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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Combination product: Placebo; Combination product: Survodutide

• Study Type: Interventional
• Enrollment (Actual): 755
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
    • Merewether, New South Wales, Australia, 2291
      • Hunter Diabetes Centre
  • Queensland
    • Milton, Queensland, Australia, 4064
      • Core Research Group
    • Southport, Queensland, Australia, 4125
      • Griffith Health
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Monash University
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3004
      • Baker Heart and Diabetes Institute
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Keogh Institute for Medical Research
• Belgium
  • Aalst, Belgium, 9300
    • ASZ - Campus Aalst
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Roeselare, Belgium, 8800
    • Roeselare - HOSP AZ Delta
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • Centricity Research (Calgary)
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dr. James Lai
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Ltd.
    • Hamilton, Ontario, Canada, L8L 5G8
      • The Wharton Medical Clinic Clinical Trials Inc.
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research Inc.
    • Oshawa, Ontario, Canada, L1J 2K1
      • James Cha, MD
    • Stouffville, Ontario, Canada, L4A 1H2
      • Stouffville Medical Research Institute Inc.
    • Toronto, Ontario, Canada, M9V 4B4
      • Albion Finch Medical Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • Sameh Fikry Medicine Professional Corporation
  • Quebec
    • Montreal, Quebec, Canada, H1Y 3H5
      • Recherche GCP Research
    • Montreal, Quebec, Canada, H3M 1L3
      • Power Clinical Research
• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 101200
    • Beijing Pinggu Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changzhou, China, 213004
    • Changzhou Second People's Hospital
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Harbin, China, 150599
    • Forth Clinical Hospital of Harbin Medical University
  • Huzhou, China, 313000
    • Huzhou Central Hospital
  • Jinan, China, 250013
    • Center Hospital of Jinan
  • Luoyang, China, 471000
    • The First Affiliated Hospital of Henan University of Science and Technology
  • Nanjing, China, 210011
    • The Second Affiliated Hospital of Nanjing Medical University
  • Pingxiang, China, 337000
    • Pingxiang People's Hospital
  • Shanghai, China, 200240
    • Shanghai Fifth People's Hospital affiliated to Fudan University
  • Shanghai, China, 200071
    • Shanghai Municipal Hospital of Traditional Chinese Medicine
  • Siping, China, 136000
    • Siping Central People's Hospital
  • Suzhou, China, 215002
    • Suzhou Municipal Hospital
  • Tianjin, China, 30052
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430022
    • Wuhan Union Hospital
  • Xi'an, China, 710077
    • The First Affiliated Hospital of Xi'an Medical University
  • Zhengzhou, China, 100029
    • The Second Affiliated Hospital of Zhengzhou University
  • Zhenjiang, China, 212013
    • Affiliated Hospital of Jiangsu University
• Czechia
  • Broumov, Czechia, 55001
    • Edumed s.r.o
  • Olomouc, Czechia, 772 00
    • NZZ Agentura Science Pro s.r.o., Olomouc
  • Pilsen, Czechia, 301 00
    • Dieko, s.r.o.
  • Prague, Czechia, 149 00
    • Polyclinic Michnova Ltd.
  • Prague, Czechia, 190 14
    • Private Practice - Dr. Barbora Diepoltova
• Denmark
  • Gandrup, Denmark, 9362
    • Sanos Clinic Gandrup (SMO)
• Finland
  • Helsinki, Finland, 00290
    • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
  • Kuopio, Finland, 70600
    • Itä-Suomen yliopisto/Health Step Finland Oy
  • Turku, Finland, 20520
    • CRST - Clinical Research Services Turku
• Germany
  • Essen, Germany, 45136
    • InnoDiab Forschung GmbH
  • Fulda, Germany, 36037
    • MVZ im Altstadt-Caree Fulda GmbH
  • Hamburg, Germany, 22607
    • Diabetes Zentrum Hamburg West
  • Münster, Germany, 48145
    • Institut für Diabetesforschung Münster GmbH
  • Oldenburg in Holstein, Germany, 23758
    • R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
  • Witten, Germany, 58455
    • Forschungszentrum Ruhr, KliFo Center GmbH
• Greece
  • Athens, Greece, 15125
    • Athens Medical Center
  • Thermi, Greece, 57001
    • Thermi Clinic
  • Thessaloniki, Greece, 54645
    • Nexthealth S.A
• Hungary
  • Balatonfüred, Hungary, 8230
    • DRC Drug Research Ltd-Balatonfured-59734
  • Debrecen, Hungary, 4025
    • Belinus Bt
  • Kistarcsa, Hungary, 2143
    • CRU Hungary Ltd.
  • Orosháza, Hungary, 5900
    • Arina Trial Research kft.
