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ObesityPhase 3SYNCHRONIZE™-1NCT06066515

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

A Phase 3 study testing survodutide in people with Obesity, run by Boehringer Ingelheim at 118 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
survodutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
726 participants
Where
118 sitesin 14 countries
Study dates
25 Nov 2023to 20 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,:
  • 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.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.
  • Further inclusion criteria apply.

Who cannot join

  • 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.
  • Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
  • 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.
  • Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
  • Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
Show all 9Show fewer
  • 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.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
  • Further exclusion criteria apply.

Trial locations and contacts

118 sites in 14 countries.

118 sites in 14 countries

United States32 sites

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731

  • Velocity Clinical Research - Binghamton

    Binghamton, New York, 13905

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Alliance for Multispecialty Research, LLC - Doral

    Doral, Florida, 33172

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104

  • University of Florida

    Gainesville, Florida, 32610

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • East-West Medical Research

    Honolulu, Hawaii, 96814

  • Juno Research, LLC

    Houston, Texas, 77040

  • East Coast Institute for Research, LLC - Jacksonville

    Jacksonville, Florida, 32216

  • AMR Lexington

    Lexington, Kentucky, 40509

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • New Horizon Research Center-Miami-69732

    Miami, Florida, 33165

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • EmVenio Research-Oklahoma City-70053

    Oklahoma City, Oklahoma, 73139

  • EmVenio Research-Phoenix-69743

    Phoenix, Arizona, 85032

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Velocity Clinical Research-Sioux City-69728

    Sioux City, Iowa, 51106

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077

  • Encompass Clinical Research, Spring Valley

    Spring Valley, California, 91978

  • Premier Research, Inc.

    Trenton, New Jersey, 08611

  • Velocity Clinical Research-Valparaiso-68883

    Valparaiso, Indiana, 46383

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • Southgate Medical Group/ Southgate Medical Park

    West Seneca, New York, 14224

  • Accellacare-Wilmington-67123

    Wilmington, North Carolina, 28401

Other trials in United States

China19 sites

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Pinggu Hospital

    Beijing, 101200

  • The First Hospital of Jilin University

    Changchun, 130021

  • Changzhou Second People's Hospital

    Changzhou, 213004

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599

  • Huzhou Central Hospital

    Huzhou, 313000

  • Center Hospital of Jinan

    Jinan, 250013

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011

  • Pingxiang People's Hospital

    Pingxiang, 337000

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, 200071

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240

  • Siping Central People's Hospital

    Siping, 136000

  • Suzhou Municipal Hospital

    Suzhou, 215002

  • Tianjin Medical University General Hospital

    Tianjin, 30052

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, 100029

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212013

Other trials in China

Canada10 sites

  • Aggarwal and Associates Ltd.

    Brampton, Ontario, L6T 0G1

  • ViaCar Recherches Cliniques Inc. (Greenfield Park)

    Greenfield Park, Quebec, J4V 2G8

  • The Wharton Medical Clinic Clinical Trials Inc.

    Hamilton, Ontario, L8L 5G8

  • Milestone Research Inc.

    London, Ontario, N5W 6A2

  • Power Clinical Research

    Montreal, Quebec, H3M 1L3

  • James Cha, MD

    Oshawa, Ontario, L1J 2K1

  • Stouffville Medical Research Institute Inc.

    Stouffville, Ontario, L4A 1H2

  • Albion Finch Medical Centre

    Toronto, Ontario, M9V 4B4

  • Dr. James Lai

    Vancouver, British Columbia, V5Z 4E1

  • Sameh Fikry Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

South Korea10 sites

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon-si, 14647

  • Kyungpook National University Hospital

    Daegu, 41944

  • Dongguk University Ilsan Hospital

    Goyang, 10326

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • The Catholic University of Korea, Yeouido St.Mary's Hospital

    Seoul, 07345

  • Kangbuk Samsung Hospital

    Seoul, 110-746

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Australia7 sites

  • Monash University

    Box Hill, Victoria, 3128

  • Austin Health

    Heidelberg, Victoria, 3084

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • CORE Research Group

    Milton, Queensland, 4064

  • Keogh Institute for Medical Research

    Nedlands, Western Australia, 6009

  • Griffith Health

    Southport, Queensland, 4125

Other trials in Australia

United Kingdom6 sites

  • Waterloo Medical Centre

    Blackpool, FY4 3AD

  • Bradford on Avon Health Centre

    Bradford on Avon, BA15 1DQ

  • Burbage Surgery

    Burbage, Hinkley, LE10 2SE

  • Kiltearn Medical Centre

    Nantwich, CW5 5NX

  • Clifton Medical Centre, Rotherham

    Rotherham, S65 1DA

  • Trowbridge Health Centre

    Trowbridge, BA14 8LW

Other trials in United Kingdom

Japan5 sites

  • Fukuhama Chuo Clinic

    Fukuoka, Fukuoka, 810-0066

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017

  • Noritake Clinic

    Ibaraki, Ushiku, 300-1207

  • Soka Sugiura Naika Clinic

    Saitama, Soka, 340-0034

  • Hachioji Diabetes Clinic

    Tokyo, Hachioji, 192-0083

Other trials in Japan

New Zealand5 sites

  • P3 Research Dunedin

    Dunedin, 9016

  • Southern Clinical Trials Tasman

    Nelson, 7011

  • P3 Research-Newtown Wellington NZ-33770

    Newtown Wellington NZ, 6021

  • Optimal Clinical Trials North

    Rosedale, Auckland, 0632

  • P3 Research-Tauranga-34833

    Tauranga, 3110

Other trials in New Zealand

Poland5 sites

  • PI HOUSE Sp. z o.o., Gdansk

    Gdansk, 80-546

  • ETG Lublin

    Lublin, 20-412

  • Velocity Nova Sp z o.o.

    Puławy, 24-100

  • ETG Siedlce

    Siedlce, 08-110

  • Clinical Research Center METABOLICA lek. Robert Witek

    Tarnów, 33-100

Other trials in Poland

Belgium4 sites

  • ASZ - Campus Aalst

    Aalst, 9300

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800

Other trials in Belgium

Finland4 sites

  • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

    Helsinki, 00290

  • StudyCor Oy

    Jyväskylä, 40620

  • Itä-Suomen yliopisto/Health Step Finland Oy

    Kuopio, 70600

  • CRST - Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

Germany4 sites

  • InnoDiab Forschung GmbH

    Essen, 45136

  • MVZ im Altstadt-Caree Fulda GmbH

    Fulda, 36037

  • Diabetes Zentrum Hamburg West

    Hamburg, 22607

  • Institut für Diabetesforschung Münster GmbH

    Münster, 48145

Other trials in Germany

Sweden4 sites

  • Ladulaas Kliniska Studier

    Borås, 506 30

  • Forskningsenheten Carlanderska

    Gothenburg, 40545

  • Medicinmottagning 5/Överviktsenheten

    Örebro, 70362

  • Sabbatsbergs sjukhus

    Stockholm, 113 61

Other trials in Sweden

Netherlands3 sites

  • PT & R

    Born, 6121 XK

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 EZ

  • Franciscus Gasthuis

    Rotterdam, 3045 PM

Other trials in Netherlands

About this study

Official 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 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.
Read more

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.

Conditions
Obesity
Being tested
survodutide, Placebo
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • survodutideCombination product

    Also called BI 456906

    once weekly subcutaneous injection

  • PlaceboCombination product

    once weekly subcutaneous injection

Study groups in NCT06066515
Study groupRoleWhat they receive
Survodutide 3.6 mgExperimentalNot described
Receives: Combination Product: survodutide
Survodutide 6.0 mgExperimentalNot described
Receives: Combination Product: survodutide
PlaceboPlacebo comparatorNot described
Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in body weight from baseline to Week 76

    Measured: Baseline and at Week 76

  2. Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

    Measured: Baseline and at Week 76

Secondary outcomes (31)

  1. Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76

    Measured: Baseline and at Week 76

  2. Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76

    Measured: Baseline and at Week 76

  3. Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76

    Measured: Baseline and at Week 76

  4. Absolute change from baseline to Week 76 in body weight (kg)

    Measured: Baseline and Week 76

  5. Absolute change from baseline to Week 76 in waist circumference (cm)

    Measured: Baseline and at Week 76

  6. Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)

    Measured: Baseline and at Week 76

  7. 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.

    Measured: Baseline and at Week 76

  8. 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).

    Measured: Baseline and at Week 76

  9. Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)

    Measured: Baseline and at Week 76

  10. Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)

    Measured: Baseline and at Week 76

  11. Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)

    Measured: Baseline and at Week 76

  12. Absolute change from baseline to Week 76 in HbA1c (mmol/mol)

    Measured: Baseline and at Week 76

  13. Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)

    Measured: Baseline and at Week 76

  14. Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)

    Measured: Baseline and at Week 76

  15. Absolute change from baseline to Week 76 in total cholesterol (mg/dL)

    Measured: Baseline and at Week 76

  16. Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL)

    Measured: Baseline and at Week 76

  17. Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)

    Measured: Baseline and at Week 76

  18. Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL)

    Measured: Baseline and at Week 76

  19. Absolute change from baseline to Week 76 in triglycerides (mg/dL)

    Measured: Baseline and at Week 76

  20. Absolute change from baseline to Week 76 in free fatty acids (mg/dL)

    Measured: Baseline and at Week 76

  21. Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)

    Measured: Baseline and at Week 76

  22. Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)

    Measured: Baseline and at Week 76

  23. Absolute change from baseline to Week 76 in total fat volume (L)

    Measured: Baseline and at Week 76

  24. Absolute change from baseline to Week 76 in lean body volume (L)

    Measured: Baseline and at Week 76

  25. Absolute change from baseline to Week 76 in visceral fat volume (L)

    Measured: Baseline and at Week 76

  26. Absolute change from baseline to Week 76 in subcutaneous fat volume (L)

    Measured: Baseline and at Week 76.

  27. Relative change from baseline to Week 76 in total fat volume (%)

    Measured: Baseline and at Week 76

  28. Relative change from baseline to Week 76 in lean body volume (%)

    Measured: Baseline and at Week 76

  29. Relative change from baseline to Week 76 in visceral fat volume (%)

    Measured: Baseline and at Week 76

  30. Relative change from baseline to Week 76 in subcutaneous fat volume (%)

    Measured: Baseline and at Week 76.

  31. Relative change from baseline to Week 76 in liver fat content (%)

    Measured: Baseline and at Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start25 Nov 2023
  3. Primary completion2 Dec 2025
  4. Study completion20 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
726 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06066515
Sponsor's protocol ID
1404-0038
Other IDs
U1111-1288-9400, 2022-502529-17-00
Acronym
SYNCHRONIZE™-1
Status last verified
Mar 2026
First submitted
27 Sep 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 42253238

  • 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.

    PubMed 41187967

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing survodutide in people with Obesity, run by Boehringer Ingelheim at 118 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, China, Canada, South Korea, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in body weight from baseline to Week 76 (time frame: Baseline and at Week 76). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06066515, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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