{"protocolSection":{"identificationModule":{"nctId":"NCT05144984","orgStudyIdInfo":{"id":"NN9389-4606"},"secondaryIdInfos":[{"id":"U1111-1259-2741","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2020-004863-14","type":"EUDRACT_NUMBER"},{"id":"jRCT2031210474","type":"OTHER","domain":"Japanese Registration Number"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes","officialTitle":"Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-11-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-02-13","type":"ACTUAL"},"completionDateStruct":{"date":"2023-03-23","type":"ACTUAL"},"studyFirstSubmitDate":"2021-11-22","studyFirstSubmitQcDate":"2021-11-22","studyFirstPostDateStruct":{"date":"2021-12-06","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-02-13","resultsFirstSubmitQcDate":"2026-03-21","resultsFirstPostDateStruct":{"date":"2026-04-09","type":"ACTUAL"},"dispFirstSubmitDate":"2024-02-12","dispFirstPostDateStruct":{"date":"2026-04-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-21","lastUpdatePostDateStruct":{"date":"2026-04-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.\n\nThe study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.\n\nParticipants will either get:\n\nSemaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).\n\nNNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.\n\nParticipant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.\n\nParticipant must inject the study medicines themself into the stomach, thigh, or upper arm.\n\nThe study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.\n\nWomen can only take part in the study if they are not able to become pregnant"},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":500,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"2.4 mg semaglutide + 2.4 mg NNC0480-0389","type":"EXPERIMENTAL","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.","interventionNames":["Drug: NNC0480-0389","Drug: Semaglutide"]},{"label":"Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)","type":"PLACEBO_COMPARATOR","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).","interventionNames":["Drug: Placebo (NNC080-0389)","Drug: Placebo (semaglutide)"]},{"label":"2.4 mg semaglutide + 7.2 mg NNC0480-0389","type":"EXPERIMENTAL","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide","interventionNames":["Drug: NNC0480-0389","Drug: Semaglutide"]},{"label":"2.4 mg semaglutide + 12.0 mg NNC0480-0389","type":"EXPERIMENTAL","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide","interventionNames":["Drug: NNC0480-0389","Drug: Semaglutide"]},{"label":"2.4 mg semaglutide + 21.6 mg NNC0480-0389","type":"EXPERIMENTAL","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide","interventionNames":["Drug: NNC0480-0389","Drug: Semaglutide"]},{"label":"NNC0480-0389 + placebo (semaglutide)","type":"EXPERIMENTAL","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)","interventionNames":["Drug: NNC0480-0389","Drug: Placebo (semaglutide)"]},{"label":"Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)","type":"PLACEBO_COMPARATOR","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).","interventionNames":["Drug: Placebo (NNC080-0389)","Drug: Placebo (semaglutide)"]},{"label":"Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)","type":"PLACEBO_COMPARATOR","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).","interventionNames":["Drug: Placebo (NNC080-0389)","Drug: Placebo (semaglutide)"]},{"label":"Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)","type":"PLACEBO_COMPARATOR","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).","interventionNames":["Drug: Placebo (NNC080-0389)","Drug: Placebo (semaglutide)"]},{"label":"Semaglutide 2.4 mg + placebo (NNC0480-0389)","type":"EXPERIMENTAL","description":"subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.","interventionNames":["Drug: Semaglutide","Drug: Placebo (NNC080-0389)"]}],"interventions":[{"type":"DRUG","name":"NNC0480-0389","description":"A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.","armGroupLabels":["2.4 mg semaglutide + 12.0 mg NNC0480-0389","2.4 mg semaglutide + 2.4 mg NNC0480-0389","2.4 mg semaglutide + 21.6 mg NNC0480-0389","2.4 mg semaglutide + 7.2 mg NNC0480-0389","NNC0480-0389 + placebo (semaglutide)"]},{"type":"DRUG","name":"Semaglutide","description":"A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.","armGroupLabels":["2.4 mg semaglutide + 12.0 mg NNC0480-0389","2.4 mg semaglutide + 2.4 mg NNC0480-0389","2.4 mg semaglutide + 21.6 mg NNC0480-0389","2.4 mg semaglutide + 7.2 mg NNC0480-0389","Semaglutide 2.4 mg + placebo (NNC0480-0389)"]},{"type":"DRUG","name":"Placebo (NNC080-0389)","description":"A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.","armGroupLabels":["Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)","Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)","Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)","Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)","Semaglutide 2.4 mg + placebo (NNC0480-0389)"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"A weekly dose of placebo (semaglutide). The study will last for about 41weeks.","armGroupLabels":["NNC0480-0389 + placebo (semaglutide)","Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)","Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)","Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)","Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Haemoglobin (HbA1c)","description":"Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Change From Baseline in Body Weight (Kilogram [kg])","description":"Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Percent Change From Baseline in Body Weight","description":"Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Change From Baseline in Waist Circumference","description":"Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Change From Baseline in Systolic Blood Pressure (SBP)","description":"Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in Total Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in Triglycerides - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline","description":"Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","timeFrame":"Baseline (week 0), (week 34)"},{"measure":"Number of Treatment-Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.","timeFrame":"Baseline (week 0) to (week 39)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening\n* Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose\n* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)\n* BMI greater than or equal to 25 and below 40 kg/m\\^2\n\nExclusion Criteria:\n\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pinnacle Research Group LLC","city":"Anniston","state":"Alabama","zip":"36207","country":"United States","geoPoint":{"lat":33.65983,"lon":-85.83163}},{"facility":"Synexus Clinical Research","city":"Glendale","state":"Arizona","zip":"85308","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"University of Arizona/Banner Health","city":"Phoenix","state":"Arizona","zip":"85006","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"American Clinical Trials","city":"Buena Park","state":"California","zip":"90620","country":"United States","geoPoint":{"lat":33.86751,"lon":-117.99812}},{"facility":"San Fernando Valley Hlth Inst, LLC","city":"Canoga Park","state":"California","zip":"91304","country":"United States","geoPoint":{"lat":34.20112,"lon":-118.59814}},{"facility":"Velocity Clin Res-Chula Vista","city":"Chula Vista","state":"California","zip":"91911","country":"United States","geoPoint":{"lat":32.64005,"lon":-117.0842}},{"facility":"Headlands Research California, LLC","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Valley Research","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Providence Medical Foundation","city":"Fullerton","state":"California","zip":"92835","country":"United States","geoPoint":{"lat":33.87029,"lon":-117.92534}},{"facility":"Velocity Clinical Research San Diego","city":"La Mesa","state":"California","zip":"91942","country":"United States","geoPoint":{"lat":32.76783,"lon":-117.02308}},{"facility":"First Valley Med Grp Lancaster","city":"Lancaster","state":"California","zip":"93534","country":"United States","geoPoint":{"lat":34.69804,"lon":-118.13674}},{"facility":"Torrance Clin Res Inst, Inc.","city":"Lomita","state":"California","zip":"90717","country":"United States","geoPoint":{"lat":33.79224,"lon":-118.31507}},{"facility":"Velocity Clin Res Los Angeles","city":"Los Angeles","state":"California","zip":"90017","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Valley Clinical Trials, Inc.","city":"Northridge","state":"California","zip":"91325","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"Artemis Insitute for Clin Res","city":"Riverside","state":"California","zip":"92503","country":"United States","geoPoint":{"lat":33.95335,"lon":-117.39616}},{"facility":"Artemis Institute for Clin Res","city":"San Diego","state":"California","zip":"92103","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Shahram Jacobs MD Inc.","city":"Sherman Oaks","state":"California","zip":"91403","country":"United States","geoPoint":{"lat":34.15112,"lon":-118.44925}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Northeast Research Institute","city":"Jacksonville","state":"Florida","zip":"32204","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Reyes Clinical Research, Inc","city":"Miami","state":"Florida","zip":"33175","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"South Broward Research LLC","city":"Miramar","state":"Florida","zip":"33027","country":"United States","geoPoint":{"lat":25.98731,"lon":-80.23227}},{"facility":"Clinical Trial Res Assoc,Inc","city":"Plantation","state":"Florida","zip":"33324","country":"United States","geoPoint":{"lat":26.13421,"lon":-80.23184}},{"facility":"Progressive Medical Research","city":"Port Orange","state":"Florida","zip":"32127","country":"United States","geoPoint":{"lat":29.13832,"lon":-80.99561}},{"facility":"Headlands Research - Sarasota","city":"Sarasota","state":"Florida","zip":"34243","country":"United States","geoPoint":{"lat":27.33643,"lon":-82.53065}},{"facility":"Appalachian Clinical Res LLC","city":"Adairsville","state":"Georgia","zip":"30103","country":"United States","geoPoint":{"lat":34.3687,"lon":-84.93411}},{"facility":"Solaris Clinical Research","city":"Meridian","state":"Idaho","zip":"83646","country":"United States","geoPoint":{"lat":43.61211,"lon":-116.39151}},{"facility":"Cedar-Crosse Research Center","city":"Chicago","state":"Illinois","zip":"60607","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Macoupin Research Group","city":"Gillespie","state":"Illinois","zip":"62033","country":"United States","geoPoint":{"lat":39.12977,"lon":-89.81954}},{"facility":"UnityPoint Health-Diabetes Care Center","city":"Peoria","state":"Illinois","zip":"61603","country":"United States","geoPoint":{"lat":40.69365,"lon":-89.58899}},{"facility":"Clin Invest Spec, Inc","city":"Wauconda","state":"Illinois","zip":"60084","country":"United States","geoPoint":{"lat":42.25891,"lon":-88.13925}},{"facility":"Iowa Diabetes & Endo Res Ctr","city":"West Des Moines","state":"Iowa","zip":"50265","country":"United States","geoPoint":{"lat":41.57721,"lon":-93.71133}},{"facility":"Cotton O'Neil Diab & Endo Ctr","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"The Research Group of Lexington LLC","city":"Lexington","state":"Kentucky","zip":"40503","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"L-MARC Research Center","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Centex Studies, Inc._Lake Charles","city":"Lake Charles","state":"Louisiana","zip":"70601","country":"United States","geoPoint":{"lat":30.21309,"lon":-93.2044}},{"facility":"Endo And Metab Cons","city":"Rockville","state":"Maryland","zip":"20852","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"Brigham & Women's Hospital","city":"Boston","state":"Massachusetts","zip":"02115-5804","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Arcturus HC PLC Troy Med Res","city":"Troy","state":"Michigan","zip":"48098","country":"United