  • Szeged, Hungary, 6725
    • University of Szeged
• Japan
  • Fukuoka, Fukuoka, Japan, 810-0066
    • Fukuhama Chuo Clinic
  • Ibaraki, Koga, Japan, 306-0232
    • Itabashi Diabetic medicine and Dermatology Clinic
  • Ibaraki, Ushiku, Japan, 300-1207
    • Nagase Clinic
  • Saitama, Soka, Japan, 340-0034
    • Soka Sugiura Naika Clinic
  • Tochigi, Oyama, Japan, 323-0022
    • Oyama East Clinic
  • Tokyo, Hachioji, Japan, 192-0083
    • Hachioji Diabetes Clinic
• Netherlands
  • Born, Netherlands, 6121 XK
    • PT & R
  • Groningen, Netherlands, 9713 EZ
    • Universitair Medisch Centrum Groningen
• New Zealand
  • Dunedin, New Zealand, 9016
    • P3 Research Dunedin
  • Nelson, New Zealand, 7011
    • Southern Clinical Trials Tasman
  • Newtown Wellington NZ, New Zealand, 6021
    • P3 Research-Newtown Wellington NZ-33770
  • Rosedale, Auckland, New Zealand, 0632
    • Optimal Clinical Trials North
  • Tauranga, New Zealand, 3110
    • P3 Research-Tauranga-34833
• Poland
  • Gdansk, Poland, 80546
    • PI HOUSE Sp. z o.o., Gdansk
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Puławy, Poland, 24-100
    • Velocity Nova Sp z o.o.
  • Siedlce, Poland, 08-110
    • ETG Siedlce
  • Tarnów, Poland, 33-100
    • METABOLICA Sp.zo.o. NZOZ METABOLICA Osrodek badan klinicznych
• South Korea
  • Bucheon-si, South Korea, 14647
    • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Goyang, South Korea, 10326
    • Dongguk University Ilsan Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 07345
    • The Catholic University of Korea, Yeouido St.Mary's Hospital
  • Suwon, South Korea, 16499
    • Ajou University Hospital
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruna
  • Castilleja de la Cuesta, Spain, 41950
    • Hospital Vithas Sevilla
  • Lleida, Spain, 25198
    • Hospital Arnau de Vilanova
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra - Madrid
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañón
  • Pamplona, Spain, 31008
    • Clínica Universidad de Navarra
  • San Cristóbal de La Laguna, Spain, 38320
    • Hospital de Canarias
• Sweden
  • Borås, Sweden, 506 30
    • Ladulaas Kliniska Studier
  • Gothenburg, Sweden, 40545
    • Forskningsenheten Carlanderska
  • Malmo, Sweden, 211 52
    • Pharmasite Malmo
  • Stockholm, Sweden, 113 61
    • Sabbatsbergs sjukhus
  • Örebro, Sweden, 70362
    • Medicinmottagning 5/Överviktsenheten
• United Kingdom
  • Blackpool, United Kingdom, FY4 3AD
    • Waterloo Medical Centre
  • Bradford-on-Avon, United Kingdom, BA15 1DQ
    • Bradford on Avon Health Centre
  • Hayle, United Kingdom, TR27 5DT
    • Mounts Bay Medical Limited
  • Rotherham, United Kingdom, S65 1DA
    • Clifton Medical Centre, Rotherham
  • Trowbridge, United Kingdom, BA14 8LW
    • Trowbridge Health Centre
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • EmVenio Research-Atlanta-69582
  • California
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research, Spring Valley
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Florida
    • Doral, Florida, United States, 33172
      • Alliance for Multispecialty Research, LLC - Doral
    • Gainesville, Florida, United States, 32610
      • University Of Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC - Jacksonville
    • Miami, Florida, United States, 33165
      • New Horizon Research Center-Miami-69732
    • Ocoee, Florida, United States, 34761
      • West Orange Endocrinology
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Evanston Premier Healthcare Research LLC
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research-Valparaiso-68883
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research-Sioux City-69728
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • AMR Lexington
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research, LLC
  • New Jersey
    • Atlantic City, New Jersey, United States, 08401
      • Walgreens Clinical Trials-Atlantic City-69647
    • Perth Amboy, New Jersey, United States, 08861
      • Walgreens - Perth Amboy - Site 4544
    • Trenton, New Jersey, United States, 08611
      • Premier Research, Inc.
  • New York
    • Binghamton, New York, United States, 13905
      • Velocity Clinical Research - Binghamton
    • West Seneca, New York, United States, 14224
      • Southgate Medical Group/ Southgate Medical Park
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East, PA
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc.
    • Wilmington, North Carolina, United States, 28401
      • Accellacare-Wilmington-67123
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73139
      • EmVenio Research-Oklahoma City-70053
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Trial Management Associates
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology
    • Houston, Texas, United States, 77040
      • Juno Research, LLC
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease Clinic, P.A.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Combination product: Placebo; once weekly subcutaneous injection, pre-filled syringe
Experimental: Survodutide 3.6 mg	Combination product: Survodutide; once weekly subcutaneous injection, pre-filled syringe; Other Names: BI 456906
Experimental: Survodutide 6.0 mg	Combination product: Survodutide; once weekly subcutaneous injection, pre-filled syringe; Other Names: BI 456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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 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 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 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 body weight (kg)		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 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): December 12, 2025
• Study Completion (Actual): March 27, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; BI 456906
• Other Study ID Numbers: 1404-0041; 2022-502531-18-00 (Registry Identifier: CTIS); U1111-1289-0247 (Registry Identifier: WHO registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No