{"protocolSection":{"identificationModule":{"nctId":"NCT04982575","orgStudyIdInfo":{"id":"NN9838-4862"},"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2025-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-08-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-07-07","type":"ACTUAL"},"completionDateStruct":{"date":"2022-07-07","type":"ACTUAL"},"studyFirstSubmitDate":"2021-07-16","studyFirstSubmitQcDate":"2021-07-28","studyFirstPostDateStruct":{"date":"2021-07-29","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-07-06","resultsFirstSubmitQcDate":"2023-07-06","resultsFirstPostDateStruct":{"date":"2023-07-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-05","lastUpdatePostDateStruct":{"date":"2025-12-23","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 looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.\n\nBefore a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.\n\nParticipants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.\n\nA dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.\n\nParticipants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.\n\nThe study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.\n\nAt 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).\n\nWomen who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period"},"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":92,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cagrilintide 2.4 mg and semaglutide 2.4 mg","type":"EXPERIMENTAL","description":"Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.","interventionNames":["Drug: Semaglutide 2.4 mg","Drug: Cagrilintide 2.4 mg"]},{"label":"Cagrilintide 2.4 mg and placebo (semaglutide)","type":"ACTIVE_COMPARATOR","description":"Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks","interventionNames":["Drug: Cagrilintide 2.4 mg","Drug: Placebo (semaglutide)"]},{"label":"Semaglutide 2.4 mg and Placebo (cagrilintide)","type":"ACTIVE_COMPARATOR","description":"Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks","interventionNames":["Drug: Semaglutide 2.4 mg","Drug: Placebo (cagrilintide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide 2.4 mg","description":"Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks","armGroupLabels":["Cagrilintide 2.4 mg and semaglutide 2.4 mg","Semaglutide 2.4 mg and Placebo (cagrilintide)"]},{"type":"DRUG","name":"Cagrilintide 2.4 mg","description":"Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks","armGroupLabels":["Cagrilintide 2.4 mg and placebo (semaglutide)","Cagrilintide 2.4 mg and semaglutide 2.4 mg"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly.\n\nParticipants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks","armGroupLabels":["Cagrilintide 2.4 mg and placebo (semaglutide)"]},{"type":"DRUG","name":"Placebo (cagrilintide)","description":"Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly.\n\nParticipants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks","armGroupLabels":["Semaglutide 2.4 mg and Placebo (cagrilintide)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications.","timeFrame":"Week 0, Week 32"}],"secondaryOutcomes":[{"measure":"Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"Week 0, Week 32"},{"measure":"Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Percenatge change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"Week 0, Week 32"},{"measure":"Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"Week 0, Week 32"},{"measure":"Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Change in FPG from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"Week 0, Week 32"},{"measure":"CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Change in mean glucose from baslline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"Week 0, Week 32"},{"measure":"Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Percentage of TAR greater than 10.0 mmol/L (greater than 180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range greater than 10.0 mmol/L (greater than 180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"At week 32"},{"measure":"Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Percentage of TIR 3.9-10.0 mmol/L (70-180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.","timeFrame":"At week 32"},{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a clinical trial participants administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.","timeFrame":"From baseline (week 0) to week 37"},{"measure":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)","description":"Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 37 are presented. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.","timeFrame":"From baseline (week 0) to week 37"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Female of non-childbearing potential or male\n* Age above or equal to 18 years at the time of signing informed consent\n* Body mass index (BMI) greater than or equal to 27.0 kg/m\\^2\n* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening\n* Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening\n* Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor\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* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m\\^2 by central laboratory at screening\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","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Uni of Alabama at Birmingham","city":"Birmingham","state":"Alabama","zip":"35233","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Valley Research","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Pacific Clinical Studies","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"Velocity Clin Res Los Angeles","city":"Los Angeles","state":"California","zip":"90017","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Encompass Clinical Research_Spring Valley","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"New West Physicians,Inc.","city":"Golden","state":"Colorado","zip":"80401","country":"United States","geoPoint":{"lat":39.75554,"lon":-105.2211}},{"facility":"FPA Clinical Research","city":"Kissimmee","state":"Florida","zip":"34741","country":"United States","geoPoint":{"lat":28.30468,"lon":-81.41667}},{"facility":"Florida Inst For Clin Res","city":"Orlando","state":"Florida","zip":"32825","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Clinical Trial Res Assoc,Inc","city":"Plantation","state":"Florida","zip":"33324","country":"United States","geoPoint":{"lat":26.13421,"lon":-80.23184}},{"facility":"Ellipsis Group","city":"Alpharetta","state":"Georgia","zip":"30022","country":"United States","geoPoint":{"lat":34.07538,"lon":-84.29409}},{"facility":"East West Med Res Inst","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Macoupin Research Group","city":"Gillespie","state":"Illinois","zip":"62033","country":"United States","geoPoint":{"lat":39.12977,"lon":-89.81954}},{"facility":"MD Medical Research","city":"Oxon Hill","state":"Maryland","zip":"20745","country":"United States","geoPoint":{"lat":38.80345,"lon":-76.9897}},{"facility":"PharmQuest Life Sciences LLC","city":"Greensboro","state":"North Carolina","zip":"27408","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"Accellacare","city":"Wilmington","state":"North Carolina","zip":"28401","country":"United States","geoPoint":{"lat":34.23556,"lon":-77.94604}},{"facility":"Lillestol Research LLC","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Plains Clinical Research Center, LLC_Fargo","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"Holston Medical Group","city":"Kingsport","state":"Tennessee","zip":"37660","country":"United States","geoPoint":{"lat":36.54843,"lon":-82.56182}},{"facility":"Velocity Clinical Res-Dallas","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"PlanIt Research, PLLC","city":"Houston","state":"Texas","zip":"77079","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"DCOL Ctr for Clin Res","city":"Longview","state":"Texas","zip":"75605","country":"United States","geoPoint":{"lat":32.5007,"lon":-94.74049}},{"facility":"Selma Medical Associates","city":"Winchester","state":"Virginia","zip":"22601-3834","country":"United States","geoPoint":{"lat":39.18566,"lon":-78.16333}},{"facility":"Capital Clin Res Ctr,LLC","city":"Olympia","state":"Washington","zip":"98502","country":"United States","geoPoint":{"lat":47.04491,"lon":-122.90169}}]},"referencesModule":{"references":[{"pmid":"37364590","type":"BACKGROUND","citation":"Frias JP, Deenadayalan S, Erichsen L, Knop FK, Lingvay I, Macura S, Mathieu C, Pedersen SD, Davies M. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023 Aug 26;402(10403):720-730. doi: 10.1016/S0140-6736(23)01163-7. Epub 2023 Jun 23."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"After randomisation, participants were to continue their pre-trial metformin and sodium-glucose co-transporter-2 (SGLT2) inhibitor background medication throughout the entire trial. The background metformin and SGLT2 inhibitor were to be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period unless glycaemic rescue treatment was needed or adjustment was required due to safety concerns.","recruitmentDetails":"The trial was conducted at 17 sites in the United States.","groups":[{"id":"FG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"FG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"FG002","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"31"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analyis set (FAS) included all randomized participants.","groups":[{"id":"BG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"BG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"BG002","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"92"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56","spread":"10"},{"groupId":"BG001","value":"62","spread":"7"},{"groupId":"BG002","value":"57","spread":"10"},{"groupId":"BG003","value":"58","spread":"9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"33"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"18"},{"groupId":"BG003","value":"59"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"29"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"18"},{"groupId":"BG003","value":"63"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","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"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"15"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"72"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications.","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 HbA1c","timeFrame":"Week 0, Week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Change from Baseline - in-trial","categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"0.9"},{"groupId":"OG001","value":"-1.9","spread":"1.0"}]}]},{"title":"Change from Baseline - on treatment without rescue","categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"0.9"},{"groupId":"OG001","value":"-2.0","spread":"1.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification.","nonInferiorityType":"OTHER","pValue":"0.2284","statisticalMethod":"Mixed Models Analysis","paramType":"Treatment difference","paramValue":"-0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.79","ciUpperLimit":"0.19"}]},{"type":"SECONDARY","title":"Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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 point of HbA1c","timeFrame":"Week 0, Week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"0.9"},{"groupId":"OG001","value":"-0.8","spread":"0.9"}]}]}]},{"type":"SECONDARY","title":"Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Percenatge change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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 body weight","timeFrame":"Week 0, Week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received Semaglutide 2.4 mg and 2.4 mg placebo (cagrilintide) once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.7","spread":"9.3"},{"groupId":"OG001","value":"-5.0","spread":"4.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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","timeFrame":"Week 0, Week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received Semaglutide 2.4 mg and 2.4 mg placebo (cagrilintide) once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.4","spread":"10.1"},{"groupId":"OG001","value":"-5.3","spread":"4.2"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Change in FPG from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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":"Millimoles per liter (mmol/L)","timeFrame":"Week 0, Week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.4","spread":"3.1"},{"groupId":"OG001","value":"-2.7","spread":"2.3"}]}]}]},{"type":"SECONDARY","title":"CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Change in mean glucose from baslline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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":"Millimoles per liter (mmol/l)","timeFrame":"Week 0, Week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.5","spread":"2.3"},{"groupId":"OG001","value":"-1.0","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Percentage of TAR greater than 10.0 mmol/L (greater than 180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range greater than 10.0 mmol/L (greater than 180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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 time","timeFrame":"At week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.3","spread":"15.7"},{"groupId":"OG001","value":"30.9","spread":"25.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Percentage of TIR 3.9-10.0 mmol/L (70-180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last 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 time","timeFrame":"At week 32","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"88.9","spread":"15.3"},{"groupId":"OG001","value":"68.9","spread":"25.1"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a clinical trial participants administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.","populationDescription":"Safety analysis set included all randomised participants and who take at least 1 dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to week 37","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG002","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"31"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"22"}]}]}]},{"type":"SECONDARY","title":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)","description":"Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 37 are presented. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.","populationDescription":"Safety analysis set included all randomised participants and who take at least 1 dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From baseline (week 0) to week 37","groups":[{"id":"OG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."},{"id":"OG002","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"31"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline (week 0) to week 37","description":"AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \\& ends at first date of any of following; date of last dose of trial product +35 days for AEs \\& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.","eventGroups":[{"id":"EG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).","deathsNumAffected":0,"deathsNumAtRisk":31,"seriousNumAffected":0,"seriousNumAtRisk":31,"otherNumAffected":18,"otherNumAtRisk":31},{"id":"EG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":4,"seriousNumAtRisk":30,"otherNumAffected":18,"otherNumAtRisk":30},{"id":"EG002","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 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), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).","deathsNumAffected":0,"deathsNumAtRisk":31,"seriousNumAffected":2,"seriousNumAtRisk":31,"otherNumAffected":18,"otherNumAtRisk":31}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":30},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":31}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 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