{"protocolSection":{"identificationModule":{"nctId":"NCT03856047","orgStudyIdInfo":{"id":"NN9838-4433"},"secondaryIdInfos":[{"id":"U1111-1214-0429","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2018-001945-14","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"2018","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2018"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.","officialTitle":"Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial."},"statusModule":{"statusVerifiedDate":"2024-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-03-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-03-02","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-25","type":"ACTUAL"},"studyFirstSubmitDate":"2019-02-25","studyFirstSubmitQcDate":"2019-02-25","studyFirstPostDateStruct":{"date":"2019-02-27","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-02-17","resultsFirstSubmitQcDate":"2023-07-17","resultsFirstPostDateStruct":{"date":"2023-07-18","type":"ACTUAL"},"dispFirstSubmitDate":"2021-02-18","dispFirstPostDateStruct":{"date":"2023-07-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-07-02","lastUpdatePostDateStruct":{"date":"2024-07-05","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 will look at the change in body weight in people taking NNC0174-0833, liraglutide and \"dummy\" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or \"dummy\" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor."},"conditionsModule":{"conditions":["Overweight","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":706,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"NNC0174-0833, 4.5 mg","type":"EXPERIMENTAL","description":"Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.","interventionNames":["Drug: NNC0174-0833"]},{"label":"NNC0174-0833, 2.4 mg","type":"EXPERIMENTAL","description":"Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.","interventionNames":["Drug: NNC0174-0833"]},{"label":"NNC0174-0833, 1.2 mg","type":"EXPERIMENTAL","description":"Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.","interventionNames":["Drug: NNC0174-0833"]},{"label":"NNC0174-0833, 0.6 mg","type":"EXPERIMENTAL","description":"Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.","interventionNames":["Drug: NNC0174-0833"]},{"label":"NNC0174-0833 0.3 mg","type":"EXPERIMENTAL","description":"Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.","interventionNames":["Drug: NNC0174-0833"]},{"label":"Placebo 2.4 mg (NNC0174-0833)","type":"PLACEBO_COMPARATOR","description":"Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.","interventionNames":["Drug: Placebo (NNC0174-0833)"]},{"label":"Placebo 4.5 mg (NNC0174-0833)","type":"PLACEBO_COMPARATOR","description":"Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.","interventionNames":["Drug: Placebo (NNC0174-0833)"]},{"label":"Placebo 1.2 mg (NNC0174-0833)","type":"PLACEBO_COMPARATOR","description":"Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.","interventionNames":["Drug: Placebo (NNC0174-0833)"]},{"label":"Placebo 0.6 mg (NNC0174-0833)","type":"PLACEBO_COMPARATOR","description":"Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.","interventionNames":["Drug: Placebo (NNC0174-0833)"]},{"label":"Placebo 0.3 mg (NNC0174-0833)","type":"PLACEBO_COMPARATOR","description":"Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.","interventionNames":["Drug: Placebo (NNC0174-0833)"]},{"label":"Liraglutide 3.0 mg","type":"ACTIVE_COMPARATOR","description":"Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.","interventionNames":["Drug: Liraglutide 3.0 mg"]},{"label":"Placebo 3.0 mg (Liraglutide)","type":"PLACEBO_COMPARATOR","description":"Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.","interventionNames":["Drug: Placebo (Liraglutide 3.0 mg)"]}],"interventions":[{"type":"DRUG","name":"NNC0174-0833","description":"Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.","armGroupLabels":["NNC0174-0833 0.3 mg","NNC0174-0833, 0.6 mg","NNC0174-0833, 1.2 mg","NNC0174-0833, 2.4 mg","NNC0174-0833, 4.5 mg"]},{"type":"DRUG","name":"Placebo (NNC0174-0833)","description":"Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.","armGroupLabels":["Placebo 0.3 mg (NNC0174-0833)","Placebo 0.6 mg (NNC0174-0833)","Placebo 1.2 mg (NNC0174-0833)","Placebo 2.4 mg (NNC0174-0833)","Placebo 4.5 mg (NNC0174-0833)"]},{"type":"DRUG","name":"Liraglutide 3.0 mg","description":"Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.","armGroupLabels":["Liraglutide 3.0 mg"]},{"type":"DRUG","name":"Placebo (Liraglutide 