A Research Study to See How Much CagriSema (1.0 mg Once Weekly) Lowers Blood Sugar and Body Weight Compared to Tirzepatide (5 mg Once Weekly) in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
NCT Number: NCT06534411
Acronym: REIMAGINE 5
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Cagrilintide|DRUG: Semaglutide|DRUG: Tirzepatide
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-05
Completion Date: 2026-08-18
Locations: Cahaba Research, Pelham, Alabama, 35124, United States|Velocity Clinical Research-Phoenix, Phoenix, Arizona, 85006, United States|AES Tucson DRS, Tucson, Arizona, 85712, United States|Woodland Int. Research Group, Little Rock, Arkansas, 72211, United States|Velocity Clin Res-Chula Vista, Chula Vista, California, 91911, United States|John Muir Physicians Network, Concord, California, 94520, United States|Diabetes & Endocrine Specialists - La Mesa, La Mesa, California, 91942, United States|Velocity Clin Research LA, Los Angeles, California, 90057, United States|Desert Oasis Healthcare, Palm Springs, California, 92262, United States|Velocity Clin Res - Panorama, Panorama City, California, 91402, United States|Velocity Clin Res Santa Ana, Santa Ana, California, 92704, United States|Optumcare Colorado Springs, Colorado Springs, Colorado, 80906, United States|FEME Medical LLC, Washington, District of Columbia, 20010, United States|Tampa Bay Medical Research, Clearwater, Florida, 33761, United States|AGA Clinical Trial, Hialeah, Florida, 33012, United States|Clinical Trial Services Corp, Miami, Florida, 33144, United States|Bioclinical Research Alliance, Miami, Florida, 33155, United States|New Horizon Research Center, Miami, Florida, 33165, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|West Orange Endocrinology, Ocoee, Florida, 34761, United States|Optimal Research Sites, Orange City, Florida, 32763, United States|Javara Inc. / Privia Medical Group Georgia LLC, Fayetteville, Georgia, 30214, United States|Clinical Invest Special_Gurnee, Gurnee, Illinois, 60031, United States|Iowa Diabetes & Endo Res Ctr, West Des Moines, Iowa, 50265, United States|Cotton-Oneill Diabetes and End, Topeka, Kansas, 66606-2806, United States|AES Minneapolis DRS, Richfield, Minnesota, 55423, United States|Velocity Clin Res Gulfport, Gulfport, Mississippi, 39503, United States|AES St. Louis DRS, Saint Louis, Missouri, 63141, United States|Univ of Nebraska Medical CTR, Omaha, Nebraska, 68198-3020, United States|Velocity Clin Res Albuquerque, Albuquerque, New Mexico, 87107, United States|Albany Medical College, Albany, New York, 12208, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Triad Research Institute, Norman, Oklahoma, 73072, United States|Circuit Clinical - PMSI, Pottstown, Pennsylvania, 19465, United States|Clinical Res Collaborative, Cumberland, Rhode Island, 02864, United States|Velocity Clin Res Providence, East Greenwich, Rhode Island, 02818, United States|Velocity Clin Res Gaffney, Gaffney, South Carolina, 29340, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Clinical Research Associates, Nashville, Tennessee, 37203, United States|Velocity Clin Res Austin, Austin, Texas, 78759, United States|AES Dallas DFW DRS, Dallas, Texas, 75234, United States|UT Southwestern Medical Center - Lingvay, Dallas, Texas, 75390, United States|Juno Research, LLC_Houston, Houston, Texas, 77040, United States|Discovery MM Services - Houston - Broadway Street, Houston, Texas, 77061, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Sante Clinical Research, Kerrville, Texas, 78028, United States|Aeres Clinical Research, Laredo, Texas, 78041, United States|RGV Endocrine Center, McAllen, Texas, 78503, United States|Privia Health Javara Clin Res., Stephenville, Texas, 76401, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|J.Lewis Research Inc, Salt Lake City, Utah, 84109, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Centro Médico CIMEL, Lanus Este, Buenos Aires, B1824KAJ, Argentina|Centro de Investigaciones Médicas Clínica de Fracturas y Or, Mar del Plata, Buenos Aires, B7600GNY, Argentina|Fundación CESIM, Santa Rosa, La Pampa, 6300, Argentina|Centro de Investigaciones Médicas Tucumán, San Miguel De Tucuimán, Tucumán, 4000, Argentina|IMOBA, City of Buenos Aires, C1056ABH, Argentina|Centro de Investigaciones Metabólicas, City of Buenos Aires, C1056ABI, Argentina|Instituto de Investigaciones Clinicas San Nicolás, San Nicolás, B2900, Argentina|Paratus Clinical, Bruce, Australian Capital Territory, 2617, Australia|Hunter Diabetes Centre, Merewether, New South Wales, 2291, Australia|Austrials, St Leonards, New South Wales, 2065, Australia|Western Endocrine Blacktown, Sydney, New South Wales, 2148, Australia|Townsville University Hospital, Douglas, Queensland, 4814, Australia|Paratus Clinical, Herston, Queensland, 4006, Australia|Centro de Diabetes Curitiba, Curitiba, Parana, 80810-040, Brazil|Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda., Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|Hilltop Medical Clinic, Surrey, British Columbia, V4A 0C1, Canada|G.A. Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|Centricity Research Brampton, Brampton, Ontario, L6S 0C6, Canada|Centricity Research Etobicoke, Etobicoke, Ontario, M9R 4E1, Canada|Wharton Med Clin Trials, Hamilton, Ontario, L8L 5G8, Canada|London Road Diagnostic Clinic and Medical Centre, Sarnia, Ontario, N7T 4X3, Canada|Diabetes Heart Research Centre, Toronto, Ontario, M6G 1M2, Canada|Ctr de rech Clin de Laval, Laval, Quebec, H7T 2P5, Canada|Alpha Recherche Clinique - Clinique de Levis, Levis, Quebec, G6V 6E2, Canada|Centre Medical Acadie, Montreal, Quebec, H4N 2W2, Canada|Ctr de Med Metab de Lanaudiere, Terrebonne, Quebec, J6X 4P7, Canada|Diex Recherche Victoriaville, Victoriaville, Quebec, G6P 3Z8, Canada|Centre de Recherche Saint-Louis, Quebec, G1W 4R4, Canada|Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Essen, 45147, Germany|Praxis am Markt Dr. Becker, Essen, 45355, Germany|Universitätsklinikum Freiburg, Freiburg, 79106, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Medicover Neuroendokrinologie MVZ, München, 81667, Germany|MedicalCenter am Clemenshospital, Münster, 48153, Germany|Zentrum für klinische Studien Allgäu Oberschwaben, Wangen, 88239, Germany|Alexandra General Hospital, Therapeutic Clinic, Athens, Attiki, GR-11528, Greece|Venizeleio Pananeio, Heraklion, Crete, 71409, Greece|Evangelismos Hospital, Athens, GR-10676, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, GR-17562, Greece|"Laiko" General Hospital of Athens, Goudi/Athens, 11527, Greece|University General Hospital of Ioannina,Internal Medicine, Ioannina, 45500, Greece|'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki, 54642, Greece|General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki, GR-54635, Greece|Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ, Szeged, Csongrád-Csanád, H-6725, Hungary|Selye János Kórház és Rendelőintézet, Komárom, Komárom-Esztergom, 2900, Hungary|QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft, Budapest, Pest, 1036, Hungary|Óbudai Egészségügyi Centrum, Budapest, 1036, Hungary|Szőcs Depot Egészségügyi Szolgáltató Kft., Budapest, 1042, Hungary|Semmelweis Egyetem, Budapest, 1083, Hungary|ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1089, Hungary|PVN Kutato Kft., Budapest, 1102, Hungary|MED-TIMA Kft., Budapest, 1132, Hungary|Észak-Pesti Centrumkórház Honvédkórház, Budapest, 1134, Hungary|Endolife Specialty Hospitals, Guntur, Andhra Pradesh, 522001, India|All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, India|Ramaiah Memorial Hospital, Bengaluru, Karnataka, 560054, India|Excel Endocrine Centre, Kolhapur, Maharashtra, 416008, India|Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha, Wardha, Maharashtra, 442001, India|Jawahar Lal Nehru Govt. Medical College, Ajmer, Rajasthan, 305001, India|SMS Hospital, Jaipur, Rajasthan, 302004, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Arthur Asirvatham hospital,, Madurai, Tamil Nadu, 625 020, India|AIG Hospitals,Hyderabad, Hyderabad, Telangana, 500032, India|Udyaan Health Care, Lucknow, Uttar Pradesh, 226002, India|IPGME&R and SSKM Hospital, Kolkata, West Bengal, 700020, India|Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India|Diabetes and obesity center of excellence, Rambam MC, Haifa, 31096, Israel|Clalit sick fund Herzlia, Herzlia, 4630945, Israel|Diabetes Clinic Wolfson MC, Holon, 58100, Israel|Diabetes Unit Hadassah Ein Karem MC, Jerusalem, 91120, Israel|Rabin MC Beilinson Campus Endo, Petah-Tikva, 49100, Israel|Endrocrinolgy Clinic - Sheba Medical Center, Tel Hashomer, 52621, Israel|Institute of Endocrinology, metabolism and hypertension, Tel-Aviv, 64239, Israel|Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, Podlaskie Voivodeship, 15-276, Poland|Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, 15-276, Poland|Diab Serwis Popenda Spółka Jawna, Chorzów, 41-516, Poland|Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław, Gorzow Wielkopolski, 66-400, Poland|Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland|Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A., Olsztyn, 10-117, Poland|Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA, Sosnowiec, 41-209, Poland|Centrum Medyczne Oporow, Wroclaw, 52-416, Poland|Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko, Zabrze, 41-800, Poland|Diabdana