States","geoPoint":{"lat":42.60559,"lon":-83.14993}},{"facility":"StudyMetrix Research LLC","city":"City of Saint Peters","state":"Missouri","zip":"63303","country":"United States","geoPoint":{"lat":38.80033,"lon":-90.62651}},{"facility":"Mercury Str Med Grp, PLLC","city":"Butte","state":"Montana","zip":"59701","country":"United States","geoPoint":{"lat":46.00382,"lon":-112.53474}},{"facility":"Princeton Endo Assoc","city":"Princeton","state":"New Jersey","zip":"08540","country":"United States","geoPoint":{"lat":40.34872,"lon":-74.65905}},{"facility":"Premier Research Inc.","city":"Trenton","state":"New Jersey","zip":"08611","country":"United States","geoPoint":{"lat":40.21705,"lon":-74.74294}},{"facility":"AMC Community Endocrinology","city":"Albany","state":"New York","zip":"12203","country":"United States","geoPoint":{"lat":42.65258,"lon":-73.75623}},{"facility":"Mid Hudson Med Res-New Windsor","city":"New Windsor","state":"New York","zip":"12553","country":"United States","geoPoint":{"lat":41.47676,"lon":-74.02375}},{"facility":"University of North Carolina","city":"Chapel Hill","state":"North Carolina","zip":"27514","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"PharmQuest Life Sciences LLC","city":"Greensboro","state":"North Carolina","zip":"27408","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"Physicians East Endocrinology","city":"Greenville","state":"North Carolina","zip":"27834","country":"United States","geoPoint":{"lat":35.61266,"lon":-77.36635}},{"facility":"Piedmont Healthcare/Research","city":"Statesville","state":"North Carolina","zip":"28625","country":"United States","geoPoint":{"lat":35.78264,"lon":-80.8873}},{"facility":"Lillestol Research LLC","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Albert J Weisbrot","city":"Mason","state":"Ohio","zip":"45040-6815","country":"United States","geoPoint":{"lat":39.36006,"lon":-84.30994}},{"facility":"Advanced Med Res Maumee","city":"Maumee","state":"Ohio","zip":"43537","country":"United States","geoPoint":{"lat":41.56283,"lon":-83.65382}},{"facility":"Intend Research","city":"Norman","state":"Oklahoma","zip":"73069","country":"United States","geoPoint":{"lat":35.22257,"lon":-97.43948}},{"facility":"Essential Medical Research LLC","city":"Tulsa","state":"Oklahoma","zip":"74137","country":"United States","geoPoint":{"lat":36.15398,"lon":-95.99277}},{"facility":"CCT Research","city":"Hatboro","state":"Pennsylvania","zip":"19040","country":"United States","geoPoint":{"lat":40.17428,"lon":-75.10684}},{"facility":"Preferred Primary Care Physicians_Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","zip":"15236","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Spartanburg Medical Research","city":"Spartanburg","state":"South Carolina","zip":"29303","country":"United States","geoPoint":{"lat":34.94957,"lon":-81.93205}},{"facility":"Chattanooga Medical Research, LLC","city":"Chattanooga","state":"Tennessee","zip":"37404","country":"United States","geoPoint":{"lat":35.04563,"lon":-85.30968}},{"facility":"Clinical Neuroscience Solutions","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Velocity Clinical Res-Dallas","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"UT Southwestern Med Cntr","city":"Dallas","state":"Texas","zip":"75390-9302","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Centex Studies, Inc.","city":"Houston","state":"Texas","zip":"77058","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Juno Research, LLC","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Southwest Clinical Trials","city":"Houston","state":"Texas","zip":"77074","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Centex Studies","city":"Houston","state":"Texas","zip":"77090","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Quality Research Inc","city":"San Antonio","state":"Texas","zip":"78209","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"VIP Trials_San Antonio","city":"San Antonio","state":"Texas","zip":"78230","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Consano Clinical Research, LLC","city":"Shavano Park","state":"Texas","zip":"78231","country":"United States","geoPoint":{"lat":29.58495,"lon":-98.55252}},{"facility":"Simcare Medical Research, LLC","city":"Sugar Land","state":"Texas","zip":"77478","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"Advanced Research Institute","city":"Ogden","state":"Utah","zip":"84405","country":"United States","geoPoint":{"lat":41.223,"lon":-111.97383}},{"facility":"York Clinical Research LLC","city":"Norfolk","state":"Virginia","zip":"23504","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"facility":"Capital Clin Res Ctr,LLC","city":"Olympia","state":"Washington","zip":"98502","country":"United States","geoPoint":{"lat":47.04491,"lon":-122.90169}},{"facility":"Medical centre Zdrave 1 OOD","city":"Kozloduy","zip":"3320","country":"Bulgaria","geoPoint":{"lat":43.77691,"lon":23.73001}},{"facility":"IPMC - Dr. Elizabeta Dimitrova","city":"Petrich","zip":"2850","country":"Bulgaria","geoPoint":{"lat":41.39365,"lon":23.20012}},{"facility":"UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases","city":"Sofia","zip":"1431","country":"Bulgaria","geoPoint":{"lat":42.69751,"lon":23.32415}},{"facility":"Medical centre - Doverie AD","city":"Sofia","zip":"1632","country":"Bulgaria","geoPoint":{"lat":42.69751,"lon":23.32415}},{"facility":"UMHAT Sofiamed EAD","city":"Sofia","zip":"1797","country":"Bulgaria","geoPoint":{"lat":42.69751,"lon":23.32415}},{"facility":"Prevencia - 2000 - MCOC OOD","city":"Stara Zagora","zip":"6000","country":"Bulgaria","geoPoint":{"lat":42.43205,"lon":25.64262}},{"facility":"MC Berbatov EOOD, Cherni Drin","city":"Yambol","zip":"8600","country":"Bulgaria","geoPoint":{"lat":42.48243,"lon":26.50006}},{"facility":"Aarhus Universitetshospital Diabetes og Hormonsygdomme","city":"Aarhus N","zip":"8200","country":"Denmark","geoPoint":{"lat":56.20367,"lon":10.17317}},{"facility":"Gentofte Hospital - Center for Klinisk Metabolisk