3.0 mg)","description":"Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.","armGroupLabels":["Placebo 3.0 mg (Liraglutide)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight (%)","description":"Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.","timeFrame":"From baseline (week 0) to week 26"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks","description":"Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.","timeFrame":"Week 26"},{"measure":"Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks","description":"Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.","timeFrame":"Week 26"},{"measure":"Change in Body Weight (Kg)","description":"Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol","description":"Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Triglycerides","description":"Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Glycosylated Haemoglobin (HbA1c) (%-Point)","description":"Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in HbA1c (mmol/Mol)","description":"Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Fasting Plasma Glucose (FPG) (mmol/L)","description":"Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in FPG (mg/dL)","description":"Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Fasting Insulin","description":"In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)","description":"Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)","description":"Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \\* insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","timeFrame":"From week 0 to week 32"},{"measure":"Number of Treatment-emergent Serious Adverse Events (TESAEs)","description":"An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","timeFrame":"From week 0 to week 32"},{"measure":"Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide","description":"Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. This endpoint is applicable only for the cagrilintide treatment arms.","timeFrame":"From week 0 to week 32"},{"measure":"Change in Diastolic Blood Pressure (DBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Systolic Blood Pressure (SBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Pulse","description":"Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in High Sensitivity C-reactive Protein (hsCRP)","description":"In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity","description":"Due to the assay development issue faced by the laboratory, the Plasminogen Activator Inhibitor-1 (PAI-1) activity (mg/L) was not performed in the study.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Renin Activity","description":"Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","timeFrame":"From baseline (week 0) to week 26"},{"measure":"Change in Aldosterone","description":"Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","timeFrame":"From baseline (week 0) to week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 18 years or older at the time of signing the informed consent.\n* Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').\n* BMI equal to 30.0 kg/m\\^2 or greater or BMI equal to 27.0 kg/m\\^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).\n\nExclusion Criteria:\n\n* HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Encompass Clinical Research","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"Nature Coast Clinical 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Centre Vojvodina, Clin. endocr., diab. and met. dis.","city":"Novi Sad","zip":"21000","country":"Serbia","geoPoint":{"lat":45.25167,"lon":19.83694}},{"facility":"FARMOVS (Pty) LTD","city":"Bloemfontein","state":"Free State","zip":"9300","country":"South Africa","geoPoint":{"lat":-29.12107,"lon":26.214}},{"facility":"Dr Wilhase's rooms","city":"Boksburg","state":"Gauteng","zip":"1466","country":"South Africa","geoPoint":{"lat":-26.21197,"lon":28.25958}},{"facility":"Dr R Dulabh","city":"Johannesburg","state":"Gauteng","zip":"1812","country":"South Africa","geoPoint":{"lat":-26.20227,"lon":28.04363}},{"facility":"Dr Vawda's site","city":"Durban","state":"KwaZulu-Natal","zip":"4091","country":"South Africa","geoPoint":{"lat":-29.8579,"lon":31.0292}},{"facility":"Dr J Reddy","city":"Durban","state":"KwaZulu-Natal","zip":"4450","country":"South Africa","geoPoint":{"lat":-29.8579,"lon":31.0292}},{"facility":"The Health Centre","city":"Bradford on Avon","zip":"BA15 1DQ","country":"United Kingdom","geoPoint":{"lat":51.34772,"lon":-2.25065}},{"facility":"Southmead Hospital","city":"Bristol","zip":"BS10 5NB","country":"United Kingdom","geoPoint":{"lat":51.45523,"lon":-2.59665}},{"facility":"WISDEM Centre","city":"Coventry","zip":"CV2 2DX","country":"United Kingdom","geoPoint":{"lat":52.40656,"lon":-1.51217}},{"facility":"University Hospital Aintree","city":"Liverpool","zip":"L9 7AL","country":"United Kingdom","geoPoint":{"lat":53.41058,"lon":-2.97794}},{"facility":"Guys Hospital","city":"London","zip":"SE1 9RT","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"UCL - Obesity","city":"London","zip":"WC1E 6JF","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}},{"facility":"Clifton Medical Centre","city":"Rotherham","zip":"S65 1DA","country":"United Kingdom","geoPoint":{"lat":53.43012,"lon":-1.35678}}]},"referencesModule":{"references":[{"pmid":"34798060","type":"RESULT","citation":"Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietilainen KH, Rubino D, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021 Dec 11;398(10317):2160-2172. doi: 10.1016/S0140-6736(21)01751-7. Epub 2021 Nov 16."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized in a 6:1 ratio between the active treatment (cagrilintide and liraglutide) arms and the placebo arms. The five different cagrilintide placebo arms and the one liraglutide placebo arm were pooled into one placebo group in the main analyses. Participants received the treatments as an adjunct to reduced-calorie diet and increased physical activity.","recruitmentDetails":"The trial was conducted at 57 sites in 10 countries as follows: Canada (5), Denmark (2), Finland (4), Ireland (1), Japan (3), Poland (3), Serbia (5), South Africa (5), United Kingdom (7), United States of America (22).","groups":[{"id":"FG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"FG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"FG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"FG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"FG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"FG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"FG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"100"},{"groupId":"FG002","numSubjects":"102"},{"groupId":"FG003","numSubjects":"102"},{"groupId":"FG004","numSubjects":"101"},{"groupId":"FG005","numSubjects":"99"},{"groupId":"FG006","numSubjects":"101"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"100"},{"groupId":"FG002","numSubjects":"102"},{"groupId":"FG003","numSubjects":"102"},{"groupId":"FG004","numSubjects":"101"},{"groupId":"FG005","numSubjects":"99"},{"groupId":"FG006","numSubjects":"101"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"100"},{"groupId":"FG002","numSubjects":"102"},{"groupId":"FG003","numSubjects":"102"},{"groupId":"FG004","numSubjects":"101"},{"groupId":"FG005","numSubjects":"99"},{"groupId":"FG006","numSubjects":"101"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"97"},{"groupId":"FG002","numSubjects":"98"},{"groupId":"FG003","numSubjects":"101"},{"groupId":"FG004","numSubjects":"94"},{"groupId":"FG005","numSubjects":"95"},{"groupId":"FG006","numSubjects":"95"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"7"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set included all randomised participants according to the intention-to-treat principle.","groups":[{"id":"BG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"BG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"BG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"BG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"BG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"BG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"BG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."},{"id":"BG007","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"101"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"102"},{"groupId":"BG003","value":"102"},{"groupId":"BG004","value":"101"},{"groupId":"BG005","value":"99"},{"groupId":"BG006","value":"101"},{"groupId":"BG007","value":"706"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.5","spread":"10.3"},{"groupId":"BG001","value":"53.2","spread":"11.0"},{"groupId":"BG002","value":"52.1","spread":"8.7"},{"groupId":"BG003","value":"52.7","spread":"9.8"},{"groupId":"BG004","value":"51.5","spread":"12.7"},{"groupId":"BG005","value":"51.5","spread":"9.3"},{"groupId":"BG006","value":"51.4","spread":"11.9"},{"groupId":"BG007","value":"52.3","spread":"10.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"75"},{"groupId":"BG004","value":"56"},{"groupId":"BG005","value":"65"},{"groupId":"BG006","value":"59"},{"groupId":"BG007","value":"436"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"39"},{"groupId":"BG003","value":"27"},{"groupId":"BG004","value":"45"},{"groupId":"BG005","value":"34"},{"groupId":"BG006","value":"42"},{"groupId":"BG007","value":"270"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"21"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"99"},{"groupId":"BG001","value":"99"},{"groupId":"BG002","value":"98"},{"groupId":"BG003","value":"100"},{"groupId":"BG004","value":"98"},{"groupId":"BG005","value":"94"},{"groupId":"BG006","value":"97"},{"groupId":"BG007","value":"685"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"75"},{"groupId":"BG003","value":"80"},{"groupId":"BG004","value":"83"},{"groupId":"BG005","value":"82"},{"groupId":"BG006","value":"71"},{"groupId":"BG007","value":"543"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"13"},{"groupId":"BG006","value":"17"},{"groupId":"BG007","value":"92"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"9"},{"groupId":"BG007","value":"45"}]}]},{"title":"American Indian or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"2"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"24"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Weight (%)","description":"Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of body weight","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"98"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"95"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.1","spread":"3.9"},{"groupId":"OG001","value":"-6.9","spread":"5.4"},{"groupId":"OG002","value":"-8.5","spread":"5.4"},{"groupId":"OG003","value":"-9.5","spread":"6.2"},{"groupId":"OG004","value":"-10.8","spread":"5.5"},{"groupId":"OG005","value":"-8.5","spread":"5.6"},{"groupId":"OG006","value":"-3.0","spread":"5.2"}]}]}],"analyses":[{"groupIds":["OG000","OG006"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"0.0002","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-2.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.58","ciUpperLimit":"-1.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.81"},{"groupIds":["OG001","OG006"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-3.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.38","ciUpperLimit":"-2.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.82"},{"groupIds":["OG002","OG006"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-6.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.77","ciUpperLimit":"-4.36","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.87"},{"groupIds":["OG003","OG006"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-6.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.28","ciUpperLimit":"-5.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.81"},{"groupIds":["OG004","OG006"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-7.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.42","ciUpperLimit":"-6.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.83"},{"groupIds":["OG005","OG006"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-5.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.61","ciUpperLimit":"-4.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.83"},{"groupIds":["OG000","OG005"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"0.0003","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"2.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.38","ciUpperLimit":"4.60","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.82"},{"groupIds":["OG001","OG005"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"0.0082","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"2.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.57","ciUpperLimit":"3.84","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.83"},{"groupIds":["OG002","OG005"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"0.9209","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.82","ciUpperLimit":"1.64","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.88"},{"groupIds":["OG003","OG005"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"0.3960","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-0.70","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.33","ciUpperLimit":"0.92","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.83"},{"groupIds":["OG004","OG005"],"groupDescription":"Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.","nonInferiorityType":"SUPERIORITY","pValue":"0.0316","statisticalMethod":"ANCOVA","paramType":"Treatment difference (%-points)","paramValue":"-1.