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Clinical Trial Details

Trial ID: L4510
Source ID: NCT05394519
Associated Drug: Cagrilintide
Title: A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Acronym: REDEFINE 2
Status: COMPLETED
Study Results: NO
Results:
Conditions: Overweight|Obesity|Type 2 Diabetes Mellitus
Interventions: DRUG: Cagrilintide|DRUG: Semaglutide|DRUG: Placebo cagrilintide|DRUG: Placebo semaglutide
Outcome Measures: Primary: Relative change in body weight, Measured in percentage (%)., From baseline (week 0) to end of treatment (week 68)|Achievement of greater than or equal to (≥) 5% weight reduction, Count of participant., From baseline (week 0) to end of treatment (week 68) | Secondary: Achievement of ≥ 20% weight reduction, Count of participant., From baseline (week 0) to end of treatment (week 68)|Relative change in body weight, Measured in %., From baseline (week 0) to week 20|Change in waist circumference, Measured in centimeter (cm)., From baseline (week 0) to end of treatment (week 68)|Change in Glycated Haemoglobin (HbA1c), Measured in %-points., From baseline (week 0) to end of treatment (week 68)|Change in Systolic Blood Pressure (SBP), Measured in millimeter of mercury (mmHg)., From baseline (week 0) to end of treatment (week 68)|Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score, Measured in score points., From baseline (week 0) to end of treatment (week 68)|Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score, Measured in score points., From baseline (week 0) to end of treatment (week 68)|Change in body weight, Measured in kilogram (kg)., From baseline (week 0) to end of treatment (week 68)|Change in body mass index (BMI), Measured in kilogram per meter square (kg/m\^2)., From baseline (week 0) to end of treatment (week 68)|Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40), Count of participant., From baseline (week 0) to end of treatment (week 68)|Achievement of HbA1c less than or equal to (≤) 6.5%, Count of participant., At end of treatment (week 68)|Change in Fasting Plasma Glucose (mmol/L), Measured in millimoles per liter (mmol/L)., From baseline (week 0) to end of treatment (week 68)|Change in Fasting Plasma Glucose (mg/dL), Measured in milligram per deciliter (mg/dL), From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in fasting serum insulin, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Change in Diastolic Blood Pressure (DBP), Measured in mmHg., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in C-reactive protein (CRP), Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score, IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning., From baseline (week 0) to end of treatment (week 68)|Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score, CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control., From baseline (week 0) to end of treatment (week 68)|Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score, Count of participant., From baseline (week 0) to end of treatment (week 68)|Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score, Count of participant., From baseline (week 0) to end of treatment (week 68)|Change in IWQOL-Lite-CT Physical Function score, From baseline (week 0) to end of treatment (week 68)|Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup, Count of participant., From baseline (week 0) to end of treatment (week 68)|Continuous glucose monitoring: Change in mean glucose (mmol/L), Measured in mmol/L., From baseline (week 0) to end of treatment (week 68)|Continuous glucose monitoring: Change in mean glucose (mg/L), Measured in mg/L., From baseline (week 0) to end of treatment (week 68)|CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL), Measured in %-points., From baseline (week 