Forskning","city":"Hellerup","zip":"2900","country":"Denmark","geoPoint":{"lat":55.73204,"lon":12.57093}},{"facility":"Hvidovre Hospital Endokrinologisk forsknings afsnit 159","city":"Hvidovre","zip":"2650","country":"Denmark","geoPoint":{"lat":55.64297,"lon":12.47708}},{"facility":"University Hospital of Athens ATTIKON","city":"Athens","state":"Attica","zip":"12462","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"facility":"Iatriko Psychicou Private Clinic","city":"Athens","zip":"115 25","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"facility":"\"Laiko\" General Hospital of Athens","city":"Athens","zip":"11527","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"facility":"Alexandra General Hospital, Therapeutic Clinic","city":"Athens","zip":"11528","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"facility":"Iatriko Athinon (Athens Medical Canter)","city":"Athens","zip":"15125","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"facility":"Iatriko Athinon 'Palaiou Falirou'","city":"Athens","zip":"17562","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"facility":"EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes","city":"Thessaloniki","zip":"54645","country":"Greece","geoPoint":{"lat":40.64072,"lon":22.93493}},{"facility":"\"Thermi\" Private Hosital","city":"Thessaloniki","zip":"57001","country":"Greece","geoPoint":{"lat":40.64072,"lon":22.93493}},{"facility":"PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum","city":"Pécs","state":"Baranya Vármegye","zip":"7623","country":"Hungary","geoPoint":{"lat":46.07617,"lon":18.22814}},{"facility":"Debreceni Egyetem Belgyógyászati Klinika","city":"Debrecen","state":"Hajdú-Bihar","zip":"4032","country":"Hungary","geoPoint":{"lat":47.53167,"lon":21.62444}},{"facility":"Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház","city":"Békéscsaba","zip":"5600","country":"Hungary","geoPoint":{"lat":46.68333,"lon":21.1}},{"facility":"Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.","city":"Budapest","zip":"1036","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"SOTE ÁOK I. sz. Belgyógyászati és Onkológiai Klinika","city":"Budapest","zip":"1083","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Bajcsy-Zsilinszky Kórház","city":"Budapest","zip":"1106","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"MED-TIMA Kft.","city":"Budapest","zip":"1132","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"MH Egészségügyi Központ","city":"Budapest","zip":"1134","country":"Hungary","geoPoint":{"lat":47.49835,"lon":19.04045}},{"facility":"Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület","city":"Debrecen","zip":"4043","country":"Hungary","geoPoint":{"lat":47.53167,"lon":21.62444}},{"facility":"Békés Megyei Központi Kórház","city":"Gyula","zip":"5700","country":"Hungary","geoPoint":{"lat":46.65,"lon":21.28333}},{"facility":"Kaposi Mór Oktató Kórház","city":"Kaposvár","zip":"7400","country":"Hungary","geoPoint":{"lat":46.36667,"lon":17.8}},{"facility":"Vas Vármegyei Markusovszky Egyetemi Oktatókórház","city":"Szombathely","zip":"9700","country":"Hungary","geoPoint":{"lat":47.23088,"lon":16.62155}},{"facility":"Szent Borbála Kórház","city":"Tatabánya","zip":"2800","country":"Hungary","geoPoint":{"lat":47.59247,"lon":18.38099}},{"facility":"Naka Kinen Clinic_Internal medicine","city":"Ibaraki","zip":"311-0113","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"Yoshimura clinic","city":"Kumamoto","zip":"861-8039","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Kansai Electric Power Hospital_Center for Diabetes","city":"Osaka","zip":"553-0003","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Tokyo Center Clinic","city":"Tokyo","zip":"103-0028","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"ToCROM Clinic_Internal Medicine","city":"Tokyo","zip":"160-0008","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Higashi-shinjuku clinic","city":"Tokyo","zip":"169-0072","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"NZOZ Vita-Diabetica Malgorzata Buraczyk","city":"Bialystok","state":"Podlaskie Voivodeship","zip":"15-879","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Krakowskie Centrum Medyczne Sp. z o.o.","city":"Krakow","zip":"31-501","country":"Poland","geoPoint":{"lat":50.06143,"lon":19.93658}},{"facility":"Globe Badania Kliniczne Sp. z o.o.","city":"Kłodzko","zip":"57-300","country":"Poland","geoPoint":{"lat":50.43488,"lon":16.66145}},{"facility":"Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.","city":"Lodz","zip":"90-338","country":"Poland","geoPoint":{"lat":51.77058,"lon":19.47395}},{"facility":"FutureMeds Sp. z o.o. Lodz","city":"Lodz","zip":"91-363","country":"Poland","geoPoint":{"lat":51.77058,"lon":19.47395}},{"facility":"Diabetica Sp. z o.o.","city":"Nysa","zip":"48-300","country":"Poland","geoPoint":{"lat":50.47379,"lon":17.33437}},{"facility":"Centrum Medyczne dr Sudnik","city":"Sokółka","zip":"16-100","country":"Poland","geoPoint":{"lat":53.40715,"lon":23.50228}},{"facility":"Osrodek Badan Klinicznych Clinsante","city":"Torun","zip":"87-100","country":"Poland","geoPoint":{"lat":53.01375,"lon":18.59814}},{"facility":"Centrum Medyczne AMED Warszawa","city":"Warsaw","zip":"00-215","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji","city":"Warsaw","zip":"02-507","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"FutureMeds Sp. z o.o.","city":"Wroclaw","zip":"50-088","country":"Poland","geoPoint":{"lat":51.10286,"lon":17.03006}},{"facility":"SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze","city":"Zabrze","zip":"41-800","country":"Poland","geoPoint":{"lat":50.32492,"lon":18.78576}},{"facility":"Velocity Nova Sp. z o.o.","city":"Staszów","state":"Świętokrzyskie Voivodeship","zip":"28-200","country":"Poland","geoPoint":{"lat":50.56307,"lon":21.16593}},{"facility":"Tumen State Medical University","city":"Tyumen","state":"Russia","zip":"625023","country":"Russia","geoPoint":{"lat":57.15222,"lon":65.52722}},{"facility":"LLC RC Medical","city":"Novosibirsk","zip":"630005","country":"Russia","geoPoint":{"lat":55.02259,"lon":82.93175}},{"facility":"Penza Regional Clinical