S.R.L., Oradea, Bihor, 410147, Romania|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|CMI Dr Pop Lavinia, Baia Mare, Maramures, 430222, Romania|Sc Mediab Srl, Tirgu Mures, Mures, 540142, Romania|SC Nutrilife SRL, Bucharest, 013764, Romania|Diabet Med SRL, Bucuresti, 050913, Romania|Sanamed Hospital SRL, Bucuresti, 060013, Romania|Clinica Korall S.R.L. Satu Mare, Satu-Mare, 440055, Romania|Clinica Universitaria de Navarra, Pamplona, Navarra, 31008, Spain|Centro Periferico De Especialidades Bola Azul, Almeria, 04009, Spain|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital Universitario San Cecilio, Granada, 18016, Spain|Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Hospital Clínico de Valladolid, Valladolid, 47003, Spain|Chang Gung Memorial Hospital - Kaoshiung Branch, Kaohsiung City, 833, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaoshiung, 807, Taiwan|China Medical University Hospital, Taichung City, 404328, Taiwan|Taichung Veterans General Hospital, Taichung City, 407, Taiwan|National Cheng Kung University Hospital, Tainan City, 704, Taiwan|Taipei Veterans General Hospital, Taipei, 112, Taiwan|Chang Gung Memorial Hospital Linkou, Taoyuan City, 333, Taiwan

Summary:
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Primary Outcome Measures: Change in Glycated Haemoglobin (HbA1c), Measured in percentage points., From baseline (week 0) to end of treatment (week 60)|Relative Change in Body Weight, Measured in percentage (%)., From baseline (week 0) to end of treatment (week 60)
Secondary Outcome Measures: Change in HbA1c, Measured in percentage points., From baseline (week 0) to end of treatment (week 60)|Change in Fasting Plasma Glucose (FPG), Measured as millimole per liter (mmol/L)., From baseline (week 0) to end of treatment (week 60)|Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol]), Measured as count of participants., At end of treatment (week 60)|Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol), Measured as count of participants., At end of treatment (week 60)|Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 60)|Number of Participants Who Achieve >= 10% Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 60)|Number of Participants Who Achieve >= 15% Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 60)|Number of Participants Who Achieve >= 20% Weight Reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 60)|Change in Systolic Blood Pressure (SBP), Measured in millimeter of mercury (mmHg)., From baseline (week 0) to end of treatment (week 60)|Change in Diastolic Blood Pressure (DBP), Measured in mmHg., From baseline (week 0) to end of treatment (week 60)|Change in Waist Circumference, Measured in centimeter (cm)., From baseline (week 0) to end of treatment (week 60)|Ratio to Baseline in Lipids: Total Cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 60)|Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 60)|Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 60)|Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 60)|Ratio to Baseline in Lipids: Triglycerides, Measured as ratio., From baseline (week 0) to end of treatment (week 60)|Ratio to Baseline in Lipids: Non-HDL cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 60)|Change in Short Form (SF) -36v2 Score: Physical Component Summary Score, Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being., From baseline (week 0) to end of treatment (week 60)|Change in SF-36v2 Score: Mental Component Summary Score, Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being., From baseline (week 0) to end of treatment (week 60)|Change in SF-36v2 Score: Vitality Subscale, Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being., From baseline (week 0) to end of treatment (week 60)|Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score, Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Physical functioning score ranges from 0 to 100, with higher scores reflecting better levels of functioning., From baseline (week 0) to end of treatment (week 60)|Change in IWQOL-Lite-CT: Total score, Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score ranges from 0 to 100, with higher scores reflecting better levels of functioning., From baseline (week 0) to end of treatment (week 60)|Number of Treatment Emergent Adverse Events (TEAEs), Measured as count of events., From baseline (week 0) to end of study (week 66)|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter, Measured as count of episodes., From baseline (week 0) to end of study (week 66)|Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold, Measured as count of episodes., From baseline (week 0) to end of study (week 66)