A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
SYNCHRONIZE™-2
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
3 other identifiers
interventional
755
19 countries
143
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Nov 2023
Typical duration for phase_3 obesity
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2026
CompletedApril 24, 2026
April 1, 2026
2 years
September 27, 2023
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (22)
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
- +17 more secondary outcomes
Study Arms (3)
Survodutide 3.6 mg
EXPERIMENTALSurvodutide 6.0 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
once weekly subcutaneous injection, pre-filled syringe
Eligibility Criteria
You may qualify if:
- 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) ≥27 kg/m\^2 at screening.
- 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.
- HbA1c ≥6.5% (≥48 mmol/mol) and \<10% (\<86 mmol/mol) as measured by the central laboratory at screening.
- Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
You may not qualify if:
- Body weight change (self-reported) of \>5% within 3 months before screening.
- Treatment with any medication for the indication obesity within 3 months before screening.
- Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
- 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.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (143)
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, 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
Malmo, 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
Related Publications (1)
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.
PMID: 41216778DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 4, 2023
Study Start
November 27, 2023
Primary Completion
December 12, 2025
Study Completion
March 27, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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.