Hospital named after N.N. Burdenko","city":"Penza","zip":"440026","country":"Russia","geoPoint":{"lat":53.19568,"lon":45.01075}},{"facility":"Medinet LLC","city":"Saint Petersburg","zip":"194356","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"facility":"CHC Zvezdara, Clinical department for endocrinology","city":"Belgrade","zip":"11000","country":"Serbia","geoPoint":{"lat":44.80401,"lon":20.46513}},{"facility":"Endocrinology, Diabetes and Metabolism Diseases Clinic","city":"Belgrade","zip":"11000","country":"Serbia","geoPoint":{"lat":44.80401,"lon":20.46513}},{"facility":"Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department","city":"Kragujevac","zip":"34000","country":"Serbia","geoPoint":{"lat":44.01667,"lon":20.91667}},{"facility":"Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr","city":"Kragujevac","zip":"34000","country":"Serbia","geoPoint":{"lat":44.01667,"lon":20.91667}}]},"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 had a 34-week intervention period (10 weeks of dose escalation period and followed by two 12 -week maintenance period), followed by a 5-week follow-up period.","recruitmentDetails":"The trial was conducted in 9 countries (86 sites screened/83 randomised participants) as follows: Bulgaria: 6/6; Denmark: 3/3; Greece: 7/7; Hungary: 9/9; Japan: 6/6; Poland: 10/10; Russia: 4/4; Serbia: 3/3; United States of America (USA): 38/35. In addition, Hungary (1 site), Poland (1 site), Serbia (1 site) and USA (5 site) were approved by the institutional review board, but did not screen any participants.","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"FG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"FG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"FG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"FG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"FG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"FG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"77"},{"groupId":"FG003","numSubjects":"77"},{"groupId":"FG004","numSubjects":"75"},{"groupId":"FG005","numSubjects":"59"},{"groupId":"FG006","numSubjects":"61"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"77"},{"groupId":"FG003","numSubjects":"77"},{"groupId":"FG004","numSubjects":"75"},{"groupId":"FG005","numSubjects":"59"},{"groupId":"FG006","numSubjects":"61"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"77"},{"groupId":"FG003","numSubjects":"77"},{"groupId":"FG004","numSubjects":"75"},{"groupId":"FG005","numSubjects":"59"},{"groupId":"FG006","numSubjects":"61"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"77"},{"groupId":"FG003","numSubjects":"77"},{"groupId":"FG004","numSubjects":"75"},{"groupId":"FG005","numSubjects":"59"},{"groupId":"FG006","numSubjects":"61"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"72"},{"groupId":"FG002","numSubjects":"74"},{"groupId":"FG003","numSubjects":"74"},{"groupId":"FG004","numSubjects":"72"},{"groupId":"FG005","numSubjects":"57"},{"groupId":"FG006","numSubjects":"59"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Investigator decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"BG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"BG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"BG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"BG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"BG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"BG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."},{"id":"BG007","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"77"},{"groupId":"BG003","value":"77"},{"groupId":"BG004","value":"75"},{"groupId":"BG005","value":"59"},{"groupId":"BG006","value":"61"},{"groupId":"BG007","value":"500"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59","spread":"11"},{"groupId":"BG001","value":"57","spread":"10"},{"groupId":"BG002","value":"58","spread":"10"},{"groupId":"BG003","value":"59","spread":"9"},{"groupId":"BG004","value":"58","spread":"9"},{"groupId":"BG005","value":"57","spread":"10"},{"groupId":"BG006","value":"58","spread":"9"},{"groupId":"BG007","value":"58","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"38"},{"groupId":"BG004","value":"27"},{"groupId":"BG005","value":"22"},{"groupId":"BG006","value":"27"},{"groupId":"BG007","value":"198"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"39"},{"groupId":"BG004","value":"48"},{"groupId":"BG005","value":"37"},{"groupId":"BG006","value":"34"},{"groupId":"BG007","value":"302"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"8"},{"groupId":"BG007","value":"54"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"72"},{"groupId":"BG003","value":"70"},{"groupId":"BG004","value":"65"},{"groupId":"BG005","value":"54"},{"groupId":"BG006","value":"53"},{"groupId":"BG007","value":"446"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"7"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"60"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"17"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"66"},{"groupId":"BG003","value":"63"},{"groupId":"BG004","value":"64"},{"groupId":"BG005","value":"49"},{"groupId":"BG006","value":"53"},{"groupId":"BG007","value":"420"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per litre (mmol/L)","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"2.6"},{"groupId":"OG001","value":"-3.4","spread":"2.1"},{"groupId":"OG002","value":"-3.8","spread":"2.4"},{"groupId":"OG003","value":"-3.8","spread":"2.9"},{"groupId":"OG004","value":"-3.6","spread":"1.8"},{"groupId":"OG005","value":"-1.4","spread":"2.8"},{"groupId":"OG006","value":"-0.1","spread":"3.2"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (Kilogram [kg])","description":"Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.9","spread":"5.8"},{"groupId":"OG001","value":"-12","spread":"7.7"},{"groupId":"OG002","value":"-10","spread":"5.9"},{"groupId":"OG003","value":"-12","spread":"5.4"},{"groupId":"OG004","value":"-9.8","spread":"5.8"},{"groupId":"OG005","value":"-4.7","spread":"5.1"},{"groupId":"OG006","value":"-2.6","spread":"3.9"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight","description":"Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percent Change of body weight","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.3","spread":"5.8"},{"groupId":"OG001","value":"-13","spread":"7.3"},{"groupId":"OG002","value":"-11","spread":"5.8"},{"groupId":"OG003","value":"-13","spread":"5.4"},{"groupId":"OG004","value":"-10","spread":"6.3"},{"groupId":"OG005","value":"-4.3","spread":"4.5"},{"groupId":"OG006","value":"-2.7","spread":"4.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference","description":"Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8","spread":"5"},{"groupId":"OG001","value":"-11","spread":"7"},{"groupId":"OG002","value":"-9","spread":"7"},{"groupId":"OG003","value":"-10","spread":"7"},{"groupId":"OG004","value":"-8","spread":"6"},{"groupId":"OG005","value":"-5","spread":"5"},{"groupId":"OG006","value":"-3","spread":"5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Systolic Blood Pressure (SBP)","description":"Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6","spread":"12"},{"groupId":"OG001","value":"-10","spread":"14"},{"groupId":"OG002","value":"-9","spread":"13"},{"groupId":"OG003","value":"-13","spread":"12"},{"groupId":"OG004","value":"-5","spread":"16"},{"groupId":"OG005","value":"-3","spread":"12"},{"groupId":"OG006","value":"0","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in Total Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"42"},{"groupId":"OG006","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"19.7"},{"groupId":"OG001","value":"0.89","spread":"22.7"},{"groupId":"OG002","value":"0.90","spread":"21.7"},{"groupId":"OG003","value":"0.90","spread":"17.3"},{"groupId":"OG004","value":"0.93","spread":"18.2"},{"groupId":"OG005","value":"1.00","spread":"22.9"},{"groupId":"OG006","value":"0.96","spread":"16.2"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"42"},{"groupId":"OG006","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"17.6"},{"groupId":"OG001","value":"1.06","spread":"19.8"},{"groupId":"OG002","value":"1.07","spread":"16.7"},{"groupId":"OG003","value":"1.00","spread":"16.0"},{"groupId":"OG004","value":"1.04","spread":"15.6"},{"groupId":"OG005","value":"1.04","spread":"16.2"},{"groupId":"OG006","value":"1.04","spread":"17.0"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"61"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"58"},{"groupId":"OG005","value":"41"},{"groupId":"OG006","value":"34"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"28.4"},{"groupId":"OG001","value":"0.85","spread":"46.5"},{"groupId":"OG002","value":"0.91","spread":"37.5"},{"groupId":"OG003","value":"0.88","spread":"36.0"},{"groupId":"OG004","value":"0.95","spread":"32.2"},{"groupId":"OG005","value":"0.96","spread":"53.5"},{"groupId":"OG006","value":"0.96","spread":"29.8"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"42"},{"groupId":"OG006","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.75","spread":"54.0"},{"groupId":"OG001","value":"0.76","spread":"46.4"},{"groupId":"OG002","value":"0.72","spread":"48.9"},{"groupId":"OG003","value":"0.78","spread":"48.2"},{"groupId":"OG004","value":"0.72","spread":"39.9"},{"groupId":"OG005","value":"0.95","spread":"47.9"},{"groupId":"OG006","value":"0.86","spread":"44.5"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in Triglycerides - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"42"},{"groupId":"OG006","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.75","spread":"53.9"},{"groupId":"OG001","value":"0.76","spread":"46.1"},{"groupId":"OG002","value":"0.72","spread":"49.1"},{"groupId":"OG003","value":"0.78","spread":"47.8"},{"groupId":"OG004","value":"0.72","spread":"40.0"},{"groupId":"OG005","value":"0.96","spread":"47.8"},{"groupId":"OG006","value":"0.86","spread":"44.7"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline","description":"Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"58"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.85","spread":"76.1"},{"groupId":"OG001","value":"0.74","spread":"66.0"},{"groupId":"OG002","value":"0.77","spread":"43.5"},{"groupId":"OG003","value":"0.75","spread":"64.9"},{"groupId":"OG004","value":"0.88","spread":"42.3"},{"groupId":"OG005","value":"0.96","spread":"51.1"},{"groupId":"OG006","value":"0.91","spread":"47.3"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ApoB","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"22.8"},{"groupId":"OG001","value":"0.84","spread":"25.7"},{"groupId":"OG002","value":"0.85","spread":"23.5"},{"groupId":"OG003","value":"0.85","spread":"22.1"},{"groupId":"OG004","value":"0.91","spread":"18.4"},{"groupId":"OG005","value":"1.00","spread":"28.2"},{"groupId":"OG006","value":"0.94","spread":"14.7"}]}]}]},{"type":"SECONDARY","title":"Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline","description":"Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of hsCRP","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"59"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.56","spread":"107.0"},{"groupId":"OG001","value":"0.54","spread":"136.9"},{"groupId":"OG002","value":"0.64","spread":"147.9"},{"groupId":"OG003","value":"0.66","spread":"135.5"},{"groupId":"OG004","value":"0.61","spread":"141.5"},{"groupId":"OG005","value":"0.82","spread":"89.7"},{"groupId":"OG006","value":"0.93","spread":"201.6"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.","populationDescription":"Safety Analysis Set (SAS) included all participants exposed to randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Baseline (week 0) to (week 39)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"77"},{"groupId":"OG004","value":"75"},{"groupId":"OG005","value":"59"},{"groupId":"OG006","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"304"},{"groupId":"OG002","value":"206"},{"groupId":"OG003","value":"308"},{"groupId":"OG004","value":"271"},{"groupId":"OG005","value":"240"},{"groupId":"OG006","value":"95"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Glycosylated Haemoglobin (HbA1c)","description":"Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.","populationDescription":"Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Baseline (week 0), (week 34)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34)."},{"id":"OG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34)."},{"id":"OG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34)."},{"id":"OG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34)."},{"id":"OG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"OG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"OG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"77"},{"groupId":"OG004","value":"75"},{"groupId":"OG005","value":"59"},{"groupId":"OG006","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.3","spread":"0.9"},{"groupId":"OG001","value":"-2.2","spread":"0.8"},{"groupId":"OG002","value":"-2.2","spread":"1.1"},{"groupId":"OG003","value":"-2.3","spread":"1.0"},{"groupId":"OG004","value":"-2.3","spread":"0.9"},{"groupId":"OG005","value":"-1.1","spread":"1.1"},{"groupId":"OG006","value":"-0.4","spread":"1.2"}]}]}],"analyses":[{"groupIds":["OG000","OG006"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference","paramValue":"-1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.3","ciUpperLimit":"-1.4"},{"groupIds":["OG001","OG006"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference","paramValue":"-2.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.5","ciUpperLimit":"-1.5"},{"groupIds":["OG002","OG006"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference","paramValue":"-1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.4","ciUpperLimit":"-1.5"},{"groupIds":["OG003","OG006"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline HbA1c as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated treatment difference","paramValue":"-1.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.4","ciUpperLimit":"-1.5"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline (week 0) to week 39","description":"All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.","eventGroups":[{"id":"EG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).","deathsNumAffected":0,"deathsNumAtRisk":77,"seriousNumAffected":6,"seriousNumAtRisk":77,"otherNumAffected":40,"otherNumAtRisk":77},{"id":"EG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).","deathsNumAffected":0,"deathsNumAtRisk":74,"seriousNumAffected":3,"seriousNumAtRisk":74,"otherNumAffected":44,"otherNumAtRisk":74},{"id":"EG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).","deathsNumAffected":0,"deathsNumAtRisk":77,"seriousNumAffected":2,"seriousNumAtRisk":77,"otherNumAffected":36,"otherNumAtRisk":77},{"id":"EG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).","deathsNumAffected":0,"deathsNumAtRisk":77,"seriousNumAffected":5,"seriousNumAtRisk":77,"otherNumAffected":37,"otherNumAtRisk":77},{"id":"EG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.","deathsNumAffected":0,"deathsNumAtRisk":75,"seriousNumAffected":3,"seriousNumAtRisk":75,"otherNumAffected":34,"otherNumAtRisk":75},{"id":"EG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.","deathsNumAffected":0,"deathsNumAtRisk":59,"seriousNumAffected":2,"seriousNumAtRisk":59,"otherNumAffected":25,"otherNumAtRisk":59},{"id":"EG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.","deathsNumAffected":0,"deathsNumAtRisk":61,"seriousNumAffected":2,"seriousNumAtRisk":61,"otherNumAffected":23,"otherNumAtRisk":61}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Acute hepatic failure","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Ascites","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Atrioventricular block complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Atrioventricular block second degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Congestive cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Coronary artery occlusion","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Coronary artery stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Duodenitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Gastric haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Giant cell arteritis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Hepatic cirrhosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Humerus fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Pancreatic disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Parathyroid cyst","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Portal hypertension","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Prostate cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Pulmonary fibrosis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Supraventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"VIth nerve paralysis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Varices oesophageal","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Vascular device infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]}],"otherEvents":[{"term":"Amylase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":77},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":7,"numAffected":4,"numAtRisk":77},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":75},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":74},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":3,"numAffected":2,"numAtRisk":61}]},{"term":"COVID-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":77},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":74},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":77},{"groupId":"EG003","numEvents":9,"numAffected":9,"numAtRisk":77},{"groupId":"EG004","numEvents":7,"numAffected":7,"numAtRisk":75},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":59},{"groupId":"EG006","numEvents":8,"numAffected":8,"numAtRisk":61}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG001","numEvents":7,"numAffected":6,"numAtRisk":74},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":77},{"groupId":"EG003","numEvents":6,"numAffected":6,"numAtRisk":77},{"groupId":"EG004","numEvents":6,"numAffected":4,"numAtRisk":75},{"groupId":"EG005","numEvents":3,"numAffected":3,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":74},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":77},{"groupId":"EG003","numEvents":7,"numAffected":7,"numAtRisk":77},{"groupId":"EG004","numEvents":8,"numAffected":8,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":25,"numAffected":11,"numAtRisk":77},{"groupId":"EG001","numEvents":30,"numAffected":16,"numAtRisk":74},{"groupId":"EG002","numEvents":22,"numAffected":11,"numAtRisk":77},{"groupId":"EG003","numEvents":18,"numAffected":10,"numAtRisk":77},{"groupId":"EG004","numEvents":21,"numAffected":14,"numAtRisk":75},{"groupId":"EG005","numEvents":12,"numAffected":5,"numAtRisk":59},{"groupId":"EG006","numEvents":9,"numAffected":7,"numAtRisk":61}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":74},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":77},{"groupId":"EG004","numEvents":6,"numAffected":5,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":74},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":6,"numAffected":4,"numAtRisk":75},{"groupId":"EG005","numEvents":2,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":5,"numAffected":2,"numAtRisk":74},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":77},{"groupId":"EG003","numEvents":4,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":6,"numAffected":5,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":9,"numAffected":4,"numAtRisk":75},{"groupId":"EG005","numEvents":3,"numAffected":2,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":74},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":6,"numAffected":5,"numAtRisk":75},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":6,"numAtRisk":77},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":74},{"groupId":"EG002","numEvents":7,"numAffected":5,"numAtRisk":77},{"groupId":"EG003","numEvents":6,"numAffected":3,"numAtRisk":77},{"groupId":"EG004","numEvents":16,"numAffected":7,"numAtRisk":75},{"groupId":"EG005","numEvents":12,"numAffected":5,"numAtRisk":59},{"groupId":"EG006","numEvents":2,"numAffected":2,"numAtRisk":61}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":74},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":59},{"groupId":"EG006","numEvents":6,"numAffected":6,"numAtRisk":61}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG001","numEvents":5,"numAffected":4,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Injection site erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":10,"numAffected":4,"numAtRisk":77},{"groupId":"EG003","numEvents":25,"numAffected":6,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":23,"numAffected":6,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Injection site pruritus","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":74},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG003","numEvents":38,"numAffected":5,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":61,"numAffected":5,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Injection site reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":77},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":74},{"groupId":"EG002","numEvents":4,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":3,"numAffected":1,"numAtRisk":77},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":75},{"groupId":"EG005","numEvents":13,"numAffected":6,"numAtRisk":59},{"groupId":"EG006","numEvents":0,"numAffected":0,"numAtRisk":61}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG001","numEvents":10,"numAffected":9,"numAtRisk":74},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":8,"numAffected":7,"numAtRisk":77},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":75},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":59},{"groupId":"EG006","numEvents":2,"numAffected":2,"numAtRisk":61}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":77},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":74},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":75},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":59},{"groupId":"EG006","numEvents":2,"numAffected":2,"numAtRisk":61}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":21,"numAffected":15,"numAtRisk":77},{"groupId":"EG001","numEvents":25,"numAffected":9,"numAtRisk":74},{"groupId":"EG002","numEvents":8,"numAffected":5,"numAtRisk":77},{"groupId":"EG003","numEvents":13,"numAffected":10,"numAtRisk":77},{"groupId":"EG004","numEvents":29,"numAffected":17,"numAtRisk":75},{"groupId":"EG005","numEvents":8,"numAffected":4,"numAtRisk":59},{"groupId":"EG006","numEvents":2,"numAffected":1,"numAtRisk":61}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":77},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":74},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":77},{"groupId":"EG004","numEvents":2,"numAffected":2,"numAtRisk":75},{"groupId":"EG005","numEvents":4,"numAffected":4,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG001","numEvents":9,"numAffected":7,"numAtRisk":74},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":77},{"groupId":"EG003","numEvents":7,"numAffected":5,"numAtRisk":77},{"groupId":"EG004","numEvents":12,"numAffected":10,"numAtRisk":75},{"groupId":"EG005","numEvents":2,"numAffected":2,"numAtRisk":59},{"groupId":"EG006","numEvents":1,"numAffected":1,"numAtRisk":61}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property."},"pointOfContact":{"title":"Clinical Reporting Office (2834)","organization":"Novo Nordisk A/S","email":"clinicaltrials@novonordisk.com","phone":"(+1) 866-867-7178"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-09-03","uploadDate":"2026-02-13T03:37","filename":"Prot_000.pdf","size":1497496},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2022-11-08","uploadDate":"2026-02-13T03:37","filename":"SAP_001.pdf","size":914177}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2026-03-06","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C000591245","term":"semaglutide"}]}},"hasResults":true}