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.46","ciUpperLimit":"-0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.84"}]},{"type":"SECONDARY","title":"Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks","description":"Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"80"},{"groupId":"OG004","value":"80"},{"groupId":"OG005","value":"78"},{"groupId":"OG006","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57.47"},{"groupId":"OG001","value":"61.98"},{"groupId":"OG002","value":"75.84"},{"groupId":"OG003","value":"74.12"},{"groupId":"OG004","value":"88.74"},{"groupId":"OG005","value":"76.16"},{"groupId":"OG006","value":"30.90"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks","description":"Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"80"},{"groupId":"OG004","value":"80"},{"groupId":"OG005","value":"78"},{"groupId":"OG006","value":"79"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.28"},{"groupId":"OG001","value":"24.06"},{"groupId":"OG002","value":"35.79"},{"groupId":"OG003","value":"43.97"},{"groupId":"OG004","value":"53.49"},{"groupId":"OG005","value":"39.43"},{"groupId":"OG006","value":"10.44"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Kg)","description":"Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms (kg)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"98"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"95"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.6","spread":"4.3"},{"groupId":"OG001","value":"-7.1","spread":"5.6"},{"groupId":"OG002","value":"-9.0","spread":"6.3"},{"groupId":"OG003","value":"-10.1","spread":"6.7"},{"groupId":"OG004","value":"-11.8","spread":"6.8"},{"groupId":"OG005","value":"-9.1","spread":"6.4"},{"groupId":"OG006","value":"-3.2","spread":"5.8"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimeters (cm)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"98"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"5.0"},{"groupId":"OG001","value":"-6.2","spread":"5.9"},{"groupId":"OG002","value":"-7.7","spread":"7.1"},{"groupId":"OG003","value":"-8.1","spread":"7.1"},{"groupId":"OG004","value":"-9.5","spread":"6.1"},{"groupId":"OG005","value":"-7.4","spread":"5.8"},{"groupId":"OG006","value":"-3.4","spread":"5.7"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milligrams per deciliter (mg/dL)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.9","spread":"27.8"},{"groupId":"OG001","value":"-1.8","spread":"22.1"},{"groupId":"OG002","value":"-3.1","spread":"24.9"},{"groupId":"OG003","value":"-2.9","spread":"26.7"},{"groupId":"OG004","value":"-5.4","spread":"22.1"},{"groupId":"OG005","value":"-9.4","spread":"26.4"},{"groupId":"OG006","value":"0.1","spread":"22.8"}]}]}]},{"type":"SECONDARY","title":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"6.1"},{"groupId":"OG001","value":"1.9","spread":"6.9"},{"groupId":"OG002","value":"1.1","spread":"7.3"},{"groupId":"OG003","value":"1.8","spread":"5.6"},{"groupId":"OG004","value":"2.6","spread":"6.9"},{"groupId":"OG005","value":"0.8","spread":"6.3"},{"groupId":"OG006","value":"0.1","spread":"7.0"}]}]}]},{"type":"SECONDARY","title":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.2","spread":"24.0"},{"groupId":"OG001","value":"-0.3","spread":"19.6"},{"groupId":"OG002","value":"-0.5","spread":"19.8"},{"groupId":"OG003","value":"-0.9","spread":"22.1"},{"groupId":"OG004","value":"-2.7","spread":"19.2"},{"groupId":"OG005","value":"-5.4","spread":"22.9"},{"groupId":"OG006","value":"-1.0","spread":"21.5"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol","description":"Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.8","spread":"9.1"},{"groupId":"OG001","value":"-3.4","spread":"11.9"},{"groupId":"OG002","value":"-3.6","spread":"14.1"},{"groupId":"OG003","value":"-3.8","spread":"9.4"},{"groupId":"OG004","value":"-5.4","spread":"10.2"},{"groupId":"OG005","value":"-4.9","spread":"8.6"},{"groupId":"OG006","value":"0.9","spread":"15.6"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides","description":"Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"97"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.29","spread":"47.51"},{"groupId":"OG001","value":"-16.25","spread":"67.59"},{"groupId":"OG002","value":"-17.98","spread":"71.24"},{"groupId":"OG003","value":"-19.24","spread":"47.30"},{"groupId":"OG004","value":"-30.35","spread":"58.35"},{"groupId":"OG005","value":"-25.42","spread":"45.40"},{"groupId":"OG006","value":"8.17","spread":"103.36"}]}]}]},{"type":"SECONDARY","title":"Change in Glycosylated