protocolSection identificationModule nctId: NCT06323174, orgStudyIdInfo id: NN9388-4895, secondaryIdInfos id: 2022-502677-42, type: OTHER, domain: European Medical Agency (EMA), secondaryIdInfos id: U1111-1283-0404, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise, acronym: REIMAGINE 1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-08-12, completionDateStruct date: 2025-11-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year., conditionsModule conditions: Type 2 Diabetes, 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: 180, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in glycated haemoglobin (HbA1c), secondaryOutcomes measure: Relative change in body weight, secondaryOutcomes measure: Number of participants who achieve greater than or equal to (>=) 10% body weight reduction, secondaryOutcomes measure: Number of participants who achieve >=15% body weight reduction, secondaryOutcomes measure: Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]), secondaryOutcomes measure: Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol), secondaryOutcomes measure: Change in Fasting Plasma Glucose (FPG), secondaryOutcomes measure: Number of participants who achieve >=5% body weight reduction, secondaryOutcomes measure: Number of participants who achieve >=20% body weight reduction, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in systolic blood pressure (SBP), secondaryOutcomes measure: Change in diastolic blood pressure (DBP), secondaryOutcomes measure: Ratio to baseline in high sensitivity C-reactive protein (hsCRP), 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, secondaryOutcomes measure: Ratio to baseline in lipids: Non-HDL cholesterol, secondaryOutcomes measure: Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication), secondaryOutcomes measure: Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo), secondaryOutcomes measure: Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score, secondaryOutcomes measure: Change in SF-36v2 score: Physical Component Summary score, secondaryOutcomes measure: Change in SF-36v2 score: Mental Component Summary score, secondaryOutcomes measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score, secondaryOutcomes measure: Change in leptin, secondaryOutcomes measure: Change in soluble leptin receptor, secondaryOutcomes measure: Number of Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter, secondaryOutcomes measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Research Institute_Huntington Park, status: RECRUITING, city: Huntington Park, state: California, zip: 90255, country: United States, geoPoint lat: 33.98168, lon: -118.22507, locations facility: Valley Clinical Trials, Inc., status: RECRUITING, city: Northridge, state: California, zip: 91325, country: United States, geoPoint lat: 34.22834, lon: -118.53675, locations facility: Southern California Dermatology, status: RECRUITING, city: Santa Ana, state: California, zip: 92701, country: United States, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Encore Medical Research LLC, status: RECRUITING, city: Hollywood, state: Florida, zip: 33021, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Alliance for Multispec Res, status: NOT_YET_RECRUITING, city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: Brigham & Women's Hospital, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Arcturus Healthcare, PLC, status: RECRUITING, city: Troy, state: Michigan, zip: 48098, country: United States, geoPoint lat: 42.60559, lon: -83.14993, locations facility: Holston Medical Group, status: RECRUITING, city: Kingsport, state: Tennessee, zip: 37660, country: United States, geoPoint lat: 36.54843, lon: -82.56182, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Northeast Clinical Research of San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78233, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Consano Clinical Research, LLC, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Consano Clinical Research, LLC, status: NOT_YET_RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Chinese People's Liberation Army General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Jiangsu University_Zhenjiang, status: NOT_YET_RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jinan Central Hospital, status: NOT_YET_RECRUITING, city: Ji'Nan, state: Shandong, zip: 250000, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Belinus Bt., status: NOT_YET_RECRUITING, city: Debrecen, state: Hajdu-Bihar Varmegye, zip: 4025, country: Hungary, geoPoint lat: 47.53333, lon: 21.63333, locations facility: Borbánya Praxis E.Ü. Kft., status: NOT_YET_RECRUITING, city: Nyíregyháza, state: Szabolcs-Szatmar Varmegye, zip: 4405, country: Hungary, geoPoint lat: 47.95539, lon: 21.71671, locations facility: Azienda Ospedaliera Papa Giovanni XXIII, status: NOT_YET_RECRUITING, city: Bergamo, zip: 24127, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Policlinico Mater Domini Università di Catanzaro, status: NOT_YET_RECRUITING, city: Catanzaro, zip: 88100, country: Italy, geoPoint lat: 38.88247, lon: 16.60086, locations facility: IRCCS Ospedale San Raffaele Milano, status: NOT_YET_RECRUITING, city: Milano, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Azienda Ospealiero Universitaria Policlinico Umberto I, status: NOT_YET_RECRUITING, city: Roma, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Centrum Medyczne Medyk Sp. z o.o., status: NOT_YET_RECRUITING, city: Rzeszow, state: Podkarpackie, zip: 35-055, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: Renew Clinic Bialystok, status: NOT_YET_RECRUITING, city: Białystok, zip: 15-794, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Centrum Terapii Wspolczesnej, status: NOT_YET_RECRUITING, city: Lodz, zip: 90-338, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: NBR Polska Tomasz Klodawski, status: NOT_YET_RECRUITING, city: Warszawa, zip: 00-710, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: King Abdulaziz Hospital-Al Ahsa-National Guard, status: NOT_YET_RECRUITING, city: Al Ahsa, zip: 36428, country: Saudi Arabia, locations facility: National Guard Hospital - Jeddah, status: NOT_YET_RECRUITING, city: Jeddah, zip: 21423, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, locations facility: King Fahad Medical City, status: NOT_YET_RECRUITING, city: Riyadh, zip: 11525, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: King Khaled University Hospital,King Saud Univ. Med. City, status: NOT_YET_RECRUITING, city: Riyadh, zip: 12372, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: King Salman Bin Abdulaziz Hospital, status: NOT_YET_RECRUITING, city: Riyadh, zip: 12769, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: CHC Zvezdara, Clinical department for endocrinology, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Clinical Hospital Center Bezanijska Kosa, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11080, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Clinical Hospital Centre Zemun, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11080, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False