ObesityPhase 3SYNCHRONIZE™-2NCT06066528
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
A Phase 3 study testing Survodutide in people with Obesity and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 143 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- 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
- 755 participants
- Where
- 143 sitesin 19 countries
- Study dates
- 27 Nov 2023to 1 Apr 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) ≥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.
- 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.
- 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).
- 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).
- Further exclusion criteria apply.
Trial locations and contacts
143 sites in 19 countries.
143 sites in 19 countries
United States34 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Emory University
Atlanta, Georgia, 30303
Walgreens Clinical Trials-Atlantic City-69647
Atlantic City, New Jersey, 08401
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
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
West Orange Endocrinology
Ocoee, Florida, 34761
EmVenio Research-Oklahoma City-70053
Oklahoma City, Oklahoma, 73139
Walgreens - Perth Amboy - Site 4544
Perth Amboy, New Jersey, 08861
EmVenio Research-Atlanta-69582
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
China20 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
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
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
Canada11 sites
Aggarwal and Associates Ltd.
Brampton, Ontario, L6T 0G1
Centricity Research (Calgary)
Calgary, Alberta, T2H 2G4
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario, L8L 5G8
Milestone Research Inc.
London, Ontario, N5W 6A2
Recherche GCP Research
Montreal, Quebec, H1Y 3H5
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
South Korea9 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
Ajou University Hospital
Suwon, 16499
Australia8 sites
Monash University
Box Hill, Victoria, 3128
Austin Health
Heidelberg, Victoria, 3084
Nepean Hospital
Kingswood, New South Wales, 2747
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
Spain7 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950
Hospital Arnau de Vilanova
Lleida, 25198
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Clínica Universidad de Navarra - Madrid
Madrid, 28027
Clínica Universidad de Navarra
Pamplona, 31008
Hospital de Canarias
San Cristóbal de La Laguna, 38320
Germany6 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
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Oldenburg in Holstein, 23758
Forschungszentrum Ruhr, KliFo Center GmbH
Witten, 58455
Japan6 sites
Fukuhama Chuo Clinic
Fukuoka, Fukuoka, 810-0066
Itabashi Diabetic medicine and Dermatology Clinic
Ibaraki, Koga, 306-0232
Nagase Clinic
Ibaraki, Ushiku, 300-1207
Soka Sugiura Naika Clinic
Saitama, Soka, 340-0034
Oyama East Clinic
Tochigi, Oyama, 323-0022
Hachioji Diabetes Clinic
Tokyo, Hachioji, 192-0083
Czechia5 sites
Edumed s.r.o
Broumov, 55001
NZZ Agentura Science Pro s.r.o., Olomouc
Olomouc, 772 00
Dieko, s.r.o.
Pilsen, 301 00
Polyclinic Michnova Ltd.
Prague, 149 00
Private Practice - Dr. Barbora Diepoltova
Prague, 190 14
Hungary5 sites
DRC Drug Research Ltd-Balatonfured-59734
Balatonfüred, 8230
Belinus Bt
Debrecen, 4025
CRU Hungary Ltd.
Kistarcsa, 2143
Arina Trial Research kft.
Orosháza, 5900
University of Szeged
Szeged, 6725
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
Poland5 sites
PI HOUSE Sp. z o.o., Gdansk
Gdansk, 80546
ETG Lublin
Lublin, 20-412
Velocity Nova Sp z o.o.
Puławy, 24-100
ETG Siedlce
Siedlce, 08-110
METABOLICA Sp.zo.o. NZOZ METABOLICA Osrodek badan klinicznych
Tarnów, 33-100
Sweden5 sites
Ladulaas Kliniska Studier
Borås, 506 30
Forskningsenheten Carlanderska
Gothenburg, 40545
Pharmasite Malmo
Malmö, 211 52
Medicinmottagning 5/Överviktsenheten
Örebro, 70362
Sabbatsbergs sjukhus
Stockholm, 113 61
United Kingdom5 sites
Waterloo Medical Centre
Blackpool, FY4 3AD
Bradford on Avon Health Centre
Bradford on Avon, BA15 1DQ
Mounts Bay Medical Limited
Hayle, TR27 5DT
Clifton Medical Centre, Rotherham
Rotherham, S65 1DA
Trowbridge Health Centre
Trowbridge, BA14 8LW
Belgium3 sites
ASZ - Campus Aalst
Aalst, 9300
UZ Leuven
Leuven, 3000
AZ Delta
Roeselare, 8800
Finland3 sites
HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
Helsinki, 00290
Itä-Suomen yliopisto/Health Step Finland Oy
Kuopio, 70600
CRST - Clinical Research Services Turku
Turku, 20520
Greece3 sites
Athens Medical Center
Athens, 15125
Thermi Clinic
Thermi, 57001
Nexthealth S.A
Thessaloniki, 54645
Netherlands2 sites
PT & R
Born, 6121 XK
Universitair Medisch Centrum Groningen
Groningen, 9713 EZ
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 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.
Read more
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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Survodutide, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
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, pre-filled syringe
PlaceboCombination product
once weekly subcutaneous injection, pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| Survodutide 3.6 mg | Experimental | Not described Receives: Combination Product: Survodutide |
| Survodutide 6.0 mg | Experimental | Not described Receives: Combination Product: Survodutide |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline to Week 76
Measured: Baseline and at Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Measured: Baseline and at Week 76
Secondary outcomes (22)
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Measured: Baseline and at Week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Measured: Baseline and at Week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in body weight (kg)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in waist circumference (cm)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Measured: 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.
Measured: 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).
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Measured: Baseline and at Week 76
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
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.
- First posted4 Oct 2023
- Study start27 Nov 2023
- Primary completion12 Dec 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066528
- Sponsor's protocol ID
- 1404-0041
- Other IDs
- 2022-502531-18-00, U1111-1289-0247
- Acronym
- SYNCHRONIZE™-2
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2023
- Last updated
- 6 Aug 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.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.
Publications
Wharton S, le Roux CW, Startseva E, Kloer IM, Alhussein A, Hussain SA, Unseld A, Bozkurt B, Ard JD, Bays HE, Bogdanski P, Butt JH, Ekinci EI, Jastreboff AM, Ji L, Schou M, Tinahones FJ, Kokkinos AD, Merkely B, Ogawa W, Pedersen SD, Pietilainen KH, Quinn D, Sattar N, Seufert J, Stenlof K, van Beek AP, Vangoitsenhoven R, Brueckmann M, Younes R, Kaplan LM; SYNCHRONIZE-2 Investigators. Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes. N Engl J Med. 2026 Oct 1. doi: 10.1056/NEJMoa2607219. Online ahead of print.
PubMed 42820639Wharton 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.
PubMed 41216778
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06066528
- Acronym / sponsor ID
- SYNCHRONIZE™-2 / 1404-0041
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Survodutide 3.6 mg | Experimental | Combination Product: Survodutide |
| Survodutide 6.0 mg | Experimental | Combination Product: Survodutide |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurvodutideAlso: BI 456906once weekly subcutaneous injection, pre-filled syringe | Combination product | Survodutide 3.6 mg, Survodutide 6.0 mg |
| Placeboonce weekly subcutaneous injection, pre-filled syringe | Combination product | Placebo |
Primary outcome
Percentage change in body weight from baseline to Week 76
Time frame: 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
22 secondary outcomes
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Time frame: 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
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Time frame: Baseline and at Week 76
Absolute change from baseline to Week 76 in body weight (kg)
Time frame: Baseline and at Week 76
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Time frame: Baseline and at Week 76
Absolute change from baseline to Week 76 in waist circumference (cm)
Time frame: 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
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)
Time frame: Baseline and at Week 76
Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Time frame: 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
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Time frame: 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
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Time frame: 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
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Time frame: 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
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)
Time frame: 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
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Time frame: 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
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 42820639Wharton S, le Roux CW, Startseva E, Kloer IM, Alhussein A, Hussain SA, Unseld A, Bozkurt B, Ard JD, Bays HE, Bogdanski P, Butt JH, Ekinci EI, Jastreboff AM, Ji L, Schou M, Tinahones FJ, Kokkinos AD, Merkely B, Ogawa W, Pedersen SD, Pietilainen KH, Quinn D, Sattar N, Seufert J, Stenlof K, van Beek AP, Vangoitsenhoven R, Brueckmann M, Younes R, Kaplan LM; SYNCHRONIZE-2 Investigators. Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes. N Engl J Med. 2026 Oct 1. doi: 10.1056/NEJMoa2607219. Online ahead of print.
- Derived from this study: PubMed 41216778Wharton 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obesity
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
143 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Survodutide in people with Obesity and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 143 sites in 19 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 6 inclusion and 7 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 143 sites in United States, China, Canada, South Korea, Australia and 14 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 NCT06066528, 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 6 Aug 2026.