{"protocolSection":{"identificationModule":{"nctId":"NCT05478252","orgStudyIdInfo":{"id":"NN9535-4820"},"secondaryIdInfos":[{"id":"U1111-1266-2391","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2021-001501-69","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes","officialTitle":"Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-08-03","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-08-09","type":"ACTUAL"},"completionDateStruct":{"date":"2023-09-18","type":"ACTUAL"},"studyFirstSubmitDate":"2022-07-26","studyFirstSubmitQcDate":"2022-07-26","studyFirstPostDateStruct":{"date":"2022-07-28","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-08-07","resultsFirstSubmitQcDate":"2024-09-16","resultsFirstPostDateStruct":{"date":"2024-10-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-24","lastUpdatePostDateStruct":{"date":"2025-12-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months)."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":388,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide J","type":"EXPERIMENTAL","description":"Participants will initially receive 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly (OW) and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.","interventionNames":["Drug: Semaglutide J"]},{"label":"Semaglutide B","type":"ACTIVE_COMPARATOR","description":"Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.","interventionNames":["Drug: Semaglutide B"]}],"interventions":[{"type":"DRUG","name":"Semaglutide J","description":"Participants will initially receive 0.25 mg subcutaneous injections of semaglutide J OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).","armGroupLabels":["Semaglutide J"]},{"type":"DRUG","name":"Semaglutide B","description":"Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).","armGroupLabels":["Semaglutide B"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.","timeFrame":"From baseline (week 0) to end of treatment (week 28)"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.","timeFrame":"From baseline (week 0) to end of treatment (week 28)"},{"measure":"Number of Treatment-Emergent Adverse Events (TEAEs)","description":"An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP. All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.","timeFrame":"From the time of first dosing (week 0) to end of study (week 33)"},{"measure":"Occurrence of Anti-semaglutide Antibodies (Yes/no)","description":"Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies, whereas 'No' infers who tested negative for anti semaglutide antibodies.","timeFrame":"From baseline (week 0) to end of study (week 33)"},{"measure":"Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)","description":"Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies.","timeFrame":"From baseline (week 0) to end of study (week 33)"},{"measure":"Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)","description":"Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1).","timeFrame":"From baseline (week 0) to end of study (week 33)"},{"measure":"Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)","description":"Occurrence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 at week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1.","timeFrame":"At week 33"},{"measure":"Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total","description":"Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.","timeFrame":"At week 33"},{"measure":"Anti-semaglutide Antibodies Level (Measured as Titre)","description":"Anti-semaglutide antibodies level measured as titre at week 33 is presented.","timeFrame":"At week 33"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening.\n* Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose.\n* HbA1c of 7.0-10.5 percentage (%) \\[53-91.3 millimoles per mole (mmol/mol)\\] (both inclusive).\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\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 nondilated examination.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"64 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 2834)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Prime Medical Group, LLC","city":"Gilbert","state":"Arizona","zip":"85296","country":"United States","geoPoint":{"lat":33.35283,"lon":-111.78903}},{"facility":"FDRC","city":"Costa Mesa","state":"California","zip":"92627","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"Velocity Clinical Research San Diego","city":"La Mesa","state":"California","zip":"91942","country":"United States","geoPoint":{"lat":32.76783,"lon":-117.02308}},{"facility":"Velocity Clin Res Los Angeles","city":"Los Angeles","state":"California","zip":"90017","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"LCGK Research","city":"San Carlos","state":"California","zip":"94070","country":"United States","geoPoint":{"lat":37.50716,"lon":-122.26052}},{"facility":"San Diego Family Care_San Diego","city":"San Diego","state":"California","zip":"92111","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Encompass Clinical Research_Spring Valley","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"Med Partners, Inc.","city":"Toluca Lake","state":"California","zip":"91602","country":"United States","geoPoint":{"lat":34.15206,"lon":-118.35719}},{"facility":"University Clin Investigators","city":"Tustin","state":"California","zip":"92780","country":"United States","geoPoint":{"lat":33.74585,"lon":-117.82617}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Innovative Research of W Florida Inc.","city":"Clearwater","state":"Florida","zip":"33756","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Innovative Research of W FL","city":"Clearwater","state":"Florida","zip":"33756","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Alliance for Multispec Res","city":"Coral Gables","state":"Florida","zip":"33134","country":"United States","geoPoint":{"lat":25.72149,"lon":-80.26838}},{"facility":"Encore Medical Research LLC","city":"Hollywood","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"New Horizon Research Center","city":"Miami","state":"Florida","zip":"33165","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Reyes Clinical Research, Inc","city":"Miami","state":"Florida","zip":"33175","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"International Research Associates, LLC_Miami","city":"Miami","state":"Florida","zip":"33183","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":"Adult Medicine of Lake County, Inc.","city":"Mt. 