A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
NCT ID: NCT06066528
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
755 participants
INTERVENTIONAL
2023-11-27
2026-04-03
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Survodutide 3.6 mg
Survodutide
once weekly subcutaneous injection
Survodutide 6.0 mg
Survodutide
once weekly subcutaneous injection
Placebo
Placebo
once weekly subcutaneous injection
Interventions
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Survodutide
once weekly subcutaneous injection
Placebo
once weekly subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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).
Exclusion Criteria
2. Treatment with any medication for the indication obesity within 3 months before screening.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
EmVenio Research-Atlanta-69582
Phoenix, Arizona, United States
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC - Doral
Doral, Florida, United States
University of Florida
Gainesville, Florida, United States
East Coast Institute for Research, LLC-Jacksonville-55146
Jacksonville, Florida, United States
New Horizon Research Center-Miami-69732
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Emory University
Atlanta, Georgia, United States
East-West Medical Research
Honolulu, Hawaii, United States
Solaris Clinical Research
Meridian, Idaho, United States
Evanston Premier Healthcare Research LLC
Skokie, Illinois, United States
Velocity Clinical Research-Valparaiso-68883
Valparaiso, Indiana, United States
Velocity Clinical Research-Sioux City-69728
Sioux City, Iowa, United States
AMR Lexington
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Walgreens Clinical Trials-Atlantic City-69647
Atlantic City, New Jersey, United States
Walgreens - Perth Amboy - Site 4544
Perth Amboy, New Jersey, United States
Premier Research, Inc.
Trenton, New Jersey, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, United States
Southgate Medical Group/ Southgate Medical Park
West Seneca, New York, United States
Physicians East, PA
Greenville, North Carolina, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
Accellacare-Wilmington-67123
Wilmington, North Carolina, United States
EmVenio Research-Oklahoma City-70053
Oklahoma City, Oklahoma, United States
Trial Management Associates
Myrtle Beach, South Carolina, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Nepean Hospital
Kingswood, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
CORE Research Group
Milton, Queensland, Australia
Griffith Health
Southport, Queensland, Australia
Monash University
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Keogh Institute for Medical Research
Nedlands, Western Australia, Australia
ASZ - Campus Aalst
Aalst, , Belgium
UZ Leuven
Leuven, , Belgium
Roeselare - HOSP AZ Delta
Roeselare, , Belgium
Centricity Research (Calgary)
Calgary, Alberta, Canada
Dr. James Lai
Vancouver, British Columbia, Canada
Aggarwal and Associates Ltd.
Brampton, Ontario, Canada
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario, Canada
Milestone Research Inc.
London, Ontario, Canada
James Cha, MD
Oshawa, Ontario, Canada
Stouffville Medical Centre
Stouffville, Ontario, Canada
Albion Finch Medical Centre
Toronto, Ontario, Canada
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Power Clinical Research
Montreal, Quebec, Canada
Peking University People's Hospital
Beijing, , China
Beijing Pinggu Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Changzhou Second People's Hospital
Changzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Forth Clinical Hospital of Harbin Medical University
Harbin, , China
Huzhou Central Hospital
Huzhou, , China
Center Hospital of Jinan
Jinan, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, , China
Pingxiang People's Hospital
Pingxiang, , China
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, , China
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, , China
Siping Central People's Hospital
Siping, , China
Suzhou Municipal Hospital
Suzhou, , China
Tianjin Medical University General Hospital
Tianjin, , China
Wuhan Union Hospital
Wuhan, , China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, , China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
EDUMED s.r.o.
Náchod, , Czechia
NZZ Agentura Science Pro s.r.o., Olomouc
Olomouc, , Czechia
Dieko, s.r.o.
Pilsen, , Czechia
Polyclinic Michnova Ltd.
Prague, , Czechia
Private Practice - Dr. Barbora Diepoltova
Prague, , Czechia
Sanos Clinic Gandrup (SMO)
Gandrup, , Denmark
HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
Helsinki, , Finland
Itä-Suomen yliopisto/Health Step Finland Oy
Kuopio, , Finland
CRST - Clinical Research Services Turku
Turku, , Finland
InnoDiab Forschung GmbH
Essen, , Germany
MVZ im Altstadt-Caree Fulda GmbH
Fulda, , Germany
Diabetes Zentrum Hamburg West
Hamburg, , Germany
Institut für Diabetesforschung Münster GmbH
Münster, , Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Forschungszentrum Ruhr, KliFo Center GmbH
Witten, , Germany
Athens Medical Center
Athens, , Greece
Thermi Clinic
Thermi, , Greece
Nexthealth S.A
Thessaloniki, , Greece
DRC Drug Research Ltd-Balatonfured-59734
Balatonfüred, , Hungary
Belinus Bt
Debrecen, , Hungary
CRU Hungary Ltd.
Kistarcsa, , Hungary
Arina Trial Research kft.
Orosháza, , Hungary
University of Szeged
Szeged, , Hungary
Fukuhama Chuo Clinic
Fukuoka, Fukuoka, , Japan
Itabashi Diabetic medicine and Dermatology Clinic
Ibaraki, Koga, , Japan
Noritake Clinic
Ibaraki, Ushiku, , Japan
Soka Sugiura Naika Clinic
Saitama, Soka, , Japan
Oyama East Clinic
Tochigi, Oyama, , Japan
Hachioji Diabetes Clinic
Tokyo, Hachioji, , Japan
PT & R
Born, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
P3 Research Dunedin
Dunedin, , New Zealand
Southern Clinical Trials Tasman
Nelson, , New Zealand
P3 Research-Newtown Wellington NZ-33770
Newtown Wellington NZ, , New Zealand
Optimal Clinical Trials North
Rosedale, Auckland, , New Zealand
P3 Research-Tauranga-34833
Tauranga, , New Zealand
PI HOUSE Sp. z o.o., Gdansk
Gdansk, , Poland
ETG Lublin
Lublin, , Poland
Velocity Nova Sp z o.o.
Puławy, , Poland
ETG Siedlce
Siedlce, , Poland
Clinical Research Center METABOLICA lek. Robert Witek
Tarnów, , Poland
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Dongguk University Ilsan Hospital
Goyang, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Vithas Sevilla
Castilleja de la Cuesta, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Clínica Universidad de Navarra - Madrid
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital de Canarias
San Cristóbal de La Laguna, , Spain
Ladulaas Kliniska Studier
Borås, , Sweden
Forskningsenheten Carlanderska
Gothenburg, , Sweden
Pharmasite Malmo
Malmo, , Sweden
Medicinmottagning 5/Överviktsenheten
Örebro, , Sweden
Sabbatsbergs sjukhus
Stockholm, , Sweden
Waterloo Medical Centre
Blackpool, , United Kingdom
Bradford on Avon Health Centre
Bradford-on-Avon, , United Kingdom
Mounts Bay Medical Limited
Hayle, , United Kingdom
Clifton Medical Centre, Rotherham
Rotherham, , United Kingdom
Trowbridge Health Centre
Trowbridge, , United Kingdom
Countries
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References
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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. 2025 Nov 11. doi: 10.1111/dom.70263. Online ahead of print.
Related Links
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Related Info
Other Identifiers
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2022-502531-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1289-0247
Identifier Type: REGISTRY
Identifier Source: secondary_id
1404-0041
Identifier Type: -
Identifier Source: org_study_id