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Clinical Trial Details

Trial ID: L5874
Source ID: NCT06660173
Associated Drug: Maridebart Cafraglutide
Title: A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Maridebart Cafraglutide|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c), Baseline to Week 24 | Secondary: Percent Change From Baseline to Week 24 in Body Weight, Baseline to Week 24|Number of Participants Achieving HbA1c < 7.0% at Week 24, Week 24|Number of Participants Achieving HbA1c ≤ 6.5% at Week 24, Week 24|Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24, Week 24|Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24, Week 24|Change From Baseline to Week 24 in Fasting Glucose, Baseline to Week 24|Percent Change From Baseline to Week 24 in Total Cholesterol, Baseline to Week 24|Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C), Baseline to Week 24|Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C), Baseline to Week 24|Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C), Baseline to Week 24|Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C), Baseline to Week 24|Percent Change From Baseline to Week 24 in Triglycerides, Baseline to Week 24|Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA), Baseline and Week 24|Change From Baseline to Week 24 in Systolic Blood Pressure, Baseline and Week 24|Change From Baseline to Week 24 in Diastolic Blood Pressure, Baseline and Week 24|Change from Baseline to Week 24 in High-sensitivity C-reactive Protein, Baseline and Week 24|Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20, Week 20|Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20, Week 20|Number of Participants with Treatment Emergent Adverse Events, Up to 24 Weeks|Number of Participants with Serious Adverse Events, Up to 24 Weeks|Number of Participants with Anti-maridebart Cafraglutide Antibody Formation, Up to Week 24
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 350
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-07
Completion Date: 2026-07-22
Results First Posted:
Last Update Posted: 2025-03-26
Locations: Accel Research Site - Birmingham Clinical Research Unit, Birmingham, Alabama, 35216, United States|Anaheim Clinical Trials, Anaheim, California, 92801, United States|Hope Clinical Research LLC, Canoga Park, California, 91303, United States|Orange County Research Center, Lake Forest, California, 92630, United States|San Jose Clinical Trials, San Jose, California, 95128, United States|Northeast Research Institute - Neri, Fleming Island, Florida, 32003, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Florida Institute for Clinical Research, Orlando, Florida, 32825, United States|Conquest Research - Winter Park, Winter Park, Florida, 32789, United States|Accel Research Site - Neurostudies, Decatur, Georgia, 30030, United States|Cedar Crosse Research and Health Care, Chicago, Illinois, 60607, United States|Tandem Clinical Research - Marrero, Marrero, Louisiana, 70072, United States|DM Clinical - Detroit, Southfield, Michigan, 48076, United States|Montana Medical Research, Missoula, Montana, 59808, United States|Physicians East, Greenville, North Carolina, 27834, United States|Diabetes and Endocrinology Associates of Stark County Inc, Canton, Ohio, 44718, United States|Alliance for Multispecialty Research, Norman, Oklahoma, 73069, United States|Trial Management Associates - Myrtle Beach, Myrtle Beach, South Carolina, 29572, United States|FutureSearch Trials of Neurology, Austin, Texas, 78731, United States|Velocity Clinical Research - Dallas, Dallas, Texas, 75230, United States|DM Clinical Research - Cyfair Clinical Research Center, Houston, Texas, 77065, United States|Southern Endocrinology Associates PA, Mesquite, Texas, 75149, United States|Be Well Clinical Studies, Round Rock, Texas, 78681, United States|Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229, United States|DM Clinical Research - Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Charlottesville Medical Research Center, Charlottesville, Virginia, 22911, United States|Manassas Clinical Research Center Inc, Manassas, Virginia, 20110, United States|Eastside Research Associates Health Research, Redmond, Washington, 98052, United States|Medizinische Universitaet Graz, Graz, 8036, Austria|Krankenhaus der Barmherzigen Brueder Linz, Linz, 4021, Austria|Universitaetsklinikum Allgemeines Krankenhaus Wien, Wien, 1090, Austria|Klinik Hietzing, Wien, 1130, Austria|Laiko General Hospital of Athens, Athens, 11527, Greece|Athens Medical Center S.A - Iatriko Amarousiou, Maroussi, 15125, Greece|Athens Medical Center- Iatriko Paleou Falirou, Palaio Faliro, 17562, Greece|Geniko Nosokomeio Peiraia Tzaneio, Piraeus, 18536, Greece|General Hospital of Thessaloniki Ahepa, Thessaloniki, 54636, Greece|Thermi Clinic S.A., Thessaloniki, 57001, Greece|Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong|Lausmed Kft, Baja, 6500, Hungary|Drug Research Center Kft, Balatonfured, 8230, Hungary|Szent Margit Rendelointezet Diabetologiai Ambulancia, Budapest, 1032, Hungary|Clinexpert Kft, Budapest, 1033, Hungary|Obudai Egeszsegugyi Centrum Kft, Budapest, 1036, Hungary|Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft, Budapest, 1036, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 4032, Hungary|CRU Hungary Kft, Encs, 3860, Hungary|Borbanya Praxis Egeszsegugyi Kft, Nyiregyhaza, 4405, Hungary|Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft, Zalaegerszeg, 8900, Hungary|Azienda Universitaria Ospedaliera Consorziale Policlinico Bari, Bari, 70124, Italy|IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola, Bologna, 40138, Italy|Universita degli Studi Gabriele D Annunzio di Chieti e Pescara, Chieti, 66100, Italy|Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, 20122, Italy|Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco, Milano, 20157, Italy|IRCCS Ospedale San Raffaele, Milan, 20132, Italy|Kunisaki Makoto Clinic, Fukuoka-shi, Fukuoka, 819-0168, Japan|Nakamoto Medical Clinic, Mito-shi, Ibaraki, 310-0826, Japan|Ohishi Naika Clinic, Tsuchiura-shi, Ibaraki, 300-0835, Japan|Morinaga Ueno Clinic, Kumamoto-shi, Kumamoto, 860-0863, Japan|Midori Clinic, Nagasaki-shi, Nagasaki, 852-8034, Japan|Shiraiwa Medical Clinic, Kashiwara-shi, Osaka, 582-0005, Japan|Plumeria DM Clinic, Shizuoka-shi, Shizuoka, 422-8006, Japan|Yutenji Medical Clinic, Meguro-ku, Tokyo, 153-0053, Japan|Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, 03181, Korea, Republic of|Severance Hospital Yonsei University Health System, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|The Catholic University of Korea Seoul St Marys Hospital, Seoul, 06591, Korea, Republic of|Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska, Bialystok, 15-435, Poland|Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland|Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii, Lublin, 20-090, Poland|Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna, Staszow, 28-200, Poland|Nbr Polska Tomasz Klodawski, Warszawa, 00-710, Poland|Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska, Wroclaw, 51-162, Poland|Futuremeds spolka z ograniczona odpowiedzialnoscia, Wroclaw, 53-673, Poland|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico|Mariodiab Clinic SRL, Brasov, 500101, Romania|Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL, Bucharest, 011052, Romania|Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu, Bucuresti, 030167, Romania|Consultmed SRL, Iasi, 700544, Romania|Clinica Korall, Satu Mare, 440055, Romania|Hospital Vithas Sevilla, Castilleja de la Cuesta, Andalucía, 41950, Spain|Hospital Clinico Universitario Virgen de la Victoria, Malaga, Andalucía, 29010, Spain|Hospital Universitario Arnau de Vilanova Lleida, Lleida, Cataluña, 25198, Spain|Hospital Universitario de La Ribera, Alzira, Comunidad Valenciana, 46600, Spain|Complexo Hospitalario Universitario A Coruña, A Coruña, Galicia, 15006, Spain|Ostra Sjukhuset, Goteborg, 416 85, Sweden|Skanes universitetssjukhus, Lund, 222 42, Sweden|Universitetssjukhuset Orebro, Orebro, 703 62, Sweden|Sabbatsbergs Sjukhus, Stockholm, 113 61, Sweden|Sodersjukhuset, Stockholm, 118 83, Sweden|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 80756, Taiwan|National Cheng Kung University Hospital, Tainan, 70403, Taiwan|National Taiwan University Hospital, Taipei, 10002, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT06660173

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress