A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
- Conditions
- ObesityDiabetes Mellitus, Type 2
- Interventions
- Drug: Placebo
- Registration Number
- NCT06066528
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 756
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Survodutide 3.6 mg Survodutide - Placebo Placebo - Survodutide 6.0 mg Survodutide -
- Primary Outcome Measures
Name Time Method Percentage change in body weight from baseline to Week 76 Baseline and at Week 76 Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76 Baseline and at Week 76
- Secondary Outcome Measures
Name Time Method Absolute change from baseline to Week 76 in HbA1c (mmol/mol) Baseline and at Week 76 Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg) Baseline and at Week 76 Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L) Baseline and at Week 76 Absolute change from baseline to Week 76 in total cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in triglycerides (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in free fatty acids (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L) Baseline and at Week 76 Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L) Baseline and at Week 76 Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2) Baseline and at Week 76 Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76 Baseline and at Week 76 Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76 Baseline and at Week 76 Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76 Baseline and at Week 76 Absolute change from baseline to Week 76 in body weight (kg) Baseline and at Week 76 Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%) Baseline and at Week 76 Absolute change from baseline to Week 76 in waist circumference (cm) Baseline and at Week 76 Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg) 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) Baseline and at Week 76 "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.
Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score Baseline and at Week 76 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).
Trial Locations
- Locations (143)
Bradford on Avon Health Centre
🇬🇧Bradford on Avon, United Kingdom
Mounts Bay Medical Limited
🇬🇧Hayle, United Kingdom
Pingxiang People's Hospital
🇨🇳Pingxiang, China
EDUMED s.r.o.
🇨🇿Nachod, 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
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
PT & R
🇳🇱Born, Netherlands
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.
🇵🇱Pulawy, Poland
ETG Siedlce
🇵🇱Siedlce, Poland
Clinical Research Center METABOLICA lek. Robert Witek
🇵🇱Tarnow, Poland
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital Vithas Sevilla
🇪🇸Castilleja de la Cuesta, Spain
Hospital Arnau de Vilanova-Lleida-17625
🇪🇸Lleida, Spain
Pharmasite Malmo
🇸🇪Malmö, Sweden
Waterloo Medical Centre
🇬🇧Blackpool, United Kingdom
Sabbatsbergs sjukhus
🇸🇪Stockhom, Sweden
Medicinmottagning 5/Överviktsenheten
🇸🇪Örebro, Sweden
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
🇺🇸Saint Peters, Missouri, United States
Walgreens Clinical Trials-Atlantic City-69647
🇺🇸Atlantic City, New Jersey, United States
Walgreens Clinical Trials-Perth Amboy-69648
🇺🇸Perth Amboy, New Jersey, United States
Premier Research, Inc.
🇺🇸Trenton, New Jersey, United States
Velocity Clinical Research, Vestal
🇺🇸Vestal, 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
Soka Sugiura Naika Clinic
🇯🇵Saitama, Soka, Japan
Oyama East Clinic
🇯🇵Tochigi, Oyama, Japan
Hachioji Diabetes Clinic
🇯🇵Tokyo, Hachioji, Japan
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-Coral Gables-68872
🇺🇸Coral Gables, 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
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
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
Institut für Diabetesforschung Münster GmbH
🇩🇪Münster, Germany
RED Institut GmbH
🇩🇪Oldenburg, Germany
Forschungszentrum Ruhr, KliFo Center GmbH
🇩🇪Witten, Germany
Athens Medical Center
🇬🇷Athens, Greece
Thermi Clinic
🇬🇷Thermi, Greece
Euromedica General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
DRC Drug Research Ltd-Balatonfured-59734
🇭🇺Balatonfured, Hungary
Belinus Bt
🇭🇺Debrecen, Hungary
CRU Hungary Ltd.
🇭🇺Kistarcsa, Hungary
Arina Trial Research kft.
🇭🇺Oroshaza, 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
The Catholic University of Korea, Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Kyungpook National Univ. Hosp
🇰🇷Daegu, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
P3 Research Dunedin
🇳🇿Dunedin, New Zealand
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
🇸🇪Göteborg, Sweden
Clifton Medical Centre, Rotherham
🇬🇧Rotherham, United Kingdom
Trowbridge Health Centre
🇬🇧Trowbridge, United Kingdom