Haemoglobin (HbA1c) (%-Point)","description":"Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"95"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.2"},{"groupId":"OG001","value":"-0.1","spread":"0.2"},{"groupId":"OG002","value":"-0.1","spread":"0.3"},{"groupId":"OG003","value":"-0.1","spread":"0.3"},{"groupId":"OG004","value":"-0.1","spread":"0.2"},{"groupId":"OG005","value":"-0.3","spread":"0.2"},{"groupId":"OG006","value":"-0.1","spread":"0.2"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (mmol/Mol)","description":"Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/mol","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"95"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"95"},{"groupId":"OG005","value":"95"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"2.4"},{"groupId":"OG001","value":"-0.6","spread":"2.2"},{"groupId":"OG002","value":"-0.8","spread":"3.0"},{"groupId":"OG003","value":"-1.0","spread":"2.9"},{"groupId":"OG004","value":"-1.2","spread":"2.4"},{"groupId":"OG005","value":"-2.9","spread":"2.7"},{"groupId":"OG006","value":"-0.6","spread":"2.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG) (mmol/L)","description":"Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"95"},{"groupId":"OG002","value":"94"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"96"},{"groupId":"OG005","value":"94"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.6"},{"groupId":"OG001","value":"0.0","spread":"0.5"},{"groupId":"OG002","value":"-0.2","spread":"0.5"},{"groupId":"OG003","value":"0.0","spread":"0.7"},{"groupId":"OG004","value":"-0.2","spread":"1.0"},{"groupId":"OG005","value":"-0.5","spread":"0.7"},{"groupId":"OG006","value":"0.0","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Change in FPG (mg/dL)","description":"Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"95"},{"groupId":"OG002","value":"94"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"96"},{"groupId":"OG005","value":"94"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"10.1"},{"groupId":"OG001","value":"-0.6","spread":"8.9"},{"groupId":"OG002","value":"-3.2","spread":"9.7"},{"groupId":"OG003","value":"0.0","spread":"12.0"},{"groupId":"OG004","value":"-3.7","spread":"18.4"},{"groupId":"OG005","value":"-9.5","spread":"12.4"},{"groupId":"OG006","value":"-0.5","spread":"11.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Insulin","description":"In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Number analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Picomoles per liter (pmol/L)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"99"},{"groupId":"OG005","value":"99"},{"groupId":"OG006","value":"101"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"99"},{"groupId":"OG005","value":"99"},{"groupId":"OG006","value":"101"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"103.88","spread":"6.62"},{"groupId":"OG001","value":"97.43","spread":"6.73"},{"groupId":"OG002","value":"96.44","spread":"5.91"},{"groupId":"OG003","value":"90.05","spread":"4.70"},{"groupId":"OG004","value":"109.99","spread":"8.23"},{"groupId":"OG005","value":"95.80","spread":"5.73"},{"groupId":"OG006","value":"105.77","spread":"7.06"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"92"},{"groupId":"OG003","value":"94"},{"groupId":"OG004","value":"94"},{"groupId":"OG005","value":"88"},{"groupId":"OG006","value":"85"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"93.07","spread":"6.44"},{"groupId":"OG001","value":"82.98","spread":"5.02"},{"groupId":"OG002","value":"79.39","spread":"4.53"},{"groupId":"OG003","value":"71.22","spread":"4.04"},{"groupId":"OG004","value":"78.67","spread":"5.42"},{"groupId":"OG005","value":"79.00","spread":"5.46"},{"groupId":"OG006","value":"86.55","spread":"5.59"}]}]}]},{"type":"SECONDARY","title":"Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)","description":"Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change of HOMA-IR","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"94"},{"groupId":"OG003","value":"99"},{"groupId":"OG004","value":"96"},{"groupId":"OG005","value":"93"},{"groupId":"OG006","value":"94"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"5.83"},{"groupId":"OG001","value":"-0.60","spread":"8.42"},{"groupId":"OG002","value":"-1.09","spread":"3.37"},{"groupId":"OG003","value":"-0.72","spread":"1.94"},{"groupId":"OG004","value":"-2.12","spread":"7.32"},{"groupId":"OG005","value":"-0.91","spread":"2.38"},{"groupId":"OG006","value":"-0.71","spread":"7.10"}]}]}]},{"type":"SECONDARY","title":"Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)","description":"Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \\* insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.","populationDescription":"The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of