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Clinical Trial Details

Trial ID: L3676
Source ID: NCT06221969
Associated Drug: Cagrilintide
Title: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Cagrilintide|DRUG: Semaglutide|DRUG: Tirzepatide
Outcome Measures: Primary: Change in glycated haemoglobin (HbA1c), Measured in percentage (%)-points., From baseline (week 0) to end of treatment (week 68)|Relative change in body weight, Measured in percentage (%)., From baseline (week 0) to end of treatment (week 68) | Secondary: Change in HbA1c, Measured in %-points., From baseline (week 0) to end of treatment (week 68)|Change in fasting plasma glucose (FPG), Measured in millimoles per liter (mmol/L)., From baseline (week 0) to end of treatment (week 68)|Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol]), Count of participant, At end of treatment (week 68)|Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol), Count of participant, 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)|Achievement of ≥ 10% weight reduction, Count of participant, From baseline (week 0) to end of treatment (week 68)|Achievement of ≥ 15 % weight reduction, Count of participant, From baseline (week 0) to end of treatment (week 68)|Achievement of ≥ 20 % weight reduction, Count of participant, From baseline (week 0) to end of treatment (week 68)|Change in systolic blood pressure, Measured in millimeters of mercury(mmHg)., From baseline (week 0) to end of treatment (week 68)|Change in diastolic blood pressure, Measured in mmHg., From baseline (week 0) to end of treatment (week 68)|Change in waist circumference, Measured in centimeter (cm)., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: Total cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: Triglycerides, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Ratio to baseline in lipids: non-HDL cholesterol, Measured in ratio., From baseline (week 0) to end of treatment (week 68)|Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey, The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale., From baseline (week 0) to end of treatment (week 68)|Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3, 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. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning., From baseline (week 0) to end of treatment (week 68)|Number of Treatment-emergent Adverse Events (TEAEs), Count of events, From baseline (week 0) to end of study (week 74)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter), Count of episodes, From baseline (week 0) to end of study (week 74)|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 74)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1000
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-16
Completion Date: 2026-04-03
Results First Posted:
Last Update Posted: 2025-04-08
Locations: Univ of Alabama_Birmingham, Birmingham, Alabama, 35233, United States|Prime Medical Group, LLC, Gilbert, Arizona, 85296, United States|Velocity Clinical Research-Phoenix, Phoenix, Arizona, 85006, United States|Synexus Rsch /Cnt Phnx Med C, Phoenix, Arizona, 85020, United States|Arkansas Clinical Research, Little Rock, Arkansas, 72205, United States|Unity Health-Searcy Medical Center, Searcy, Arkansas, 72143, United States|Velocity Clin Res-Chula Vista, Chula Vista, California, 91911, United States|Headlands Research California, LLC, Escondido, California, 92025, United States|Neighborhood Healthcare, Escondido, California, 92025, United States|St. Jude Heritage Yorba Linda - Pediatric Ste D, Fullerton, California, 92835, United States|Diabetes & Endocrine Specialists - La Mesa, La Mesa, California, 91942, United States|Diabetes and Endocrine Specialists - La Mesa, La Mesa, California, 91942, United States|Velocity Clin Res San Diego, La Mesa, California, 91942, United States|Clinical Trials Research, Lincoln, California, 95648, United States|Loma Linda Univ Hlth Cr Endo, Loma Linda, California, 92354, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Desert Oasis Healthcare, Palm Springs, California, 92262, United States|Velocity Clin Res - Panorama, Panorama City, California, 91402, United States|Western University of Health Sciences, Pomona, California, 91766, United States|Endocrinology Josel Cabaccan, San Jose, California, 95148, United States|Mills-Peninsula Medical Center, San Mateo, California, 94401, United States|NorCal Endocrinology and Internal Medicine, San Ramon, California, 94583, United States|Premier Medical Center, Inc., Toluca Lake, California, 91602, United States|Velocity Clin Res - Panorama, Van Nuys, California, 