protocolSection identificationModule nctId: NCT06388187, orgStudyIdInfo id: NN9838-7749, secondaryIdInfos id: U1111-1298-3451, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2023-509273-24, type: OTHER, domain: European Medical Agency (EMA), briefTitle: A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-24, primaryCompletionDateStruct date: 2026-02-27, completionDateStruct date: 2026-04-10, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Relative change in body weight, primaryOutcomes measure: Achievement of ≥5% weight reduction, secondaryOutcomes measure: Achievement of ≥10% weight reduction, secondaryOutcomes measure: Achievement of ≥15% weight reduction, secondaryOutcomes measure: Achievement of ≥20% weight reduction, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Ratio to baseline in lipids: Total cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Triglycerides, secondaryOutcomes measure: Ratio to baseline in lipids: Free fatty acids, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aurora FDRC Inc., city: Costa Mesa, state: California, zip: 92627, country: United States, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Clinical Trial Res Assoc,Inc, city: Plantation, state: Florida, zip: 33324, country: United States, geoPoint lat: 26.13421, lon: -80.23184, locations facility: Midwest Inst For Clin Res, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Accellacare, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Velocity Clinical Res-Dallas, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Washington Cntr Weight Mgmt, city: Arlington, state: Virginia, zip: 22206, country: United States, geoPoint lat: 38.88101, lon: -77.10428, locations facility: Capital Clin Res Ctr,LLC, city: Olympia, state: Washington, zip: 98502, country: United States, geoPoint lat: 47.03787, lon: -122.9007, locations facility: Ocean West Research Clinic, city: Surrey, state: British Columbia, zip: V3Z 2N6, country: Canada, geoPoint lat: 49.10635, lon: -122.82509, locations facility: Nova Scotia Health Authority, city: Halifax, state: Nova Scotia, zip: B3H 1V7, country: Canada, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Wharton Med Clin Trials, city: Hamilton, state: Ontario, zip: L8L 5G8, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Hospices Civils de Lyon-Hopital Lyon Sud-1, city: Pierre-Benite, zip: 69310, country: France, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, city: Saint Herblain, zip: 44800, country: France, geoPoint lat: 47.21765, lon: -1.64841, locations facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1, city: Toulouse Cedex 9, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: InnoDiab Forschung GmbH, city: Essen, zip: 45136, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Wendisch/Dahl Hamburg, city: Hamburg, zip: 22607, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: AmBeNet GmbH, city: Leipzig, zip: 04107, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, city: Münster, zip: 48145, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann, city: Witten, zip: 58455, country: Germany, geoPoint lat: 51.44362, lon: 7.35258, locations facility: The Health Centre, city: Bradford-on-Avon, zip: BA15 1DQ, country: United Kingdom, geoPoint lat: 51.34772, lon: -2.25065, locations facility: Southmead Hospital, city: Bristol, zip: BS10 5NB, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Addenbrooke's Hospital_Cambridge, city: Cambridge, zip: CB2 0QQ, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: WISDEM Centre, city: Coventry, zip: CV2 2DX, country: United Kingdom, geoPoint lat: 52.40656, lon: -1.51217, locations facility: The Staploe Medical Centre, city: Soham, zip: CB7 5JD, country: United Kingdom, geoPoint lat: 52.33543, lon: 0.33654, locations facility: Joint Clinical Research Facility - Swansea, city: Swansea, zip: SA2 8PP, country: United Kingdom, geoPoint lat: 51.62079, lon: -3.94323, hasResults: False