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A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Sponsor: Boehringer Ingelheim
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. 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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
755
Start Date
2023-11-27
Completion Date
2026-04-01
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
Survodutide
once weekly subcutaneous injection, pre-filled syringe
Placebo
once weekly subcutaneous injection, pre-filled syringe
Locations (143)
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
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
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 Research Institute Inc.
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
Union Hospital Tongji Medical College Huazhong University of Science and Technology
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
Broumov, 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