0) to end of treatment (week 68)|CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL), Measured in %-points., From baseline (week 0) to end of treatment (week 68)|CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL), Measured in %-points., From baseline (week 0) to end of treatment (week 68)|CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL), Measured in %-points., From baseline (week 0) to end of treatment (week 68)|CGM: Within-day glycaemic variability (% CV), Measured in %., At end of treatment (week 68)|Number of Treatment Emergent Adverse Events (TEAEs), Count of events., From baseline (week 0) to end of study (week 75)|Number of Treatment Emergent Serious adverse events (TESAEs), Count of events., From baseline (week 0) to end of study (week 75)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), Count of episodes., From baseline (week 0) to end of study (week 75)|Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold, Count of episodes., From baseline (week 0) to end of study (week 75)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-01
Completion Date: 2025-02-03
Results First Posted:
Last Update Posted: 2025-03-13
Locations: John Muir Physicians Network, Concord, California, 94520, United States|Headlands Research California, LLC, Escondido, California, 92025, United States|St. Jos Heritage Hlthcr_Fllrtn, Fullerton, California, 92835, United States|Diabetes/Lipid Mgmt & Res Ctr, Huntington Beach, California, 92648, United States|Clinical Trials Research, Lincoln, California, 95648, United States|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|New West Physicians,Inc., Golden, Colorado, 80401, United States|Clinical Res Of W Florida Inc, Clearwater, Florida, 33765, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Jacksonville Ctr For Clin Res, Jacksonville, Florida, 32216, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|AdventHealth Diab Inst, Orlando, Florida, 32804, United States|Florida Institute for Clinical Research, LLC, Orlando, Florida, 32825, United States|Oviedo Medical Research, LLC, Oviedo, Florida, 32765, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|East West Med Res Inst, Honolulu, Hawaii, 96814, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50266, United States|Cotton-Oneill Diabetes and End, Topeka, Kansas, 66606-2806, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Pennington Biom Res Ctr, Baton Rouge, Louisiana, 70808, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|StudyMetrix Research LLC, Saint Peters, Missouri, 63303, United States|Mercury Str Med Grp, PLLC, Butte, Montana, 59701, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Great Lakes Medical Research, Westfield, New York, 14787, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Hillcrest Clinical Research, Simpsonville, South Carolina, 29681-1538, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Texas Diab & Endo, P.A., Austin, Texas, 78731, United States|Texas Diab & Endo, P.A., Austin, Texas, 78749, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|DCOL Ctr for Clin Res, Longview, Texas, 75605, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|National Clin Res Inc., Richmond, Virginia, 23294, United States|Selma Medical Associates, Winchester, Virginia, 22601-3834, United States|Amherst Family Practice P.C., Winchester, Virginia, 22601, United States|Capital Clin Res Ctr,LLC, Olympia, Washington, 98502, United States|Universitätsklinik für Innere Medizin Graz, Graz, 8036, Austria|Fließer-Görzer [Ordination], Saint Stefan, 8511, Austria|Klinik Landstraße, Wien, 1030, Austria|Universitätsklinikum AKH Wien, Wien, 1090, Austria|Imed 19- privat, Wien, 1190, Austria|LMC Clin Res Inc. Calgary, Calgary, Alberta, T2H 2G4, Canada|C-endo Diab Endo Clin