Beta Cell Function","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"95"},{"groupId":"OG002","value":"94"},{"groupId":"OG003","value":"96"},{"groupId":"OG004","value":"95"},{"groupId":"OG005","value":"89"},{"groupId":"OG006","value":"93"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.7","spread":"94.1"},{"groupId":"OG001","value":"-20.0","spread":"136.9"},{"groupId":"OG002","value":"-18.3","spread":"89.8"},{"groupId":"OG003","value":"-29.9","spread":"54.8"},{"groupId":"OG004","value":"-39.7","spread":"101.2"},{"groupId":"OG005","value":"16.3","spread":"75.1"},{"groupId":"OG006","value":"-26.0","spread":"122.6"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From week 0 to week 32","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"101"},{"groupId":"OG005","value":"99"},{"groupId":"OG006","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"361"},{"groupId":"OG003","value":"449"},{"groupId":"OG004","value":"460"},{"groupId":"OG005","value":"470"},{"groupId":"OG006","value":"276"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Serious Adverse Events (TESAEs)","description":"An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From week 0 to week 32","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"101"},{"groupId":"OG005","value":"99"},{"groupId":"OG006","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide","description":"Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. This endpoint is applicable only for the cagrilintide treatment arms.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to week 32","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"75"},{"groupId":"OG004","value":"75"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure (DBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeter of mercury (mmHg)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"68"},{"groupId":"OG005","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"5.9"},{"groupId":"OG001","value":"0.8","spread":"5.0"},{"groupId":"OG002","value":"-1.3","spread":"6.0"},{"groupId":"OG003","value":"-1.2","spread":"5.5"},{"groupId":"OG004","value":"-1.8","spread":"6.3"},{"groupId":"OG005","value":"-2.6","spread":"5.5"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure (SBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"68"},{"groupId":"OG005","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.9","spread":"8.7"},{"groupId":"OG001","value":"-0.9","spread":"8.1"},{"groupId":"OG002","value":"-4.9","spread":"9.7"},{"groupId":"OG003","value":"-5.0","spread":"8.4"},{"groupId":"OG004","value":"-6.2","spread":"8.5"},{"groupId":"OG005","value":"-3.8","spread":"7.1"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"91"},{"groupId":"OG002","value":"92"},{"groupId":"OG003","value":"94"},{"groupId":"OG004","value":"95"},{"groupId":"OG005","value":"88"},{"groupId":"OG006","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.1","spread":"8.4"},{"groupId":"OG001","value":"-0.6","spread":"8.4"},{"groupId":"OG002","value":"-1.2","spread":"9.1"},{"groupId":"OG003","value":"-2.0","spread":"10.2"},{"groupId":"OG004","value":"-4.5","spread":"9.2"},{"groupId":"OG005","value":"1.6","spread":"9.1"},{"groupId":"OG006","value":"-0.1","spread":"8.5"}]}]}]},{"type":"SECONDARY","title":"Change in High Sensitivity C-reactive Protein (hsCRP)","description":"In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Number analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milligrams per liter (mg/L)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"101"},{"groupId":"OG005","value":"99"},{"groupId":"OG006","value":"101"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"102"},{"groupId":"OG003","value":"102"},{"groupId":"OG004","value":"101"},{"groupId":"OG005","value":"99"},{"groupId":"OG006","value":"101"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.5","spread":"6.7"},{"groupId":"OG001","value":"4.6","spread":"3.9"},{"groupId":"OG002","value":"4.5","spread":"5.8"},{"groupId":"OG003","value":"5.8","spread":"7.2"},{"groupId":"OG004","value":"5.4","spread":"7.5"},{"groupId":"OG005","value":"4.7","spread":"4.1"},{"groupId":"OG006","value":"4.6","spread":"6.0"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"92"},{"groupId":"OG003","value":"94"},{"groupId":"OG004","value":"94"},{"groupId":"OG005","value":"88"},{"groupId":"OG006","value":"85"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"3.5"},{"groupId":"OG001","value":"3.4","spread":"3.0"},{"groupId":"OG002","value":"4.6","spread":"8.8"},{"groupId":"OG003","value":"4.0","spread":"5.5"},{"groupId":"OG004","value":"3.4","spread":"4.0"},{"groupId":"OG005","value":"3.5","spread":"3.4"},{"groupId":"OG006","value":"3.9","spread":"5.3"}]}]}]},{"type":"SECONDARY","title":"Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity","description":"Due to the assay development issue faced by the laboratory, the Plasminogen Activator Inhibitor-1 (PAI-1) activity (mg/L) was not performed in the study.