect on the body.\n\nIn addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.\n\nParticipants will either get semaglutide or \"dummy\" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as \"dummy\" medicine.\n\nParticipants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.\n\nThe study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication.\n\nParticipants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":207,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks","interventionNames":["Drug: Semaglutide 2.4 mg"]},{"label":"Placebo (semaglutide)","type":"PLACEBO_COMPARATOR","description":"Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide 2.4 mg","description":"Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Placebo","description":"Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week","armGroupLabels":["Placebo (semaglutide)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight (Percentage [%])","description":"Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Participants With Change to Normoglycemia","description":"Number of participants in glycaemic categories, \"normoglycaemia, pre-diabetes and type 2 diabetes\" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.","timeFrame":"At week 52"}],"secondaryOutcomes":[{"measure":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline","description":"Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Total Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"},{"measure":"Change in Body Weight (Kilogram [Kg])","description":"Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to week 52"},{"measure":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"At week 52"},{"measure":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"At week 52"},{"measure":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"At week 52"},{"measure":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"At week 52"},{"measure":"Change in Pulse","description":"Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","timeFrame":"From randomisation (week 0) to end of treatment (week 52)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female aged greater than or equal to 18 years at the time of signing informed consent.\n* BMI greater than or equal to 30.0 kg/m\\^2\n* Prediabetes defined as at least one of the following:\n\n  * HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.\n  * FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.\n\nExclusion Criteria:\n\n* History of type 1 or type 2 diabetes.\n* Treatment with glucose-lowering agent(s) within 90 days before screening.\n* HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.\n* FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.\n\nA self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.\n\n* Treatment with any medication for the indication of obesity within the past 90 days before screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"LMC Clin Res Inc. Calgary","city":"Calgary","state":"Alberta","zip":"T2H 2G4","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"University of Calgary","city":"Calgary","state":"Alberta","zip":"T2T 5C7","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"C-endo Diab Endo Clin Calgery","city":"Calgary","state":"Alberta","zip":"T2V 4J2","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"Weight Wise Clinic","city":"Edmonton","state":"Alberta","zip":"T6G 2R3","country":"Canada","geoPoint":{"lat":53.55014,"lon":-113.46871}},{"facility":"Ocean West Research Clinic","city":"Surrey","state":"British Columbia","zip":"V3Z 2N6","country":"Canada","geoPoint":{"lat":49.10635,"lon":-122.82509}},{"facility":"G.A. Research Associates Ltd.","city":"Moncton","state":"New Brunswick","zip":"E1G 1A7","country":"Canada","geoPoint":{"lat":46.09454,"lon":-64.7965}},{"facility":"Nova Scotia Hlth Halifax","city":"Halifax","state":"Nova Scotia","zip":"B3H 2Y9","country":"Canada","geoPoint":{"lat":44.64269,"lon":-63.57688}},{"facility":"LMC Diabetes & Endocrinology (Barrie)","city":"Barrie","state":"Ontario","zip":"L4N 7L3","country":"Canada","geoPoint":{"lat":44.40011,"lon":-79.66634}},{"facility":"LMC ClinRsrh Inc.Brampton","city":"Brampton","state":"Ontario","zip":"L6S 0C6","country":"Canada","geoPoint":{"lat":43.68341,"lon":-79.76633}},{"facility":"LMC Clin Res Inc. Thornhill","city":"Concord","state":"Ontario","zip":"L4K 4M2","country":"Canada","geoPoint":{"lat":43.80011,"lon":-79.48291}},{"facility":"LMC Endo Ctr (Etobicoke) Ltd","city":"Etobicoke","state":"Ontario","zip":"M9R 4E1","country":"Canada","geoPoint":{"lat":43.64415,"lon":-79.56985}},{"facility":"Wharton Med Clin Trials","city":"Hamilton","state":"Ontario","zip":"L8L 5G8","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"Premier Clinical Trial Research Network (PCTRN)","city":"Hamilton","state":"Ontario","zip":"L8M 1K7","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"Milestone Research","city":"London","state":"Ontario","zip":"N5W 6A2","country":"Canada","geoPoint":{"lat":42.98339,"lon":-81.23304}},{"facility":"LMC Research Inc. Ottawa","city":"Nepean","state":"Ontario","zip":"K2J 0V2","country":"Canada","geoPoint":{"lat":45.33619,"lon":-75.7225}},{"facility":"LMC Clinical Research Inc. Oakville","city":"Oakville","state":"Ontario","zip":"L6M 1M1","country":"Canada","geoPoint":{"lat":43.45011,"lon":-79.68292}},{"facility":"Centricity Research LMC","city":"Toronto","state":"Ontario","zip":"M4G 3E8","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Toronto Sleep Institute/MedSleep","city":"Toronto","state":"Ontario","zip":"M4P 1P2","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Diabetes Heart Research Centre","city":"Toronto","state":"Ontario","zip":"M6G 