91405, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|University of Colorado Hospital, Aurora, Colorado, 80045, United States|Optumcare Colorado Springs, Colorado Springs, Colorado, 80906, United States|Northeast Res Inst. Inc., Jacksonville, Florida, 32204, 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|Oviedo Medical Research, LLC, Oviedo, Florida, 32765, United States|Hope Clin Res & Wellness, Conyers, Georgia, 30094, United States|Center for Adv Res & Education, Gainesville, Georgia, 30501, United States|Urban Family Practice Assoc, Marietta, Georgia, 30067, United States|Endocrine Research Solutions, Roswell, Georgia, 30076, United States|St. Luke's Health System, Boise, Idaho, 83702, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Clinical Invest Special_Gurnee, Gurnee, Illinois, 60031, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Evanston Premier Hlthcr Res, Skokie, Illinois, 60077, United States|Iowa Diabetes & Endo Res Ctr, West Des Moines, Iowa, 50266, United States|Cotton-O'Neil Diab & Endo Ctr, Topeka, Kansas, 66606, United States|MedStar Hlth Res Institute, Hyattsville, Maryland, 20782, United States|Joslin Center For Diabetes, Boston, Massachusetts, 02215, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Belzoni Clinical Research, Belzoni, Mississippi, 39038, United States|Velocity Clin Res Gulfport, Gulfport, Mississippi, 39503, United States|Diabetes & Endo Specialists Inc, Chesterfield, Missouri, 63017, United States|Amicis Centers of Clinical Research, Saint Louis, Missouri, 63128, United States|StudyMetrix Research LLC, Saint Peters, Missouri, 63303, United States|Velocity Clin Res Albuquerque, Albuquerque, New Mexico, 87107, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Velocity Clin Res Syracuse, East Syracuse, New York, 13057, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|UNC Eastowne Clinical Research Unit, Chapel Hill, North Carolina, 27514, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Lucas Research Inc., Morehead City, North Carolina, 28557, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Plains Clinical Research Center, LLC, Fargo, North Dakota, 58104, United States|Remington Davis Inc, Columbus, Ohio, 43215, United States|Advanced Medical Research, Maumee, Ohio, 43537, United States|New Venture Medical Research, Wadsworth, Ohio, 44281-9236, United States|Lynn Institute of Norman, Norman, Oklahoma, 73072, United States|CCT Research, Horsham, Pennsylvania, 19044, United States|Thomas Jefferson University_Philadelphia, Philadelphia, Pennsylvania, 19114, United States|Clinical Res Collaborative, Cumberland, Rhode Island, 02864, United States|Velocity Clinical Res-Anderson, Anderson, South Carolina, 29621, United States|Trial Management Associates, Myrtle Beach, South Carolina, 29572, United States|Hillcrest Clinical Research, Simpsonville, South Carolina, 29681-1538, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Holston Medical Group Pc, Bristol, Tennessee, 37620-7352, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|Jackson Clinic, Jackson, Tennessee, 38305, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Clinical Neuroscience Solutions, Memphis, Tennessee, 38119, United States|HealthStar Physicians PC, Morristown, Tennessee, 37813, United States|Clinical Research Associates, Nashville, Tennessee, 37203, United States|Arlington Family Res. Ctr Inc, Arlington, Texas, 76012-4637, United States|Velocity Clin Res, Austin, Texas, 78759, United States|UT Health University of Texas, Bellaire, Texas, 77401, United States|Velocity Clin Res, Dallas, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Synexus Clin Res Dallas, Dallas, Texas, 75234, United States|Cedar Health Research, Dallas, Texas, 75251, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Juno Research, LLC_Houston, Houston, Texas, 77040, United States|Discovery MM Services, Inc, Houston, Texas, 77061, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Amir Ali Hassan, MD, PA, Houston, Texas, 77089, United States|Fmc Science, Llc, Lampasas, Texas, 76550, United States|Quality Clinical Research, Inc., San Antonio, Texas, 78209, United States|University of Texas San Antonio, San Antonio, Texas, 78229, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Mt Olympus Medical Research, LLC, Sugar Land, Texas, 77478, United States|DM Clin Rsrch/Fam Diag Clinic, Tomball, Texas, 77375, United States|Foothill Family Clinic South, Salt Lake City, Utah, 84121, United States|J.Lewis Research Inc, South Jordan, Utah, 84095, United States|Velocity Clin Res-Salt Lk City, West Jordan, Utah, 