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.","reportingStatus":"POSTED","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"type":"SECONDARY","title":"Change in Renin Activity","description":"Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms per milliliter per hour","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"92"},{"groupId":"OG003","value":"92"},{"groupId":"OG004","value":"91"},{"groupId":"OG005","value":"84"},{"groupId":"OG006","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"12"},{"groupId":"OG001","value":"0","spread":"4"},{"groupId":"OG002","value":"1","spread":"9"},{"groupId":"OG003","value":"1","spread":"10"},{"groupId":"OG004","value":"1","spread":"8"},{"groupId":"OG005","value":"0","spread":"5"},{"groupId":"OG006","value":"0","spread":"5"}]}]}]},{"type":"SECONDARY","title":"Change in Aldosterone","description":"Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","populationDescription":"The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms per deciliter (ng/dL)","timeFrame":"From baseline (week 0) to week 26","groups":[{"id":"OG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector."},{"id":"OG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26)."},{"id":"OG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26)."},{"id":"OG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26)."},{"id":"OG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26)."},{"id":"OG006","title":"Pooled Placebo","description":"Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"92"},{"groupId":"OG003","value":"94"},{"groupId":"OG004","value":"94"},{"groupId":"OG005","value":"88"},{"groupId":"OG006","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"5.4"},{"groupId":"OG001","value":"0.8","spread":"6.3"},{"groupId":"OG002","value":"0.7","spread":"5.2"},{"groupId":"OG003","value":"2.2","spread":"7.1"},{"groupId":"OG004","value":"1.1","spread":"5.9"},{"groupId":"OG005","value":"1.0","spread":"8.2"},{"groupId":"OG006","value":"0.5","spread":"5.1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From week 0 to week 32 Results are based on the safety analysis set which included all randomised participants exposed to at least one dose of randomised treatment.","description":"All presented adverse events are treatment emergent adverse events (TEAEs). TEAE is defined as an event that had onset date during the on-treatment period. On-treatment period was from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.","eventGroups":[{"id":"EG000","title":"Cagrilintide 0.3 mg","description":"Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.","deathsNumAffected":0,"deathsNumAtRisk":101,"seriousNumAffected":6,"seriousNumAtRisk":101,"otherNumAffected":59,"otherNumAtRisk":101},{"id":"EG001","title":"Cagrilintide 0.6 mg","description":"Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.","deathsNumAffected":0,"deathsNumAtRisk":100,"seriousNumAffected":2,"seriousNumAtRisk":100,"otherNumAffected":58,"otherNumAtRisk":100},{"id":"EG002","title":"Cagrilintide 1.2 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26).","deathsNumAffected":0,"deathsNumAtRisk":102,"seriousNumAffected":7,"seriousNumAtRisk":102,"otherNumAffected":72,"otherNumAtRisk":102},{"id":"EG003","title":"Cagrilintide 2.4 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26).","deathsNumAffected":0,"deathsNumAtRisk":102,"seriousNumAffected":3,"seriousNumAtRisk":102,"otherNumAffected":62,"otherNumAtRisk":102},{"id":"EG004","title":"Cagrilintide 4.5 mg","description":"Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26).","deathsNumAffected":0,"deathsNumAtRisk":101,"seriousNumAffected":4,"seriousNumAtRisk":101,"otherNumAffected":76,"otherNumAtRisk":101},{"id":"EG005","title":"Liraglutide 3.0 mg","description":"Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. 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