Calgery, Calgary, Alberta, T2V 4J2, Canada|Dr. M.B. Jones Inc, Victoria, British Columbia, V8V 4A1, Canada|Commonwealth Medical Clinic, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Dr. Harpreet Bajaj, Brampton, Ontario, L6S 0C6, Canada|Centricity Research Etobicoke, Etobicoke, Ontario, M9R 4E1, Canada|Wharton Med Clin Trials, Hamilton, Ontario, L8L 5G8, Canada|LMC Research Inc. Ottawa, Nepean, Ontario, K2J 0V2, Canada|Diabetes Heart Research Centre, Toronto, Ontario, M6G 1M2, Canada|Centre Medical Acadie, Montreal, Quebec, H4N 2W2, Canada|Centricity Res Pointe-Claire, Pointe-Claire, Quebec, H9R 4S3, Canada|LMC Clin Rsrch Inc. (Montreal), Saint-Laurent, Quebec, H4T 1Z9, Canada|Diabetespraxis Mergentheim, Bad Mergentheim, 97980, Germany|Zentrum fuer klinische Studien Suedbrandenburg GmbH, Elsterwerda, 04910, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|AmBeNet GmbH, Leipzig, 04107, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|Erlinger, Stuttgart, 70378, Germany|Zentrum für klinische Studien Allgäu Oberschwaben, Wangen, 88239, Germany|Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ, Szeged, Csongrád-Csanád, 6725, Hungary|Debreceni Egyetem Belgyógyászati Klinika, Debrecen, Hajdu-Bihar, 4032, Hungary|Hetényi Géza Kórház, Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary|Selye János Kórház és Rendelőintézet, Komárom, Komárom-Esztergom, 2900, Hungary|Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1033, Hungary|Szőcs Depot Egészségügyi Szolgáltató Kft., Budapest, 1042, Hungary|Bajcsy-Zsilinszky Kórház, Budapest, 1106, Hungary|Selye János Kórház és Rendelőintézet, Komárom, 2900, Hungary|Hetényi Géza Kórház, Szolnok, 5004, Hungary|HCG Hospitals, Ahmedabad, Gujarat, 380006, India|Ramaiah Memorial Hospital, Bangalore, Karnataka, 560054, India|Calicut Medical College, Kozhikode, Kerala, 673008, India|Indian Institute of Diabetes, Thiruvananthapuram, Kerala, 695031, India|Excel Endocrine Centre, Kolhapur, Maharashtra, 416008, India|BYL Nair Hospital and T N Medical College Department of endo, Mumbai, Maharashtra, 400008, India|Seth GS medical college and KEM Hospital, Mumbai, Maharashtra, 400012, India|Sunil's Diabetes Care n' Research Centre Pvt Ltd, Nagpur, Maharashtra, 440010, India|Noble Hospitals Pvt Ltd., Pune, Maharashtra, 411013, India|All India Institute of Medical Sciences_Delhi, Ansari Nagar, New Delhi, 110029, India|Post Graduate Institute of Medical Education & Research_Chandigarh, Chandigarh, Punjab, 160012, India|J K Lon Hospital, SMS Medical College & Attached Hospitals, Jaipur, Rajasthan, 302004, India|SMS Medical College & Hospital, Jaipur, Rajasthan, 302004, India|Apollo Research & Innovation (ARI), Chennai, Tamil Nadu, 600006, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Gleneagles Hospitals, Hyderabad, Telangana, 500004, India|Apollo Multispeciality Hospital, Kolkata, Kolkata, West Bengal, 700054, India|Apollo Multispeciality Hospitals Limited, Kolkata, West Bengal, 700054, India|Sunil's Diabetes Care n' Research Centre Pvt Ltd, Nagpur, 440010, India|Lady Hardinge Medical College, New Delhi, 110001, India|CRF - Galway, Galway, Connaght, H91 YR71, Ireland|Clinical Research Centre, St. Vincent's University Hospital,, Dublin, Leinster, D04 T6F4, Ireland|Mater Miscericordiae Hospital, Dublin, Leinster, D07 XAO9, Ireland|St James's CRF, Dublin, Leinster, D08 A978, Ireland|Connolly Hospital, Dublin, Leinster, DUBLIN 15, Ireland|Mater Miscericordiae Hospital, Dublin, Leinster, DUBLIN 7, Ireland|TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi, 468-0009, Japan|Tokuyama clinic, Chiba, 261-0004, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Osaka Nishiumeda Clinic_Diabetes Internal Medicine, Osaka, 530-0001, Japan|Osaka University Hospital, Osaka, 565-0871, Japan|Takatsuki