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Clinical Trial Details

Trial ID: L6414
Source ID: NCT06066528
Associated Drug: Survodutide
Title: A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Acronym: SYNCHRONIZE™-2
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Obesity|Diabetes Mellitus, Type 2
Interventions: DRUG: Survodutide|DRUG: Placebo
Outcome Measures: Primary: Percentage change in body weight from baseline to Week 76, Baseline and at Week 76|Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76, Baseline and at Week 76 | Secondary: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76, Baseline and at Week 76|Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76, Baseline and at Week 76|Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76, Baseline and at Week 76|Absolute change from baseline to Week 76 in body weight (kg), Baseline and at Week 76|Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%), Baseline and at Week 76|Absolute change from baseline to Week 76 in waist circumference (cm), Baseline and at Week 76|Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg), Baseline and at Week 76|Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO), "Capacity to Resist" domain score of the Eating Behaviour PRO is ranging between 0 and 24 and a higher score indicates a lower capacity to resist., Baseline and at Week 76|Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score, Eating Behaviour PRO total score is ranging between 0 and 48 and a higher score indicates a worse eating behaviour (greater desire to eat and/or lower capacity to resist)., Baseline and at Week 76|Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2), Baseline and at Week 76|Absolute change from baseline to Week 76 in HbA1c (mmol/mol), Baseline and at Week 76|Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg), Baseline and at Week 76|Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L), Baseline and at Week 76|Absolute change from baseline to Week 76 in total cholesterol (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in triglycerides (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in free fatty acids (mg/dL), Baseline and at Week 76|Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L), Baseline and at Week 76|Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L), Baseline and at Week 76
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 756
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-27
Completion Date: 2026-04-03
Results First Posted:
Last Update Posted: 2025-02-28
Locations: Pinnacle Research Group, LLC, Anniston, Alabama, 36207, United States|EmVenio Research-Atlanta-69582, Phoenix, Arizona, 85032, United States|Encompass Clinical Research, Spring Valley, Spring Valley, California, 91978, United States|Diablo Clinical Research, Walnut Creek, California, 94598, United States|Alliance for Multispecialty Research-Coral Gables-68872, Coral Gables, Florida, 33134, United States|University of Florida, Gainesville, Florida, 32610, United States|East Coast Institute for Research, LLC-Jacksonville-55146, Jacksonville, Florida, 32216, United States|New Horizon Research Center-Miami-69732, Miami, Florida, 33165, United States|West Orange Endocrinology, Ocoee, Florida, 34761, United States|Emory University, Atlanta, Georgia, 30303, United States|East-West Medical Research, Honolulu, Hawaii, 96814, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Evanston Premier Healthcare Research LLC, Skokie, Illinois, 60077, United States|Velocity Clinical Research-Valparaiso-68883, Valparaiso, Indiana, 46383, United States|Velocity Clinical Research-Sioux City-69728, Sioux City, Iowa, 51106, United States|AMR Lexington, Lexington, Kentucky, 40509, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|StudyMetrix