nctId: NCT06323174 id: NN9388-4895 id: 2022-502677-42 type: OTHER domain: European Medical Agency (EMA) 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 overallStatus: RECRUITING date: 2024-03-19 date: 2025-08-12 date: 2025-11-04 date: 2024-03-21 date: 2024-04-03 name: Novo Nordisk A/S class: INDUSTRY 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. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Placebo measure: Change in glycated haemoglobin (HbA1c) measure: Relative change in body weight measure: Number of participants who achieve greater than or equal to (>=) 10% body weight reduction measure: Number of participants who achieve >=15% body weight reduction measure: Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) measure: Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol) measure: Change in Fasting Plasma Glucose (FPG) measure: Number of participants who achieve >=5% body weight reduction measure: Number of participants who achieve >=20% body weight reduction measure: Change in waist circumference measure: Change in systolic blood pressure (SBP) measure: Change in diastolic blood pressure (DBP) measure: Ratio to baseline in high sensitivity C-reactive protein (hsCRP) measure: Ratio to baseline in lipids: Total cholesterol measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol measure: Ratio to baseline in lipids: Triglycerides measure: Ratio to baseline in lipids: Free fatty acids measure: Ratio to baseline in lipids: Non-HDL cholesterol measure: Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication) measure: Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo) measure: Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score measure: Change in SF-36v2 score: Physical Component Summary score measure: Change in SF-36v2 score: Mental Component Summary score measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score measure: Change in leptin measure: Change in soluble leptin receptor measure: Number of Treatment Emergent Adverse Events (TEAEs) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Research Institute_Huntington Park status: RECRUITING city: Huntington Park state: California zip: 90255 country: United States lat: 33.98168 lon: -118.22507 facility: Valley Clinical Trials, Inc. status: RECRUITING city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Southern California Dermatology status: RECRUITING city: Santa Ana state: California zip: 92701 country: United States lat: 33.74557 lon: -117.86783 facility: Encore Medical Research LLC status: RECRUITING city: Hollywood state: Florida zip: 33021 country: United States lat: 26.0112 lon: -80.14949 facility: Alliance for Multispec Res status: NOT_YET_RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Brigham & Women's Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Arcturus Healthcare, PLC status: RECRUITING city: Troy state: Michigan zip: 48098 country: United States lat: 42.60559 lon: -83.14993 facility: Holston Medical Group status: RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Northeast Clinical Research of San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78233 country: United States lat: 29.42412 lon: -98.49363 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Consano Clinical Research, LLC status: NOT_YET_RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Chinese People's Liberation Army General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University_Zhenjiang status: NOT_YET_RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Ji'Nan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 facility: Belinus Bt. status: NOT_YET_RECRUITING city: Debrecen state: Hajdu-Bihar Varmegye zip: 4025 country: Hungary lat: 47.53333 lon: 21.63333 facility: Borbánya Praxis E.Ü. Kft. status: NOT_YET_RECRUITING city: Nyíregyháza state: Szabolcs-Szatmar Varmegye zip: 4405 country: Hungary lat: 47.95539 lon: 21.71671 facility: Azienda Ospedaliera Papa Giovanni XXIII status: NOT_YET_RECRUITING city: Bergamo zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 facility: Policlinico Mater Domini Università di Catanzaro status: NOT_YET_RECRUITING city: Catanzaro zip: 88100 country: Italy lat: 38.88247 lon: 16.60086 facility: IRCCS Ospedale San Raffaele Milano status: NOT_YET_RECRUITING city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 facility: Azienda Ospealiero Universitaria Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Centrum Medyczne Medyk Sp. z o.o. status: NOT_YET_RECRUITING city: Rzeszow state: Podkarpackie zip: 35-055 country: Poland lat: 50.04132 lon: 21.99901 facility: Renew Clinic Bialystok status: NOT_YET_RECRUITING city: Białystok zip: 15-794 country: Poland lat: 53.13333 lon: 23.16433 facility: Centrum Terapii Wspolczesnej status: NOT_YET_RECRUITING city: Lodz zip: 90-338 country: Poland lat: 51.75 lon: 19.46667 facility: NBR Polska Tomasz Klodawski status: NOT_YET_RECRUITING city: Warszawa zip: 00-710 country: Poland lat: 52.22977 lon: 21.01178 facility: King Abdulaziz Hospital-Al Ahsa-National Guard status: NOT_YET_RECRUITING city: Al Ahsa zip: 36428 country: Saudi Arabia facility: National Guard Hospital - Jeddah status: NOT_YET_RECRUITING city: Jeddah zip: 21423 country: Saudi Arabia lat: 21.54238 lon: 39.19797 facility: King Fahad Medical City status: NOT_YET_RECRUITING city: Riyadh zip: 11525 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: King Khaled University Hospital,King Saud Univ. Med. City status: NOT_YET_RECRUITING city: Riyadh zip: 12372 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: King Salman Bin Abdulaziz Hospital status: NOT_YET_RECRUITING city: Riyadh zip: 12769 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: CHC Zvezdara, Clinical department for endocrinology status: NOT_YET_RECRUITING city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: Clinical Hospital Center Bezanijska Kosa status: NOT_YET_RECRUITING city: Belgrade zip: 11080 country: Serbia lat: 44.80401 lon: 20.46513 facility: Clinical Hospital Centre Zemun status: NOT_YET_RECRUITING city: Belgrade zip: 11080 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False