Red Cross Hospital, Osaka, 569-1045, Japan|Hospital Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia|Hospital Miri, Sarawak, Miri, 98000, Malaysia|Hospital Seri Manjung, Seri Manjung, Perak, 32040, Malaysia|Sarawak General Hospital, Kuching, Sarawak, 93586, Malaysia|Hospital Ampang, Ampang, Selangor, Selangor, 68000, Malaysia|University Technology MARA (UiTM) - Sg Buloh, Sungai Buloh, Selangor, 47000, Malaysia|Hospital Melaka, Melaka, 75400, Malaysia|Hospital Tuanku Jaafar, Seremban, 70300, Malaysia|Hospital Putrajaya, Wilayah Persekutuan Putrajaya, 62250, Malaysia|Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j., Legnica, Dolnośląskie, 59-220, Poland|Gierach-Med, Bygdoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland|Terpa Sp. z o.o. Sp. k., Lublin, Lubelskie Voivodeship, 20-333, Poland|Instytut Diabetologii Sp. z o.o., Warszawa, Mazovian Voivodeship, 02-117, Poland|Instytut Diabetologii Sp. z o.o., Warszawa, Mazovian, 02-117, Poland|Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego, Warszawa, Mazowieckie, 00-416, Poland|Medical Concierge Centrum Medyczne, Warszawa, Mazowieckie, 02-798, Poland|Linden sp. z o.o. sp. k., Kraków, Małopolskie, 30-721, Poland|Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, Podlaskie Voivodeship, 15-276, Poland|Gabinet Leczenia Otylosci i Chorob Dietozaleznych, Bialystok, Podlaskie Voivodeship, 15-281, Poland|Gabinet Leczenia Otylosci i Chorob Dietozaleznych, Bialystok, Podlaskie, 15-281, Poland|Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, 80-214, Poland|Centrum Medyczne Salvia, Katowice, Slaskie Voivodeship, 40-772, Poland|Klinika Bellamed, Elblag, Warmińsko-Mazurskie, 82-300, Poland|Centrum Zdrowia Metabolicznego, Poznan, Wielkopolskie Voivodeship, 60-589, Poland|Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, 15-276, Poland|Gierach-Med, Bygdoszcz, 85-796, Poland|Uniwersyteckie Centrum Kliniczne, Gdansk, 80-952, Poland|Linden sp. z o.o. sp. k., Kraków, 30-721, Poland|Terpa Sp. z o.o. Sp. k., Lublin, 20-333, Poland|Trialmed CRS, Piotrków Trybunalski, Łódzkie, 97-300, Poland|Ponce Med School Found Inc, Ponce, 00716, Puerto Rico|Siriraj Hospital_Bangkoknoi, Bangkok, Bangkoknoi, Bangkok, Bangkok, 10700, Thailand|Srinagarind Hospital, Muang, Khon Kaen, 40002, Thailand|Thammasat University Hospital, Klong Luang, Pathumthani, Pathumthani, 12120, Thailand|Ramathibodi Hospital, Bangkok, Ratchathewi Bangkok, 10400, Thailand|King Chulalongkorn Memorial Hospital_Bangkok, Bangkok, 10330, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Ramathibodi Hospital, Bangkok, 10400, Thailand|Harrogate District Hospital, Harrogate, North Yorkshire, HG2 7SX, United Kingdom|Crouch Oak Family Practice, Addlestone, Surrey, KT15 2BH, United Kingdom|Antrim Area Hospital, Antrim, BT42 2RL, United Kingdom|Layton Medical Centre, Blackpool, FY3 7EN, United Kingdom|The Health Centre, Bradford-on-Avon, BA15 1DQ, United Kingdom|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Hathaway Medical Centre, Chippenham, SN14 6GT, United Kingdom|HMC Health Heston, Hounslow, TW5 9ER, United Kingdom|Leicester General Hospital, Leicester, LE5 4PW, United Kingdom|Kiltearn Medical Centre, Nantwich, CW5 5NX, United Kingdom|Clifton Medical Centre, Rotherham, S65 1DA, United Kingdom|Ashfields Primary Care Centre, Sandbach, CW11 1EQ, United Kingdom|The Staploe Medical Centre, Soham, CB7 5JD, United Kingdom|Joint Clinical Research Facility - Swansea, Swansea, SA2 8PP, United Kingdom|Musgrove Park Hospital, Taunton, TA1 5DA, United Kingdom|Royal Cornwall Hospital (Treliske), Truro, TR1 3LJ, United Kingdom|Albany House Medical Centre, Wellingborough, NN8 4RW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05394519

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress