{"protocolSection":{"identificationModule":{"nctId":"NCT05891496","orgStudyIdInfo":{"id":"NN6535-7519"},"secondaryIdInfos":[{"id":"U1111-1283-8743","type":"OTHER","domain":"World Health Organisation (WHO)"},{"id":"2022-003384-24","type":"EUDRACT_NUMBER"},{"id":"2023-506825-13","type":"OTHER","domain":"EU CT Number"},{"id":"2023","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2023"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease","officialTitle":"A Randomised Double-blind Placebo-controlled Clinical Study Investigating the Effects of Semaglutide s.c. Once-weekly Versus Placebo on Central and Peripheral Inflammation in Participants With Alzheimer's Disease"},"statusModule":{"statusVerifiedDate":"2026-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-06-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-08-19","type":"ACTUAL"},"completionDateStruct":{"date":"2025-09-08","type":"ACTUAL"},"studyFirstSubmitDate":"2023-05-29","studyFirstSubmitQcDate":"2023-05-29","studyFirstPostDateStruct":{"date":"2023-06-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-08-04","resultsFirstSubmitQcDate":"2026-02-05","resultsFirstPostDateStruct":{"date":"2026-02-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-08-17","lastUpdatePostDateStruct":{"date":"2026-08-18","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 is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. This study will help us understand whether semaglutide can also be used for the treatment of Alzheimer's disease. The study will last for about 77 weeks. In the first 12 weeks of treatment, participants will either get semaglutide (active medicine) or placebo (inactive dummy medicine). Which treatment participants get is decided by chance. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide. Participants must have a study partner, who is willing to take part in the study. Participants will get study medicine in a pen injector. The study partner will need to inject the study medicine into the skin of participant's stomach, thigh or upper arm once every week."},"conditionsModule":{"conditions":["Alzheimers Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":23,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Study intervention period 1","type":"EXPERIMENTAL","description":"Participants will receive either semaglutide or placebo matched to semaglutide once-weekly subcutaneous (s.c.) injections for 12 weeks as an add on therapy to standard of care. Participants initially received 0.25 milligram (mg) once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (1.0 mg) was reached: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12).","interventionNames":["Drug: Semaglutide","Drug: Placebo"]},{"label":"Study intervention period 2","type":"PLACEBO_COMPARATOR","description":"All participants will receive 1.0 mg semaglutide s.c. injections once weekly for 52 weeks during study intervention period 2 as an add-on therapy to standard of care. Participants randomised to semaglutide s.c. 1.0 mg during study intervention period 1 remained on 1.0 mg target maintenance dose for 52 weeks from weeks 12-64. Participants initially randomised to placebo during study intervention period 1 will receive semaglutide s.c. in dose escalation fashion for 8 weeks (0.25 mg from weeks 12-16 and 0.5 mg from weeks 16-20) followed by a maintenance period from weeks 20-64 at dose 1.0 mg.","interventionNames":["Drug: Semaglutide"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Semagllutide will be administered once weekly subcutaneously.","armGroupLabels":["Study intervention period 1","Study intervention period 2"]},{"type":"DRUG","name":"Placebo","description":"Placebo matched to semaglutide will be administered once weekly subcutaneously.","armGroupLabels":["Study intervention period 1"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])","description":"Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).","timeFrame":"Baseline (week 0), week 12"},{"measure":"Change in Gene Expression Assessed by scRNAseq (Cells in Blood)","description":"Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes.","timeFrame":"Baseline (week 0), week 12"}],"secondaryOutcomes":[{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment period.","timeFrame":"From baseline (week 0) to week 12"},{"measure":"Number of TEAEs","timeFrame":"From baseline (week 0) to week 64"},{"measure":"Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis","timeFrame":"From week 4 to week 64"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent\n* Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria\n* Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)\n* Amyloid positivity established with either historical amyloid positron emission tomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSF Aβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)\n* Treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)\n\nExclusion Criteria:\n\n* Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by local read (example cerebral large-vessel disease \\[large vessel (cortical) infarcts greater than 10 millimeter (mm) in diameter\\], prior macro-haemorrhage \\[greater than 1centimeter cube (cm\\^3)\\], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus)\n* Brain MRI scan suggestive of significant small vessel pathology confirmed by local read and defined as greater than 1 lacunar infarct and/or white matter hyperintensity (WMH) Fazekas13 scale greater than 2, (white matter \\[WM\\] greater than 20 mm) in the deep white matter and periventricular regions\n* History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Any other medical condition that would require use of systemic corticosteroids or immunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)\n* Received a vaccine product (including booster) 4 weeks prior to screening (visit 1) or expected to receive a vaccine product (including booster) before visit 5\n* Use of any systemic immunomodulating drugs (small molecules and/or biologics) in the last 12 months prior to screening (visit 1) or anticipated use of such drugs during study intervention period 1 (i.e., during the first 12 weeks of treatment until visit 5), such as corticosteroids for systemic use, immunostimulants and immunosuppressants","healthyVolunteers":false,"sex":"ALL","minimumAge":"55 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 2834)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Banner Sun Health Research Institute","city":"Sun City","state":"Arizona","zip":"85351","country":"United States","geoPoint":{"lat":33.59754,"lon":-112.27182}},{"facility":"Brain Matters Research","city":"Delray Beach","state":"Florida","zip":"33445","country":"United States","geoPoint":{"lat":26.46146,"lon":-80.07282}},{"facility":"Ottawa Memory Clinic","city":"Ottawa","state":"Ontario","zip":"K1Z 1G3","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}},{"facility":"Memory Program","city":"Toronto","state":"Ontario","zip":"M3B2S7","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"Rigshospitalet - afsnit 8015 Hukommelsesklinikken","city":"København Ø","zip":"2100","country":"Denmark","geoPoint":{"lat":55.70968,"lon":12.57862}},{"facility":"Rigshospitalet - afsnit 8015","city":"København Ø","zip":"2100","country":"Denmark","geoPoint":{"lat":55.70968,"lon":12.57862}},{"facility":"Azienda Ospedaliera Spedali Civili di Brescia","city":"Brescia","zip":"25123","country":"Italy","geoPoint":{"lat":45.53558,"lon":10.21472}},{"facility":"Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia","city":"Perugia","zip":"06132","country":"Italy","geoPoint":{"lat":43.1122,"lon":12.38878}},{"facility":"Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser","city":"Perugia","zip":"06132","country":"Italy","geoPoint":{"lat":43.1122,"lon":12.38878}},{"facility":"Fondazione Santa Lucia IRCCS","city":"Roma","zip":"00179","country":"Italy","geoPoint":{"lat":44.99364,"lon":11.10642}},{"facility":"Karolinska Universitetssjukhuset, Huddinge","city":"Stockholm","zip":"141 86","country":"Sweden","geoPoint":{"lat":59.32938,"lon":18.06871}},{"facility":"Centre de la Mémoire","city":"Geneva","zip":"1205","country":"Switzerland","geoPoint":{"lat":46.20222,"lon":6.14569}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants with mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer's type were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of once weekly semaglutide or placebo matched to semaglutide. The final data for outcome measures 1,2 and 3 are reported with no further updates. Adverse events are presented for period 1 + period 2.","recruitmentDetails":"The trial was conducted at 7 sites in 5 countries (Canada, Denmark, Sweden, Switzerland and the United States).","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached."},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks."},{"id":"FG002","title":"Placebo to Semaglutide","description":"Participants who initially received placebo was administered with semaglutide every 4 weeks in a dose escalation manner."}],"periods":[{"title":"Period 1: 12 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Period 2: 52 Weeks","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Ongoing","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Semaglutide","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached."},{"id":"BG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"23"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"65.8","spread":"5.4"},{"groupId":"BG001","value":"69.3","spread":"4.1"},{"groupId":"BG002","value":"67.6","spread":"5.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"23"}]},{"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":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"23"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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 Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])","description":"Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).","populationDescription":"Full analysis set (FAS) comprised all randomised participants. Here, Overall 'Number of Participants Analysed' refers to the number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Differentially expressed genes","timeFrame":"Baseline (week 0), week 12","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41.25","spread":"29.68"},{"groupId":"OG001","value":"21.00","spread":"25.70"}]}]}]},{"type":"PRIMARY","title":"Change in Gene Expression Assessed by scRNAseq (Cells in Blood)","description":"Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes.","populationDescription":"FAS comprised all randomised participants. Here, Overall 'Number of Participants Analysed' refers to the number of participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Differentially expressed genes","timeFrame":"Baseline (week 0), week 12","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.00","spread":"5.97"},{"groupId":"OG001","value":"16.50","spread":"15.86"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment period.","populationDescription":"Safety analysis set (SAS) included all participants exposed to study intervention.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to week 12","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"8"}]}]}]},{"type":"SECONDARY","title":"Number of TEAEs","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2026-09","timeFrame":"From baseline (week 0) to week 64","denomUnitsSelected":"Participants"},{"type":"SECONDARY","title":"Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis","reportingStatus":"NOT_POSTED","anticipatedPostingDate":"2026-09","timeFrame":"From week 4 to week 64","denomUnitsSelected":"Participants"}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline (week 0) to end of study (week 69)","description":"All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.","eventGroups":[{"id":"EG000","title":"Semaglutide Period 1","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":9,"otherNumAtRisk":11},{"id":"EG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":12,"seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":5,"otherNumAtRisk":12},{"id":"EG002","title":"Semaglutide Period 2","description":"Participants from semaglutide period 1 arm received once weekly s.c. injection of maintenance dose semaglutide and participants from placebo arm received s.c. administration of semaglutide in dose escalation manner until the maintenance dose was reached up to 64 weeks.","deathsNumAffected":1,"deathsNumAtRisk":22,"seriousNumAffected":1,"seriousNumAtRisk":22,"otherNumAffected":15,"otherNumAtRisk":22}],"seriousEvents":[{"term":"Non-Hodgkin's lymphoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":22}]}],"otherEvents":[{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":22}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":12},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":22}]},{"term":"Catarrh","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":22}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":22}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":5,"numAffected":5,"numAtRisk":22}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":22}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":22}]},{"term":"Eczema","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 28","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":12},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":22}]},{"term":"Eosinophilia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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