Research, LLC, Saint Peters, Missouri, 63303, United States|Walgreens Clinical Trials-Atlantic City-69647, Atlantic City, New Jersey, 08401, United States|Walgreens Clinical Trials-Perth Amboy-69648, Perth Amboy, New Jersey, 08861, United States|Premier Research, Inc., Trenton, New Jersey, 08611, United States|Velocity Clinical Research, Vestal, Vestal, New York, 13850, United States|Southgate Medical Group/ Southgate Medical Park, West Seneca, New York, 14224, United States|Physicians East, PA, Greenville, North Carolina, 27834, United States|Lucas Research, Inc., Morehead City, North Carolina, 28557, United States|Accellacare-Wilmington-67123, Wilmington, North Carolina, 28401, United States|EmVenio Research-Oklahoma City-70053, Oklahoma City, Oklahoma, 73139, United States|Trial Management Associates, Myrtle Beach, South Carolina, 29572, United States|Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States|Juno Research, LLC, Houston, Texas, 77040, United States|Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Nepean Hospital, Kingswood, New South Wales, 2747, Australia|Hunter Diabetes Centre, Merewether, New South Wales, 2291, Australia|CORE Research Group, Milton, Queensland, 4064, Australia|Griffith Health, Southport, Queensland, 4125, Australia|Monash University, Box Hill, Victoria, 3128, Australia|Austin Health, Heidelberg, Victoria, 3084, Australia|Baker Heart and Diabetes Institute, Melbourne, Victoria, 3004, Australia|Keogh Institute for Medical Research, Nedlands, Western Australia, 6009, Australia|ASZ - Campus Aalst, Aalst, 9300, Belgium|UZ Leuven, Leuven, 3000, Belgium|Roeselare - HOSP AZ Delta, Roeselare, 8800, Belgium|Centricity Research (Calgary), Calgary, Alberta, T2H 2G4, Canada|Dr. James Lai, Vancouver, British Columbia, V5Z 4E1, Canada|Aggarwal and Associates Ltd., Brampton, Ontario, L6T 0G1, Canada|The Wharton Medical Clinic Clinical Trials Inc., Hamilton, Ontario, L8L 5G8, Canada|Milestone Research Inc., London, Ontario, N5W 6A2, Canada|James Cha, MD, Oshawa, Ontario, L1J 2K1, Canada|Stouffville Medical Centre, Stouffville, Ontario, L4A 1H2, Canada|Albion Finch Medical Centre, Toronto, Ontario, M9V 4B4, Canada|Sameh Fikry Medicine Professional Corporation, Waterloo, Ontario, N2J 1C4, Canada|Recherche GCP Research, Montreal, Quebec, H1Y 3H5, Canada|Power Clinical Research, Montreal, Quebec, H3M 1L3, Canada|Peking University People's Hospital, Beijing, 100044, China|Beijing Pinggu Hospital, Beijing, 101200, China|The First Hospital of Jilin University, Changchun, 130021, China|Changzhou Second People's Hospital, Changzhou, 213004, China|Guangdong Provincial People's Hospital, Guangzhou, 510080, China|Forth Clinical Hospital of Harbin Medical University, Harbin, 150599, China|Huzhou Central Hospital, Huzhou, 313000, China|Center Hospital of Jinan, Jinan, 250013, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, 471000, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China|Pingxiang People's Hospital, Pingxiang, 337000, China|Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, 200071, China|Shanghai Fifth People's Hospital affiliated to Fudan University, Shanghai, 200240, China|Siping Central People's Hospital, Siping, 136000, China|Suzhou Municipal Hospital, Suzhou, 215002, China|Tianjin Medical University General Hospital, Tianjin, 30052, China|Wuhan Union Hospital, Wuhan, 430022, China|The First Affiliated Hospital of Xi'an Medical University, Xi'an, 710077, China|The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, 100029, China|Affiliated Hospital of Jiangsu University, Zhenjiang, 212013, China|EDUMED s.r.o., Nachod, 54701, Czechia|NZZ Agentura Science Pro s.r.o., Olomouc, Olomouc, 772 00, Czechia|Dieko, s.r.o., Pilsen, 301 00, Czechia|Polyclinic Michnova Ltd., Prague, 149 