A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (SYNCHRONIZE™-1)

March 11, 2026 updated by: Boehringer Ingelheim

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 Without Type 2 Diabetes

This study is open to adults who are at least 18 years old and have

  • a body mass index (BMI) of 30 kg/m² or more, or
  • a BMI of 27 kg/m² or more and at least one health problem related to their weight.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

726

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • 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
      • Edegem, Belgium, 2650
        • Edegem - UNIV UZ Antwerpen
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Roeselare, Belgium, 8800
        • Roeselare - HOSP AZ Delta
  • Canada
    • 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
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • ViaCar Recherches Cliniques Inc. (Greenfield Park)
      • 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
      • 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
  • Finland
      • Helsinki, Finland, 00290
        • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
      • Jyväskylä, Finland, 40620
        • StudyCor Oy
      • 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
  • Japan
      • Fukuoka, Fukuoka, Japan, 810-0066
        • Fukuhama Chuo Clinic
      • Hyogo, Kobe, Japan, 650-0017
        • Kobe University Hospital
      • Ibaraki, Ushiku, Japan, 300-1207
        • Noritake Clinic
      • Saitama, Soka, Japan, 340-0034
        • Soka Sugiura Naika Clinic
      • Tokyo, Hachioji, Japan, 192-0083
        • Hachioji Diabetes Clinic
  • Netherlands
      • Born, Netherlands, 6121 XK
        • PT & R
      • Groningen, Netherlands, 9713 EZ
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3045 PM
        • Franciscus Gasthuis
  • 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, 80-546
        • 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
        • Clinical Research Center METABOLICA lek. Robert Witek
  • 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
      • Seoul, South Korea, 110-746
        • Kangbuk Samsung Hospital
      • Suwon, South Korea, 16499
        • Ajou University Hospital
  • Sweden
      • Borås, Sweden, 506 30
        • Ladulaas Kliniska Studier
      • Gothenburg, Sweden, 40545
        • Forskningsenheten Carlanderska
      • 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
      • Burbage, Hinkley, United Kingdom, LE10 2SE
        • Burbage Surgery
      • Nantwich, United Kingdom, CW5 5NX
        • Kiltearn Medical Centre
      • Rotherham, United Kingdom, S65 1DA
        • Clifton Medical Centre, Rotherham
      • Trowbridge, United Kingdom, BA14 8LW
        • Trowbridge Health Centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • EmVenio Research-Phoenix-69743
    • California
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research, Spring Valley
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Medicine
    • 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
    • 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
      • 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
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Valley Weight Loss Clinic
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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) ≥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,:

    • Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)
    • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (HDL) cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL cholesterol 50 mg/dL (<1.3 mmol/L) for women)
    • Obstructive sleep apnoea
    • Others.
  3. 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. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
  4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.
  5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
  6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
  7. History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening.
  8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Combination product: Placebo
once weekly subcutaneous injection
Experimental: Survodutide 3.6 mg
Combination product: survodutide
once weekly subcutaneous injection
Other Names:
  • BI 456906
Experimental: Survodutide 6.0 mg
Combination product: survodutide
once weekly subcutaneous injection
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
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Time Frame: Baseline and at 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
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in body weight (kg)
Time Frame: Baseline and Week 76
Baseline and Week 76
Absolute change from baseline to Week 76 in waist circumference (cm)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Time Frame: Baseline and at Week 76
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)
Time Frame: Baseline and at Week 76
"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
Time Frame: Baseline and at Week 76
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)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Relative change from baseline to Week 76 in liver fat content (%)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in total fat volume (L)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in lean body volume (L)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in visceral fat volume (L)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in subcutaneous fat volume (L)
Time Frame: Baseline and at Week 76.
Baseline and at Week 76.
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Relative change from baseline to Week 76 in total fat volume (%)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Relative change from baseline to Week 76 in lean body volume (%)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Relative change from baseline to Week 76 in visceral fat volume (%)
Time Frame: Baseline and at Week 76
Baseline and at Week 76
Relative change from baseline to Week 76 in subcutaneous fat volume (%)
Time Frame: Baseline and at Week 76.
Baseline and at Week 76.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2023

Primary Completion (Actual)

December 2, 2025

Study Completion (Actual)

February 20, 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)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-0038
  • U1111-1288-9400 (Registry Identifier: WHO registry)
  • 2022-502529-17-00 (Registry Identifier: CTIS)

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.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.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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