Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1288-9400 | Registry Identifier | WHO registry | |
| 2022-502529-17-00 | Registry Identifier | CTIS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is open to adults who are at least 18 years old and have
People with type 2 diabetes cannot take part in this study. 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 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 participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
Not provided
Inclusion Criteria:
Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
Body mass index (BMI) ≥30 kg/m^2 at screening, OR BMI ≥27 kg/m^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
History of at least one self-reported unsuccessful dietary effort to lose body weight.
Further inclusion criteria apply.
Exclusion Criteria:
Further exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EmVenio Research-Phoenix-69743 | Phoenix | Arizona | 85032 | United States | ||
| Encompass Clinical Research, Spring Valley |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42253238 | Derived | le Roux CW, Wharton S, Startseva E, Kloer IM, Hussain SA, Unseld A, Bozkurt B, Ard JD, Bays HE, Bogdanski P, Ekinci EI, Jastreboff AM, Ji L, Ogawa W, Pedersen SD, Pietilainen KH, Sattar N, Seufert J, Stenlof K, van Beek AP, Vangoitsenhoven R, Brueckmann M, Younes R, Kaplan LM; SYNCHRONIZE-1 Investigators. Survodutide Once Weekly for the Treatment of Adults with Obesity. N Engl J Med. 2026 Jun 7. doi: 10.1056/NEJMoa2600751. Online ahead of print. | |
| 41187967 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Combination Product | once weekly subcutaneous injection |
|
| 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 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 the 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 |
| 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 diastolic blood pressure (DBP) (mmHg) | 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 HbA1c (mmol/mol) | 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 |
| Absolute change from baseline to Week 76 in total fat volume (L) | Baseline and at Week 76 |
| Absolute change from baseline to Week 76 in lean body volume (L) | Baseline and at Week 76 |
| Absolute change from baseline to Week 76 in visceral fat volume (L) | Baseline and at Week 76 |
| Absolute change from baseline to Week 76 in subcutaneous fat volume (L) | Baseline and at Week 76. |
| Relative change from baseline to Week 76 in total fat volume (%) | Baseline and at Week 76 |
| Relative change from baseline to Week 76 in lean body volume (%) | Baseline and at Week 76 |
| Relative change from baseline to Week 76 in visceral fat volume (%) | Baseline and at Week 76 |
| Relative change from baseline to Week 76 in subcutaneous fat volume (%) | Baseline and at Week 76. |
| Relative change from baseline to Week 76 in liver fat content (%) | Baseline and at Week 76 |
| Spring Valley |
| California |
| 91978 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | 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 |
| 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 |
| 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 |
| Valley Weight Loss Clinic | Fargo | North Dakota | 58104 | 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 |
| 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 |
| Edegem - UNIV UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Roeselare - HOSP AZ Delta | Roeselare | 8800 | Belgium |
| 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 |
| ViaCar Recherches Cliniques Inc. (Greenfield Park) | Greenfield Park | Quebec | J4V 2G8 | 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 |
| 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 |
| HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki | Helsinki | 00290 | Finland |
| StudyCor Oy | Jyväskylä | 40620 | 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 |
| Fukuhama Chuo Clinic | Fukuoka, Fukuoka | 810-0066 | Japan |
| Kobe University Hospital | Hyogo, Kobe | 650-0017 | Japan |
| Noritake Clinic | Ibaraki, Ushiku | 300-1207 | Japan |
| Soka Sugiura Naika Clinic | Saitama, Soka | 340-0034 | Japan |
| Hachioji Diabetes Clinic | Tokyo, Hachioji | 192-0083 | Japan |
| PT & R | Born | 6121 XK | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 EZ | Netherlands |
| Franciscus Gasthuis | Rotterdam | 3045 PM | 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 | 80-546 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Velocity Nova Sp z o.o. | Puławy | 24-100 | Poland |
| ETG Siedlce | Siedlce | 08-110 | Poland |
| Clinical Research Center METABOLICA lek. Robert Witek | 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 |
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Ladulaas Kliniska Studier | Borås | 506 30 | Sweden |
| Forskningsenheten Carlanderska | Gothenburg | 40545 | 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 |
| Burbage Surgery | Burbage, Hinkley | LE10 2SE | United Kingdom |
| Kiltearn Medical Centre | Nantwich | CW5 5NX | United Kingdom |
| Clifton Medical Centre, Rotherham | Rotherham | S65 1DA | United Kingdom |
| Trowbridge Health Centre | Trowbridge | BA14 8LW | United Kingdom |
| Derived |
| le Roux CW, Wharton S, Bozkurt B, Platz E, Bleckert G, Ajaz Hussain S, Brueckmann M, Startseva E, Kloer IM, Kaplan LM. Survodutide for treatment of obesity: Baseline characteristics of participants in a randomized, double-blind, placebo-controlled, phase 3 trial (SYNCHRONIZE-1). Diabetes Obes Metab. 2026 Jan;28(1):337-346. doi: 10.1111/dom.70196. Epub 2025 Nov 4. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000726451 | BI 456906 |
Not provided
Not provided
Not provided