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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502531-18-00 | Registry Identifier | CTIS | |
| U1111-1289-0247 | Registry Identifier | WHO registry |
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This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight.
Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survodutide 3.6 mg | Experimental |
| |
| Survodutide 6.0 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survodutide | Combination Product | once weekly subcutaneous injection, pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria apply.](streamdown:incomplete-link)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| EmVenio Research-Atlanta-69582 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41216778 | Derived | Wharton S, le Roux CW, Bozkurt B, Platz E, Bleckert G, Ajaz Hussain S, Brueckmann M, Startseva E, Kloer IM, Kaplan LM. Baseline characteristics in the SYNCHRONIZE-2 randomized phase 3 trial of survodutide, a glucagon receptor/GLP-1 receptor dual agonist, for obesity in people with type 2 diabetes. Diabetes Obes Metab. 2026 Feb;28(2):1490-1498. doi: 10.1111/dom.70263. Epub 2025 Nov 11. |
| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| Placebo | Combination Product | once weekly subcutaneous injection, pre-filled syringe |
|
| 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 |
| 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, LLC - Doral | Doral | Florida | 33172 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| East Coast Institute for Research, LLC - Jacksonville | 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 | City of Saint Peters | Missouri | 63303 | United States |
| Walgreens Clinical Trials-Atlantic City-69647 | Atlantic City | New Jersey | 08401 | United States |
| Walgreens - Perth Amboy - Site 4544 | Perth Amboy | New Jersey | 08861 | United States |
| Premier Research, Inc. | Trenton | New Jersey | 08611 | United States |
| Velocity Clinical Research - Binghamton | Binghamton | New York | 13905 | 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 Research Institute Inc. | 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 | Broumov | 55001 | 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 | 70600 | 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 |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH | Oldenburg in Holstein | 23758 | Germany |
| Forschungszentrum Ruhr, KliFo Center GmbH | Witten | 58455 | Germany |
| Athens Medical Center | Athens | 15125 | Greece |
| Thermi Clinic | Thermi | 57001 | Greece |
| Nexthealth S.A | Thessaloniki | 54645 | Greece |
| DRC Drug Research Ltd-Balatonfured-59734 | Balatonfüred | 8230 | Hungary |
| Belinus Bt | Debrecen | 4025 | Hungary |
| CRU Hungary Ltd. | Kistarcsa | 2143 | Hungary |
| Arina Trial Research kft. | Orosháza | 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 |
| Nagase 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 |
| 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. | Puławy | 24-100 | Poland |
| ETG Siedlce | Siedlce | 08-110 | Poland |
| METABOLICA Sp.zo.o. NZOZ METABOLICA Osrodek badan klinicznych | Tarnów | 33-100 | Poland |
| The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon-si | 14647 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Dongguk University Ilsan Hospital | Goyang | 10326 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| The Catholic University of Korea, Yeouido St.Mary's Hospital | Seoul | 07345 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Vithas Sevilla | Castilleja de la Cuesta | 41950 | Spain |
| Hospital Arnau de Vilanova | 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 | Gothenburg | 40545 | Sweden |
| Pharmasite Malmo | Malmö | 211 52 | Sweden |
| Medicinmottagning 5/Överviktsenheten | Örebro | 70362 | Sweden |
| Sabbatsbergs sjukhus | Stockholm | 113 61 | 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000726451 | BI 456906 |
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