1M2","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Dr Anil K Gupta Med Prof Corp","city":"Toronto","state":"Ontario","zip":"M9V 4B4","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Manna Research Mirabel","city":"Mirabel","state":"Quebec","zip":"J7J 2K8","country":"Canada","geoPoint":{"lat":45.65008,"lon":-74.08251}},{"facility":"Centre Medical Acadie","city":"Montreal","state":"Quebec","zip":"H4N 2W2","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"Clinique Medicine Urbaine du Quartier Latin, Inc.","city":"Montreal","state":"Quebec","zip":"QC H2L 4E9","country":"Canada","geoPoint":{"lat":45.50884,"lon":-73.58781}},{"facility":"LMC Clin Rsrch Inc. (Montreal)","city":"Saint-Laurent","state":"Quebec","zip":"H4T 1Z9","country":"Canada","geoPoint":{"lat":45.50008,"lon":-73.66585}},{"facility":"Centre de recherché du CHUS","city":"Sherbrooke","state":"Quebec","zip":"J1H 5N4","country":"Canada","geoPoint":{"lat":45.40008,"lon":-71.89908}},{"facility":"Ctr de Med Metab de Lanaudiere","city":"Terrebonne","state":"Quebec","zip":"J6X 4P7","country":"Canada","geoPoint":{"lat":45.70004,"lon":-73.64732}},{"facility":"CHU de Quebec-Universite Laval","city":"Québec","zip":"G1V 4G2","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Institut universitaire de cardiologie","city":"Québec","zip":"G1V 4G5","country":"Canada","geoPoint":{"lat":46.81228,"lon":-71.21454}},{"facility":"Aarhus Universitetshospital Diabetes og Hormonsygdomme","city":"Aarhus N","zip":"8200","country":"Denmark","geoPoint":{"lat":56.20367,"lon":10.17317}},{"facility":"Hvidovre Hospital Endokrinologisk forsknings afsnit 159","city":"Hvidovre","zip":"2650","country":"Denmark","geoPoint":{"lat":55.64297,"lon":12.47708}},{"facility":"Obesity Research Unit","city":"Helsinki","zip":"00014","country":"Finland","geoPoint":{"lat":60.16952,"lon":24.93545}},{"facility":"StudyCor","city":"Jyväskylä","zip":"40620","country":"Finland","geoPoint":{"lat":62.24147,"lon":25.72088}},{"facility":"Hospital Gregorio Marañón","city":"Madrid","zip":"28009","country":"Spain","geoPoint":{"lat":40.4165,"lon":-3.70256}},{"facility":"Hospital Clinico San Carlos","city":"Madrid","zip":"28040","country":"Spain","geoPoint":{"lat":40.4165,"lon":-3.70256}},{"facility":"Hospital Infanta Luisa","city":"Seville","zip":"41010","country":"Spain","geoPoint":{"lat":37.38283,"lon":-5.97317}},{"facility":"Clifton Medical Centre","city":"Rotherham","state":"South Yorkshire","zip":"S65 1DA","country":"United Kingdom","geoPoint":{"lat":53.43012,"lon":-1.35678}},{"facility":"The Health Centre","city":"Bradford on Avon","zip":"BA15 1DQ","country":"United Kingdom","geoPoint":{"lat":51.34772,"lon":-2.25065}},{"facility":"University Hospital Coventry - WISDEM Centre","city":"Coventry","zip":"CV2 2DX","country":"United Kingdom","geoPoint":{"lat":52.40656,"lon":-1.51217}},{"facility":"Claremont Medical Practice","city":"Exmouth","zip":"EX8 2JF","country":"United Kingdom","geoPoint":{"lat":50.61723,"lon":-3.40233}},{"facility":"GP Direct","city":"Harrow","zip":"HA2 0RQ","country":"United Kingdom","geoPoint":{"lat":51.57835,"lon":-0.33208}},{"facility":"Guys Hospital","city":"London","zip":"SE1 9RT","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"The Staploe Medical Centre","city":"Soham","zip":"CB7 5JD","country":"United Kingdom","geoPoint":{"lat":52.33543,"lon":0.33654}},{"facility":"MyHealth - Strensall Health Care Centre","city":"Strensall","zip":"YO32 5UA","country":"United Kingdom","geoPoint":{"lat":54.03999,"lon":-1.03512}}]},"referencesModule":{"references":[{"pmid":"39089293","type":"RESULT","citation":"McGowan BM, Bruun JM, Capehorn M, Pedersen SD, Pietilainen KH, Muniraju HAK, Quiroga M, Varbo A, Lau DCW; STEP 10 Study Group. Efficacy and safety of once-weekly semaglutide 2.4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial. Lancet Diabetes Endocrinol. 2024 Sep;12(9):631-642. doi: 10.1016/S2213-8587(24)00182-7. Epub 2024 Jul 29."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"\"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com\"","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial has a Main phase and Extension phase. Main phase: a 52-week treatment period (16 weeks of dose escalation and 36 weeks of maintenance dose). Extension phase: a 28-week off-treatment extension phase after the main phase for assessment of body weight, glycaemic and cardiovascular parameters. Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo as an adjunct to a reduced-calorie diet and increased physical activity.","recruitmentDetails":"The trial was conducted at 30 sites in 5 countries as follows: Canada (15 sites), Denmark (2 sites), Finland (2 sites), Spain (3 sites) and United Kingdom (8 sites).","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"138"},{"groupId":"FG001","numSubjects":"69"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"69"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"69"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"128"},{"groupId":"FG001","numSubjects":"64"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all the randomised participants.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"BG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"138"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"207"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53","spread":"11"},{"groupId":"BG001","value":"53","spread":"11"},{"groupId":"BG002","value":"53","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"100"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"147"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"60"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"7"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"200"}]},{"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":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"183"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"9"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Weight (Percentage [%])","description":"Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"Full analysis set (FAS) included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage (%) of body weight","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.4","spread":"7.9"},{"groupId":"OG001","value":"-2.7","spread":"4.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Week 52 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-11.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.97","ciUpperLimit":"-9.42"}]},{"type":"PRIMARY","title":"Participants With Change to Normoglycemia","description":"Number of participants in glycaemic categories, \"normoglycaemia, pre-diabetes and type 2 diabetes\" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"64"}]}],"classes":[{"categories":[{"title":"Normoglycemia","measurements":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"9"}]},{"title":"Pre-diabetes","measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"53"}]},{"title":"Type 2 diabetes","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Week 52 responses were analysed using a logistic regression model with randomised treatment as factor and baseline glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) as covariates.","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"19.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.68","ciUpperLimit":"45.21"}]},{"type":"SECONDARY","title":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.3"},{"groupId":"OG001","value":"0.1","spread":"0.2"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"0.6"},{"groupId":"OG001","value":"-0.3","spread":"0.7"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimeter (cm)","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.6","spread":"8.7"},{"groupId":"OG001","value":"-2.8","spread":"5.4"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9","spread":"13"},{"groupId":"OG001","value":"-1","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline","description":"Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.80","spread":"36.4"},{"groupId":"OG001","value":"0.96","spread":"30.6"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"16.1"},{"groupId":"OG001","value":"1.01","spread":"15.7"}]}]}]},{"type":"SECONDARY","title":"Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"12.4"},{"groupId":"OG001","value":"0.99","spread":"11.7"}]}]}]},{"type":"SECONDARY","title":"Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"26.6"},{"groupId":"OG001","value":"1.03","spread":"23.6"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.80","spread":"36.5"},{"groupId":"OG001","value":"0.96","spread":"30.7"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Kilogram [Kg])","description":"Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram (Kg)","timeFrame":"From randomisation (week 0) to week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.8","spread":"9.3"},{"groupId":"OG001","value":"-2.8","spread":"5.0"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"17"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"49"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"5"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"61"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"1"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"}]}]}]},{"type":"SECONDARY","title":"Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)","description":"Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"0"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"66"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (bpm)","timeFrame":"From randomisation (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"10"},{"groupId":"OG001","value":"0","spread":"7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From randomisation (week 0) to week 57","description":"All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.","eventGroups":[{"id":"EG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.","deathsNumAffected":2,"deathsNumAtRisk":138,"seriousNumAffected":12,"seriousNumAtRisk":138,"otherNumAffected":93,"otherNumAtRisk":138},{"id":"EG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.","deathsNumAffected":0,"deathsNumAtRisk":69,"seriousNumAffected":6,"seriousNumAtRisk":69,"otherNumAffected":30,"otherNumAtRisk":69}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Anaplastic thyroid cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Atrial flutter","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":3,"numAffected":1,"numAtRisk":69}]},{"term":"Benign prostatic hyperplasia","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Bladder neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Cataract","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Concussion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Embedded device","organSystem":"Product Issues","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Endophthalmitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Facial bones fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Invasive lobular breast carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Lumbar spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":138},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":69}]},{"term":"Mastitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":138},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":69}]},{"term":"Pancreatitis acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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