00, Czechia|Private Practice - Dr. Barbora Diepoltova, Prague, 190 14, Czechia|Sanos Clinic Gandrup (SMO), Gandrup, 9362, Denmark|HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki, Helsinki, 00290, Finland|Itä-Suomen yliopisto/Health Step Finland Oy, Kuopio, 70210, Finland|CRST - Clinical Research Services Turku, Turku, 20520, Finland|InnoDiab Forschung GmbH, Essen, 45136, Germany|MVZ im Altstadt-Caree Fulda GmbH, Fulda, 36037, Germany|Diabetes Zentrum Hamburg West, Hamburg, 22607, Germany|Institut für Diabetesforschung Münster GmbH, Münster, 48145, Germany|RED Institut GmbH, Oldenburg, 23758, Germany|Forschungszentrum Ruhr, KliFo Center GmbH, Witten, 58455, Germany|Athens Medical Center, Athens, 15125, Greece|Thermi Clinic, Thermi, 57001, Greece|Euromedica General Clinic of Thessaloniki, Thessaloniki, 54645, Greece|DRC Drug Research Ltd-Balatonfured-59734, Balatonfured, 8230, Hungary|Belinus Bt, Debrecen, 4025, Hungary|CRU Hungary Ltd., Kistarcsa, 2143, Hungary|Arina Trial Research kft., Oroshaza, 5900, Hungary|University of Szeged, Szeged, 6725, Hungary|Fukuhama Chuo Clinic, Fukuoka, Fukuoka, 810-0066, Japan|Itabashi Diabetic medicine and Dermatology Clinic, Ibaraki, Koga, 306-0232, Japan|Noritake Clinic, Ibaraki, Ushiku, 300-1207, Japan|Soka Sugiura Naika Clinic, Saitama, Soka, 340-0034, Japan|Oyama East Clinic, Tochigi, Oyama, 323-0022, Japan|Hachioji Diabetes Clinic, Tokyo, Hachioji, 192-0083, Japan|The Catholic University of Korea, Bucheon St.Mary's Hospital, Bucheon, 14647, Korea, Republic of|Kyungpook National Univ. Hosp, Daegu, 700-721, Korea, Republic of|Dongguk University Ilsan Hospital, Goyang, 10326, Korea, Republic of|Gachon University Gil Medical Center, Incheon, 21565, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam, 13620, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Severance Hospital, Seoul, 03722, Korea, Republic of|The Catholic University of Korea, Yeouido St.Mary's Hospital, Seoul, 07345, Korea, Republic of|Ajou University Hospital, Suwon, 16499, Korea, Republic of|PT & R, Born, 6121 XK, Netherlands|Universitair Medisch Centrum Groningen, Groningen, 9713 EZ, Netherlands|P3 Research Dunedin, Dunedin, 9016, New Zealand|Southern Clinical Trials Tasman, Nelson, 7011, New Zealand|P3 Research-Newtown Wellington NZ-33770, Newtown Wellington NZ, 6021, New Zealand|Optimal Clinical Trials North, Rosedale, Auckland, 0632, New Zealand|P3 Research-Tauranga-34833, Tauranga, 3110, New Zealand|PI HOUSE Sp. z o.o., Gdansk, Gdansk, 80546, Poland|ETG Lublin, Lublin, 20-412, Poland|Velocity Nova Sp z o.o., Pulawy, 24-100, Poland|ETG Siedlce, Siedlce, 08-110, Poland|Clinical Research Center METABOLICA lek. Robert Witek, Tarnow, 33-100, Poland|Hospital A Coruña, A Coruña, 15006, Spain|Hospital Vithas Sevilla, Castilleja de la Cuesta, 41950, Spain|Hospital Arnau de Vilanova-Lleida-17625, Lleida, 25198, Spain|Hospital General Universitario Gregorio Marañón, Madrid, 28009, Spain|Clínica Universidad de Navarra - Madrid, Madrid, 28027, Spain|Clínica Universidad de Navarra, Pamplona, 31008, Spain|Hospital de Canarias, San Cristóbal de La Laguna, 38320, Spain|Ladulaas Kliniska Studier, Borås, 506 30, Sweden|Forskningsenheten Carlanderska, Göteborg, 40545, Sweden|Pharmasite Malmo, Malmö, 211 52, Sweden|Sabbatsbergs sjukhus, Stockhom, 113 61, Sweden|Medicinmottagning 5/Överviktsenheten, Örebro, 70362, Sweden|Waterloo Medical Centre, Blackpool, FY4 3AD, United Kingdom|Bradford on Avon Health Centre, Bradford on Avon, BA15 1DQ, United Kingdom|Mounts Bay Medical Limited, Hayle, TR27 5DT, United Kingdom|Clifton Medical Centre, Rotherham, Rotherham, S65 1DA, United Kingdom|Trowbridge Health Centre, Trowbridge, BA14 8LW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT06066528

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress