NCT06066515CompletedPhase 3
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, 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
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 726 (actual)
- First submitted
- 27 Sept 2023
- Start date
- 25 Nov 2023
- Primary completion date
- 2 Dec 2025
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06066515
- EU CT number
- 2022-502529-17-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 726
- From 25 Nov 2023 to the primary completion date, 2 Dec 2025
- 123 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
- Further exclusion criteria apply.
Lab values
- 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.
- 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.
Other
- Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (123)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash University Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Baker Heart and Diabetes Institute Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Hunter Diabetes Centre Coordinator of this site? Confirm its status | Merewether | Australia | Unknown status |
| Core Research Group Coordinator of this site? Confirm its status | Milton | Australia | Unknown status |
| Keogh Institute for Medical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Griffith Health Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Algemeen Stedelijk Ziekenhuis - campus Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Completed |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Completed |
| Aggarwal and Associates Ltd Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| ViaCar Recherches Cliniques Inc. (Greenfield Park) Coordinator of this site? Confirm its status | Greenfield Park | Canada | Unknown status |
| The Wharton Medical Clinic Clinical Trials Inc Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Milestone Research Inc. Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Power Clinical Research Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| James Cha, MD Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Stouffville Medical Research Institute Inc. Coordinator of this site? Confirm its status | Stouffville | Canada | Unknown status |
| Albion Finch Medical Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Dr. James Lai Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Sameh Fikry Medicine Professional Corporation Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Beijing Pinggu Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Changzhou Second People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Forth Clinical Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Center Hospital of Jinan Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Shanghai Fifth People's Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Municipal Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Siping Central People's Hospital Coordinator of this site? Confirm its status | Siping | China | Unknown status |
| Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Xi'an Medical University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| MVZ im Altstadt-Carree Fulda GmbH Coordinator of this site? Confirm its status | Fulda | Germany | Completed |
| Diabetes Zentrum Hamburg West Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Completed |
| KliFoCenter GmbH Coordinator of this site? Confirm its status | Witten | Germany | Completed |
| HUS Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Studycor Oy Coordinator of this site? Confirm its status | Jyväskylä | Finland | Completed |
| Health Step Finland Oy Coordinator of this site? Confirm its status | Kuopio | Finland | Completed |
| Clinical Research Services Turku Oy Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Waterloo Medical Centre Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| Bradford on Avon Health Centre Coordinator of this site? Confirm its status | Bradford on Avon | United Kingdom | Unknown status |
| Burbage Surgery Coordinator of this site? Confirm its status | Burbage, Hinkley | United Kingdom | Unknown status |
| Kiltearn Medical Centre Coordinator of this site? Confirm its status | Nantwich | United Kingdom | Unknown status |
| Clifton Medical Centre, Rotherham Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Unknown status |
| Trowbridge Health Centre Coordinator of this site? Confirm its status | Trowbridge | United Kingdom | Unknown status |
| Fukuhama Chuo Clinic Coordinator of this site? Confirm its status | Fukuoka, Fukuoka | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Hyogo, Kobe | Japan | Unknown status |
| Noritake Clinic Coordinator of this site? Confirm its status | Ibaraki, Ushiku | Japan | Unknown status |
| Soka Sugiura Naika Clinic Coordinator of this site? Confirm its status | Saitama, Soka | Japan | Unknown status |
| Hachioji Diabetes Clinic Coordinator of this site? Confirm its status | Tokyo, Hachioji | Japan | Unknown status |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Dongguk University Ilsan Hospital Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| The Catholic University of Korea Yeouido St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| PreCare Trial & Recruitment B.V. Coordinator of this site? Confirm its status | Born | Netherlands | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Stichting Treant Ziekenhuiszorg Coordinator of this site? Confirm its status | Hoogeveen | Netherlands | Completed |
| Sint Franciscus Vlietland Groep Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| P3 Research Dunedin Coordinator of this site? Confirm its status | Dunedin | New Zealand | Unknown status |
| Southern Clinical Trials Tasman Coordinator of this site? Confirm its status | Nelson | New Zealand | Unknown status |
| P3 Research-Newtown Wellington NZ-33770 Coordinator of this site? Confirm its status | Newtown Wellington NZ | New Zealand | Unknown status |
| Optimal Clinical Trials North Coordinator of this site? Confirm its status | Rosedale, Auckland | New Zealand | Unknown status |
| P3 Research-Tauranga-34833 Coordinator of this site? Confirm its status | Tauranga | New Zealand | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Centrum Medyczne Kuba-Med 2 Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Pulawy | Poland | Completed |
| Lukmed 2 Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Completed |
| Metabolica Sp. z o.o. Coordinator of this site? Confirm its status | Tarnów | Poland | Completed |
| Ladulaas AB Coordinator of this site? Confirm its status | Boras | Sweden | Completed |
| Stift Carlanderska Sjukhuset Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| PharmaSite AB Coordinator of this site? Confirm its status | Malmo | Sweden | Completed |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Completed |
| Region Stockholm – SLSO Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| Texas Diabetes and Endocrinology Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Velocity Clinical Research - Binghamton Coordinator of this site? Confirm its status | Binghamton | United States | Unknown status |
| StudyMetrix Research, LLC Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Alliance for Multispecialty Research, LLC - Doral Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| Valley Weight Loss Clinic Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Physicians East, PA Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| East-West Medical Research Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Juno Research, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| East Coast Institute for Research, LLC - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| AMR Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| L-MARC Research Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Solaris Clinical Research Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| New Horizon Research Center-Miami-69732 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Trial Management Associates Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| West Orange Endocrinology Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| EmVenio Research-Oklahoma City-70053 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| EmVenio Research-Phoenix-69743 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Rainier Clinical Research Center Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Diabetes & Glandular Disease Clinic, P.A. Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Consano Clinical Research Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Velocity Clinical Research-Sioux City-69728 Coordinator of this site? Confirm its status | Sioux City | United States | Unknown status |
| Evanston Premier Healthcare Research, LLC Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Encompass Clinical Research_Spring Valley Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| Premier Research Inc. Coordinator of this site? Confirm its status | Trenton | United States | Unknown status |
| Velocity Clinical Research-Valparaiso-68883 Coordinator of this site? Confirm its status | Valparaiso | United States | Unknown status |
| Diablo Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Southgate Medical Group/ Southgate Medical Park Coordinator of this site? Confirm its status | West Seneca | United States | Unknown status |
| Accellacare-Wilmington-67123 Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
Related publications
- Survodutide Once Weekly for the Treatment of Adults with Obesity.N Engl J Med · 2026 · PMID 42253238
- 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 · PMID 41187967
This page is information, not medical advice. Discuss any trial with your doctor.