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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06066528
Other study ID # 1404-0041
Secondary ID 2022-502531-18-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 15, 2023
Est. completion date January 16, 2026

Study information

Verified date June 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date January 16, 2026
Est. primary completion date December 19, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 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. 6. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply. Exclusion Criteria: 1. Body weight change (self-reported) of >5% within 3 months before screening. 2. Treatment with any medication for the indication obesity within 3 months before screening. 3. 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). 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). Further exclusion criteria apply.

Study Design


Intervention

Drug:
Survodutide
once weekly subcutaneous injection
Placebo
once weekly subcutaneous injection

Locations

Country Name City State
Australia Monash University Box Hill Victoria
Australia Austin Health Heidelberg Victoria
Australia Nepean Hospital Kingswood New South Wales
Australia Baker Heart and Diabetes Institute Melbourne Victoria
Australia Hunter Diabetes Centre Merewether New South Wales
Australia CORE Research Group Milton Queensland
Australia Keogh Institute for Medical Research Nedlands Western Australia
Australia Griffith Health Southport Queensland
Belgium ASZ - Campus Aalst Aalst
Belgium Brussels - UNIV UZ Brussel Jette
Belgium UZ Leuven Leuven
Belgium Roeselare - HOSP AZ Delta Roeselare
Canada Aggarwal and Associates Ltd. Brampton Ontario
Canada Centricity Research (Calgary) Calgary Alberta
Canada The Wharton Medical Clinic Clinical Trials Inc. Hamilton Ontario
Canada Milestone Research Inc. London Ontario
Canada Power Clinical Research Montreal Quebec
Canada Recherche GCP Research Montreal Quebec
Canada James Cha, MD Oshawa Ontario
Canada Stouffville Medical Centre Stouffville Ontario
Canada Albion Finch Medical Centre Toronto Ontario
Canada Dr. James Lai Vancouver British Columbia
Canada Sameh Fikry Medicine Professional Corporation Waterloo Ontario
China Beijing Pinggu Hospital Beijing
China Peking University People's 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 The Second Affiliated Hospital of Nanjing Medical University Hangzhou
China Forth Clinical Hospital of Harbin Medical University Harbin
China 2nd Hospital Affiliated to Zhengzhou University Henan Province
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 Pingxiang People's Hospital Pingxiang
China Shanghai Fifth People's Hospital affiliated to Fudan University Shanghai
China Shanghai Municipal Hospital of Traditional Chinese Medicine 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 Affiliated Hospital of Jiangsu University Zhenjiang
Czechia 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
Denmark Sanos Clinic Gandrup (SMO) Gandrup
Finland HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki Helsinki
Finland Itä-Suomen yliopisto/Health Step Finland Oy Kuopio
Finland CRST - Clinical Research Services Turku Turku
Germany 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 RED Institut GmbH Oldenburg
Germany Forschungszentrum Ruhr, KliFo Center GmbH Witten
Greece Athens Medical Center Athens
Greece Thermi Clinic Thermi
Greece Euromedica General Clinic of Thessaloniki Thessaloniki
Hungary DRC Drug Research Ltd Balatonfured
Hungary Belinus Bt Debrecen
Hungary CRU Hungary Ltd. Kistarcsa
Hungary Arina Trial Research kft. Oroshaza
Hungary University of Szeged Szeged
Japan 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
Korea, Republic of 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 Kangbuk Samsung Hospital Seoul
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 Ajou University Hospital Suwon
Netherlands PT & R Born
Netherlands Universitair Medisch Centrum Groningen Groningen
New Zealand P3 Research Dunedin Dunedin
New Zealand Southern Clinical Trials Tasman Nelson
New Zealand P3 Research Newtown Wellington NZ
New Zealand Optimal Clinical Trials North Rosedale, Auckland
New Zealand P3 Research Tauranga
Poland 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
Spain Hospital A Coruña A Coruña
Spain Hospital Vithas Sevilla Castilleja de la Cuesta
Spain Hospital Arnau de Vilanova Lleida
Spain Clínica Universidad de Navarra - Madrid Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Clínica Universidad de Navarra Pamplona
Spain Hospital de Canarias San Cristóbal de La Laguna
Sweden Ladulaas Kliniska Studier Borås
Sweden Forskningsenheten Carlanderska Göteborg
Sweden Pharmasite Malmo Malmö
Sweden Medicinmottagning 5/Överviktsenheten Örebro
Sweden Sabbatsbergs sjukhus Stockhom
United Kingdom Waterloo Medical Centre Blackpool
United Kingdom Bradford on Avon Health Centre Bradford on Avon
United Kingdom Mounts Bay Medical Ltd Hayle
United Kingdom Clifton Medical Centre, Rotherham Rotherham
United Kingdom Trowbridge Health Centre Trowbridge
United States Pinnacle Research Group, LLC Anniston Alabama
United States Emory University Atlanta Georgia
United States Walgreens Clinical Trials Atlantic City New Jersey
United States Texas Diabetes and Endocrinology Austin Texas
United States Alliance for Multispecialty Research Coral Gables Florida
United States Valley Weight Loss Clinic Fargo North Dakota
United States University of Florida Gainesville Florida
United States Physicians East, PA Greenville North Carolina
United States East-West Medical Research Honolulu Hawaii
United States Juno Research, LLC Houston Texas
United States East Coast Institute for Research, LLC Jacksonville Florida
United States AMR Lexington Lexington Kentucky
United States L-MARC Research Center Louisville Kentucky
United States Manassas Clinical Research Center Manassas Virginia
United States Solaris Clinical Research Meridian Idaho
United States New Horizon Research Center Miami Florida
United States Lucas Research, Inc. Morehead City North Carolina
United States Trial Management Associates Myrtle Beach South Carolina
United States West Orange Endocrinology Ocoee Florida
United States EmVenio Research Oklahoma City Oklahoma
United States Walgreens Clinical Trials Perth Amboy New Jersey
United States EmVenio Research Phoenix Arizona
United States Rainier Clinical Research Center Renton Washington
United States StudyMetrix Research, LLC Saint Peters Missouri
United States Diabetes & Glandular Disease Clinic, P.A. San Antonio Texas
United States Consano Clinical Research Shavano Park Texas
United States Velocity Clinical Research Sioux City Iowa
United States Evanston Premier Healthcare Research LLC Skokie Illinois
United States Encompass Clinical Research, Spring Valley Spring Valley California
United States Premier Research, Inc. Trenton New Jersey
United States Velocity Clinical Research Valparaiso Indiana
United States Velocity Clinical Research, Vestal Vestal New York
United States Diablo Clinical Research Walnut Creek California
United States Southgate Medical Group/ Southgate Medical Park West Seneca New York
United States Accellacare Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Hungary,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change in body weight from baseline to Week 76 Baseline and at Week 76
Primary Achievement of body weight reduction =5% (yes/no) from baseline to Week 76 Baseline and at Week 76
Secondary Achievement of body weight reduction =10% (yes/no) from baseline to Week 76 Baseline and at Week 76
Secondary Achievement of body weight reduction =15% (yes/no) from baseline to Week 76 Baseline and at Week 76
Secondary Achievement of body weight reduction =20% (yes/no) from baseline to Week 76 Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in body weight (kg) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in waist circumference (cm) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg) Baseline and at Week 76
Secondary 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. Baseline and at Week 76
Secondary 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). Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in HbA1c (mmol/mol) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in total cholesterol (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in triglycerides (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in free fatty acids (mg/dL) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L) Baseline and at Week 76
Secondary Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L) Baseline and at Week 76
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