Obesity Clinical Trial
— SYNCHRONIZE™-2Official title:
A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes Mellitus
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | January 16, 2026 |
Est. primary completion date | December 19, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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. 2. Body mass index (BMI) =27 kg/m^2 at screening. 3. Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) =6.5% [=48 mmol/mol]) at least 180 days prior to screening. 4. HbA1c =6.5% (=48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening. 5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines. 6. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply. Exclusion Criteria: 1. Body weight change (self-reported) of >5% within 3 months before screening. 2. Treatment with any medication for the indication obesity within 3 months before screening. 3. Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor [DPP-4il). 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). 5. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x upper limit of normal (ULN)) as measured by the central laboratory at screening. 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). Further exclusion criteria apply. |
Country | Name | City | State |
---|---|---|---|
Australia | Monash University | Box Hill | Victoria |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Nepean Hospital | Kingswood | New South Wales |
Australia | Baker Heart and Diabetes Institute | Melbourne | Victoria |
Australia | Hunter Diabetes Centre | Merewether | New South Wales |
Australia | CORE Research Group | Milton | Queensland |
Australia | Keogh Institute for Medical Research | Nedlands | Western Australia |
Australia | Griffith Health | Southport | Queensland |
Belgium | ASZ - Campus Aalst | Aalst | |
Belgium | Brussels - UNIV UZ Brussel | Jette | |
Belgium | UZ Leuven | Leuven | |
Belgium | Roeselare - HOSP AZ Delta | Roeselare | |
Canada | Aggarwal and Associates Ltd. | Brampton | Ontario |
Canada | Centricity Research (Calgary) | Calgary | Alberta |
Canada | The Wharton Medical Clinic Clinical Trials Inc. | Hamilton | Ontario |
Canada | Milestone Research Inc. | London | Ontario |
Canada | Power Clinical Research | Montreal | Quebec |
Canada | Recherche GCP Research | Montreal | Quebec |
Canada | James Cha, MD | Oshawa | Ontario |
Canada | Stouffville Medical Centre | Stouffville | Ontario |
Canada | Albion Finch Medical Centre | Toronto | Ontario |
Canada | Dr. James Lai | Vancouver | British Columbia |
Canada | Sameh Fikry Medicine Professional Corporation | Waterloo | Ontario |
China | Beijing Pinggu Hospital | Beijing | |
China | Peking University People's Hospital | Beijing | |
China | The First Hospital of Jilin University | Changchun | |
China | Changzhou Second People's Hospital | Changzhou | |
China | Guangdong Provincial People's Hospital | Guangzhou | |
China | The Second Affiliated Hospital of Nanjing Medical University | Hangzhou | |
China | Forth Clinical Hospital of Harbin Medical University | Harbin | |
China | 2nd Hospital Affiliated to Zhengzhou University | Henan Province | |
China | Huzhou Central Hospital | Huzhou | |
China | Center Hospital of Jinan | Jinan | |
China | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | |
China | Pingxiang People's Hospital | Pingxiang | |
China | Shanghai Fifth People's Hospital affiliated to Fudan University | Shanghai | |
China | Shanghai Municipal Hospital of Traditional Chinese Medicine | Shanghai | |
China | Siping Central People's Hospital | Siping | |
China | Suzhou Municipal Hospital | Suzhou | |
China | Tianjin Medical University General Hospital | Tianjin | |
China | Wuhan Union Hospital | Wuhan | |
China | The First Affiliated Hospital of Xi'an Medical University | Xi'an | |
China | Affiliated Hospital of Jiangsu University | Zhenjiang | |
Czechia | EDUMED s.r.o. | Nachod | |
Czechia | NZZ Agentura Science Pro s.r.o., Olomouc | Olomouc | |
Czechia | Dieko, s.r.o. | Pilsen | |
Czechia | Polyclinic Michnova Ltd. | Prague | |
Czechia | Private Practice - Dr. Barbora Diepoltova | Prague | |
Denmark | Sanos Clinic Gandrup (SMO) | Gandrup | |
Finland | HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki | Helsinki | |
Finland | Itä-Suomen yliopisto/Health Step Finland Oy | Kuopio | |
Finland | CRST - Clinical Research Services Turku | Turku | |
Germany | InnoDiab Forschung GmbH | Essen | |
Germany | MVZ im Altstadt-Caree Fulda GmbH | Fulda | |
Germany | Diabetes Zentrum Hamburg West | Hamburg | |
Germany | Institut für Diabetesforschung Münster GmbH | Münster | |
Germany | RED Institut GmbH | Oldenburg | |
Germany | Forschungszentrum Ruhr, KliFo Center GmbH | Witten | |
Greece | Athens Medical Center | Athens | |
Greece | Thermi Clinic | Thermi | |
Greece | Euromedica General Clinic of Thessaloniki | Thessaloniki | |
Hungary | DRC Drug Research Ltd | Balatonfured | |
Hungary | Belinus Bt | Debrecen | |
Hungary | CRU Hungary Ltd. | Kistarcsa | |
Hungary | Arina Trial Research kft. | Oroshaza | |
Hungary | University of Szeged | Szeged | |
Japan | Fukuhama Chuo Clinic | Fukuoka, Fukuoka | |
Japan | Itabashi Diabetic medicine and Dermatology Clinic | Ibaraki, Koga | |
Japan | Noritake Clinic | Ibaraki, Ushiku | |
Japan | Soka Sugiura Naika Clinic | Saitama, Soka | |
Japan | Oyama East Clinic | Tochigi, Oyama | |
Japan | Hachioji Diabetes Clinic | Tokyo, Hachioji | |
Korea, Republic of | The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon | |
Korea, Republic of | Kyungpook National Univ. Hosp | Daegu | |
Korea, Republic of | Dongguk University Ilsan Hospital | Goyang | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Yeouido St.Mary's Hospital | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon | |
Netherlands | PT & R | Born | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
New Zealand | P3 Research Dunedin | Dunedin | |
New Zealand | Southern Clinical Trials Tasman | Nelson | |
New Zealand | P3 Research | Newtown Wellington NZ | |
New Zealand | Optimal Clinical Trials North | Rosedale, Auckland | |
New Zealand | P3 Research | Tauranga | |
Poland | PI HOUSE Sp. z o.o., Gdansk | Gdansk | |
Poland | ETG Lublin | Lublin | |
Poland | Velocity Nova Sp z o.o. | Pulawy | |
Poland | ETG Siedlce | Siedlce | |
Poland | Clinical Research Center METABOLICA lek. Robert Witek | Tarnow | |
Spain | Hospital A Coruña | A Coruña | |
Spain | Hospital Vithas Sevilla | Castilleja de la Cuesta | |
Spain | Hospital Arnau de Vilanova | Lleida | |
Spain | Clínica Universidad de Navarra - Madrid | Madrid | |
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Clínica Universidad de Navarra | Pamplona | |
Spain | Hospital de Canarias | San Cristóbal de La Laguna | |
Sweden | Ladulaas Kliniska Studier | Borås | |
Sweden | Forskningsenheten Carlanderska | Göteborg | |
Sweden | Pharmasite Malmo | Malmö | |
Sweden | Medicinmottagning 5/Överviktsenheten | Örebro | |
Sweden | Sabbatsbergs sjukhus | Stockhom | |
United Kingdom | Waterloo Medical Centre | Blackpool | |
United Kingdom | Bradford on Avon Health Centre | Bradford on Avon | |
United Kingdom | Mounts Bay Medical Ltd | Hayle | |
United Kingdom | Clifton Medical Centre, Rotherham | Rotherham | |
United Kingdom | Trowbridge Health Centre | Trowbridge | |
United States | Pinnacle Research Group, LLC | Anniston | Alabama |
United States | Emory University | Atlanta | Georgia |
United States | Walgreens Clinical Trials | Atlantic City | New Jersey |
United States | Texas Diabetes and Endocrinology | Austin | Texas |
United States | Alliance for Multispecialty Research | Coral Gables | Florida |
United States | Valley Weight Loss Clinic | Fargo | North Dakota |
United States | University of Florida | Gainesville | Florida |
United States | Physicians East, PA | Greenville | North Carolina |
United States | East-West Medical Research | Honolulu | Hawaii |
United States | Juno Research, LLC | Houston | Texas |
United States | East Coast Institute for Research, LLC | Jacksonville | Florida |
United States | AMR Lexington | Lexington | Kentucky |
United States | L-MARC Research Center | Louisville | Kentucky |
United States | Manassas Clinical Research Center | Manassas | Virginia |
United States | Solaris Clinical Research | Meridian | Idaho |
United States | New Horizon Research Center | Miami | Florida |
United States | Lucas Research, Inc. | Morehead City | North Carolina |
United States | Trial Management Associates | Myrtle Beach | South Carolina |
United States | West Orange Endocrinology | Ocoee | Florida |
United States | EmVenio Research | Oklahoma City | Oklahoma |
United States | Walgreens Clinical Trials | Perth Amboy | New Jersey |
United States | EmVenio Research | Phoenix | Arizona |
United States | Rainier Clinical Research Center | Renton | Washington |
United States | StudyMetrix Research, LLC | Saint Peters | Missouri |
United States | Diabetes & Glandular Disease Clinic, P.A. | San Antonio | Texas |
United States | Consano Clinical Research | Shavano Park | Texas |
United States | Velocity Clinical Research | Sioux City | Iowa |
United States | Evanston Premier Healthcare Research LLC | Skokie | Illinois |
United States | Encompass Clinical Research, Spring Valley | Spring Valley | California |
United States | Premier Research, Inc. | Trenton | New Jersey |
United States | Velocity Clinical Research | Valparaiso | Indiana |
United States | Velocity Clinical Research, Vestal | Vestal | New York |
United States | Diablo Clinical Research | Walnut Creek | California |
United States | Southgate Medical Group/ Southgate Medical Park | West Seneca | New York |
United States | Accellacare | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Australia, Belgium, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Hungary, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage change in body weight from baseline to Week 76 | Baseline and at Week 76 | ||
Primary | 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 | ||
Secondary | Achievement of body weight reduction =15% (yes/no) from baseline to Week 76 | Baseline and at Week 76 | ||
Secondary | Achievement of body weight reduction =20% (yes/no) from baseline to Week 76 | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in body weight (kg) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in waist circumference (cm) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg) | Baseline and at Week 76 | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in HbA1c (mmol/mol) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in total cholesterol (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in triglycerides (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in free fatty acids (mg/dL) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L) | Baseline and at Week 76 | ||
Secondary | Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L) | Baseline and at Week 76 |
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