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Total treatment period was 28 weeks."},{"id":"FG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"291"},{"groupId":"FG001","numSubjects":"97"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"291"},{"groupId":"FG001","numSubjects":"97"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"291"},{"groupId":"FG001","numSubjects":"97"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"283"},{"groupId":"FG001","numSubjects":"91"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomized participants","groups":[{"id":"BG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"BG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"291"},{"groupId":"BG001","value":"97"},{"groupId":"BG002","value":"388"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.7","spread":"7.7"},{"groupId":"BG001","value":"54.8","spread":"7.1"},{"groupId":"BG002","value":"54.0","spread":"7.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"128"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"175"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"213"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"81"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"235"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"307"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"39"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"60"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"214"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"286"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycosylated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.","populationDescription":"Full analysis set included all randomised participants. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of glycosylated haemoglobin","timeFrame":"From baseline (week 0) to end of treatment (week 28)","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"91"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"1.0"},{"groupId":"OG001","value":"-1.6","spread":"1.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS.","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.30","ciUpperLimit":"0.08"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.","populationDescription":"Full analysis set included all randomised participants. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"From baseline (week 0) to end of treatment (week 28)","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"91"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.0","spread":"5.0"},{"groupId":"OG001","value":"-4.6","spread":"4.4"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-Emergent Adverse Events (TEAEs)","description":"An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP. All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.","populationDescription":"Safety analysis set included all participants who are exposed to study intervention.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From the time of first dosing (week 0) to end of study (week 33)","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"291"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"52"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Antibodies (Yes/no)","description":"Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies, whereas 'No' infers who tested negative for anti semaglutide antibodies.","populationDescription":"Safety analysis set included all participants who are exposed to study intervention. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From baseline (week 0) to end of study (week 33)","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"90"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"90"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)","description":"Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies.","populationDescription":"Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point.","reportingStatus":"POSTED","timeFrame":"From baseline (week 0) to end of study (week 33)","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)","description":"Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1).","populationDescription":"Safety analysis set included all participants who are exposed to study intervention. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From baseline (week 0) to end of study (week 33)","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)","description":"Occurrence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 at week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1.","populationDescription":"Safety analysis set included all participants who are exposed to study intervention. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 33","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total","description":"Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.","populationDescription":"Safety analysis set included all participants who are exposed to study intervention. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of Antisemaglutide Antibodies","timeFrame":"At week 33","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.47","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Anti-semaglutide Antibodies Level (Measured as Titre)","description":"Anti-semaglutide antibodies level measured as titre at week 33 is presented.","populationDescription":"Safety analysis set included all participants who are exposed to study intervention. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Titre","timeFrame":"At week 33","groups":[{"id":"OG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."},{"id":"OG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.00","spread":"0.00"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From the time of first dosing (week 0) to end of study (week 33)","description":"All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.","eventGroups":[{"id":"EG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.","deathsNumAffected":1,"deathsNumAtRisk":291,"seriousNumAffected":8,"seriousNumAtRisk":291,"otherNumAffected":64,"otherNumAtRisk":291},{"id":"EG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. 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