84088, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Rainier Clin Res Ctr Inc, Renton, Washington, 98057, United States|Prevea Health, Green Bay, Wisconsin, 54303, United States|Buenos Aires Mácula, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAE, Argentina|Instituto Medico Especializado_Capital Federal, Ciudad de Buenos Aires, Buenos Aires, C1405CWB, Argentina|Instituto de Investigaciones Metabolicas (IDIM), Buenos Aires, C1012AAR, Argentina|Centro de Investigación Clínica, Caba, C1060ABA, Argentina|OMI- Organización Médica de Investigación, Ciudad Autonoma de Buenos Aires, C1015, Argentina|CICEMO- Consultorio de Investigación Clínica EMO, Ciudad Autonoma de Buenos Aires, C1405BUB, Argentina|Instituto de Investigaciones Clinicas, Mar del Plata, B7600FZN, Argentina|CEDIR - Centro de diagnóstico y rehabilitación Santa Fe, Santa Fe, S3000FSO, Argentina|Paratus Clinical, Blacktown, New South Wales, 2148, Australia|Paratus Clinical, Kanwal, New South Wales, 2259, Australia|Hunter Diabetes Centre, Merewether, New South Wales, 2291, Australia|Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Townsville University Hospital, Douglas, Queensland, 4814, Australia|University of Sunshine Coast, Morayfield, Queensland, 4506, Australia|Momentum Clinical Research, Taringa, Queensland, 4068, Australia|Southern Adelaide Diabetes & Endocrine Services, Oaklands Park, South Australia, 5046, Australia|The Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Austrials, St Albans, Victoria, 3021, Australia|Momentum Clinical Research, St Albans, Victoria, 3021, Australia|TLC Diabetes and Endocrinology, Surrey, British Columbia, V3T 2V6, Canada|Ocean West Research Clinic, Surrey, British Columbia, V3Z 2N6, Canada|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|Milestone Research, London, Ontario, N5W 6A2, Canada|Western Univ. Cnt for Studies in Fam Med, London, Ontario, N6G 2M1, Canada|London Road Diagnostic Clinic and Medical Centre, Sarnia, Ontario, N7T 4X3, Canada|Diabetes Heart Research Centre, Toronto, Ontario, M6G 1M2, 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|Clin des Mal Lipid de Quebec, Quebec, G1V 4W2, Canada|Centre de Recherche Saint-Louis, Quebec, G1W 4R4, Canada|Clinica de la Costa, Barranquilla, Atlántico, 80020, Colombia|Cimedical, Barranquilla, 80001, Colombia|Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S., Bogotá, 110221, Colombia|UNIENDO, Bogotá, 110221, Colombia|Nirmal Hospital Pvt. Ltd., Surat, Gujarat, 395002, India|SSG Hospital, Baroda, Vadodara, Gujarat, 390001, India|Belgaum Diabetes Centre, Belgaum, Karnataka, 590001, India|Government Medical College, Kozhikode, Kozhikode, Kerala, 673008, India|Indian Institute of Diabetes, Thiruvnanthapuram, Kerela, 695033, India|Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India|BSES MG hospital, Mumbai, Maharashtra, 400058, India|Grant Medical Foundation Ruby Hall Clinic, Pune, Maharashtra, 411001, India|Chellaram Diabetes Institute, Pune, Maharashtra, 411021, India|Maulana Azad Medical College, Delhi, New Delhi, 110002, India|SMS Medical College & Hospital, Jaipur, Rajasthan, 302004, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Christian Medical College Hospital, Vellore, Vellore, Tamil Nadu, 632004, India|AIG Hospitals,Hyderabad, Hyderabad, Telangana, 500032, India|Government Institute of Medical Sciences, Noida, Uttar Pradesh, 201310, India|BP Poddar Hospital, Kolkata,, West Bengal, 700053, India|Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University, Aligarh, 202002, India|SRM Centre for Clinical Trials & Research, Chennai, 603203, India|Nirmal Hospital Pvt. Ltd., Surat, 395002, India|Jothydev's Diabetes & Research Center, Thriruvananthapuram, 695 032, India|Dr Wilhase's rooms, Boksburg, Gauteng, 1466, South Africa|Ubuntu Clinical Research, Johannesburg, Gauteng, 1827, South Africa|Krugersdorp Medical Centre, Krugersdorp, Gauteng, 1739, South Africa|Synapta Clinical Research Centre, Durban, KwaZulu-Natal, 4001, South Africa|Dr J Reddy, Durban, KwaZulu-Natal, 4450, South Africa|Bella Vita Clinical Research, Cape Town, Western Cape, 7560, South Africa|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, 807, Taiwan|Chung Shan Medical University Hospital, Taichung City, 402, Taiwan|Taichung Veterans General Hospital, Taichung City, 407, Taiwan|Kuang Tien General Hospital, Taichung City, 433, Taiwan|National Cheng Kung University Hospital, Tainan City, 704, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Taipei Veterans General Hospital, Taipei, 112, Taiwan
URL: https://clinicaltrials.gov/show/NCT06221969

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