A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

Last updated: February 27, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Survodutide

BI 456906

Placebo

Clinical Study ID

NCT06066528
1404-0041
U1111-1289-0247
2022-502531-18-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, age ≥18 years at the time of signing informed consent, and at leastthe 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 haemoglobinA1c (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 centrallaboratory 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 bodyweight Further inclusion criteria apply.

Exclusion

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 beforescreening.

  3. Treatment with any medication for indication of T2DM other than stated in theinclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) anddipeptidyl peptidase 4 inhibitor [DPP-4il).

  4. Known clinically significant gastric emptying abnormality (e.g., severe diabeticgastroparesis or gastric outlet obstruction).

  5. History of either chronic or acute pancreatitis or elevation of serum lipase oramylase >2x upper limit of normal (ULN)) as measured by the central laboratory atscreening.

  6. Personal or family history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN 2).

Further exclusion criteria apply.

Study Design

Total Participants: 756
Treatment Group(s): 3
Primary Treatment: Survodutide
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
April 03, 2026

Connect with a study center

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • Hunter Diabetes Centre

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • CORE Research Group

    Milton, Queensland 4064
    Australia

    Site Not Available

  • Griffith Health

    Southport, Queensland 4125
    Australia

    Site Not Available

  • Monash University

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Keogh Institute for Medical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • ASZ - Campus Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • Brussels - UNIV UZ Brussel

    Jette, 1090
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Centricity Research (Calgary)

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • Dr. James Lai

    Vancouver, British Columbia V5Z 4E1
    Canada

    Site Not Available

  • Aggarwal and Associates Ltd.

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • The Wharton Medical Clinic Clinical Trials Inc.

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Milestone Research Inc.

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • James Cha, MD

    Oshawa, Ontario L1J 2K1
    Canada

    Site Not Available

  • Stouffville Medical Centre

    Stouffville, Ontario L4A 1H2
    Canada

    Site Not Available

  • Albion Finch Medical Centre

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • Sameh Fikry Medicine Professional Corporation

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Power Clinical Research

    Montreal, Quebec H3M 1L3
    Canada

    Site Not Available

  • Recherche GCP Research

    Montreal, Quebec H1Y 3H5
    Canada

    Site Not Available

  • Beijing Pinggu Hospital

    Beijing, 101200
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, 100044
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • Changzhou Second People's Hospital

    Changzhou, 213004
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Hangzhou, 210011
    China

    Site Not Available

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599
    China

    Site Not Available

  • 2nd Hospital Affiliated to Zhengzhou University

    Henan Province, 100029
    China

    Site Not Available

  • Huzhou Central Hospital

    Huzhou, 313000
    China

    Site Not Available

  • Center Hospital of Jinan

    Jinan, 250013
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, 337000
    China

    Site Not Available

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240
    China

    Site Not Available

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, 200071
    China

    Site Not Available

  • Siping Central People's Hospital

    Siping, 136000
    China

    Site Not Available

  • Suzhou Municipal Hospital

    Suzhou, 215002
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 30052
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, 100029
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212013
    China

    Site Not Available

  • EDUMED s.r.o.

    Nachod, 54701
    Czechia

    Site Not Available

  • NZZ Agentura Science Pro s.r.o., Olomouc

    Olomouc, 772 00
    Czechia

    Site Not Available

  • Dieko, s.r.o.

    Pilsen, 301 00
    Czechia

    Site Not Available

  • Polyclinic Michnova Ltd.

    Prague, 149 00
    Czechia

    Site Not Available

  • Private Practice - Dr. Barbora Diepoltova

    Prague, 190 14
    Czechia

    Site Not Available

  • Sanos Clinic Gandrup (SMO)

    Gandrup, 9362
    Denmark

    Site Not Available

  • Nordsjællands Hospital - Hillerød

    Hillerød, 3400
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre, 2650
    Denmark

    Site Not Available

  • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

    Helsinki, 00290
    Finland

    Site Not Available

  • Itä-Suomen yliopisto/Health Step Finland Oy

    Kuopio, 70210
    Finland

    Site Not Available

  • CRST - Clinical Research Services Turku

    Turku, 20520
    Finland

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

    Site Not Available

  • MVZ im Altstadt-Caree Fulda GmbH

    Fulda, 36037
    Germany

    Site Not Available

  • Diabetes Zentrum Hamburg West

    Hamburg, 22607
    Germany

    Site Not Available

  • Institut für Diabetesforschung Münster GmbH

    Münster, 48145
    Germany

    Site Not Available

  • RED Institut GmbH

    Oldenburg, 23758
    Germany

    Site Not Available

  • Forschungszentrum Ruhr, KliFo Center GmbH

    Witten, 58455
    Germany

    Site Not Available

  • Athens Medical Center

    Athens, 15125
    Greece

    Site Not Available

  • Thermi Clinic

    Thermi, 57001
    Greece

    Site Not Available

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645
    Greece

    Site Not Available

  • DRC Drug Research Ltd

    Balatonfured, 8230
    Hungary

    Site Not Available

  • DRC Drug Research Ltd-Balatonfured-59734

    Balatonfured, 8230
    Hungary

    Site Not Available

  • Belinus Bt

    Debrecen, 4025
    Hungary

    Site Not Available

  • CRU Hungary Ltd.

    Kistarcsa, 2143
    Hungary

    Site Not Available

  • Arina Trial Research kft.

    Oroshaza, 5900
    Hungary

    Site Not Available

  • University of Szeged

    Szeged, 6725
    Hungary

    Site Not Available

  • Fukuhama Chuo Clinic

    Fukuoka, Fukuoka, 810-0066
    Japan

    Site Not Available

  • Itabashi Diabetic medicine and Dermatology Clinic

    Ibaraki, Koga, 306-0232
    Japan

    Site Not Available

  • Noritake Clinic

    Ibaraki, Ushiku, 300-1207
    Japan

    Site Not Available

  • Soka Sugiura Naika Clinic

    Saitama, Soka, 340-0034
    Japan

    Site Not Available

  • Oyama East Clinic

    Tochigi, Oyama, 323-0022
    Japan

    Site Not Available

  • Hachioji Diabetes Clinic

    Tokyo, Hachioji, 192-0083
    Japan

    Site Not Available

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon, 14647
    Korea, Republic of

    Site Not Available

  • Kyungpook National Univ. Hosp

    Daegu, 700-721
    Korea, Republic of

    Site Not Available

  • Dongguk University Ilsan Hospital

    Goyang, 10326
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 110-746
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St.Mary's Hospital

    Seoul, 07345
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • PT & R

    Born, 6121 XK
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 EZ
    Netherlands

    Site Not Available

  • Bethesda Diabetes Research Center, Hoogeveen

    RA Hoogeveen, 7900
    Netherlands

    Site Not Available

  • P3 Research Dunedin

    Dunedin, 9016
    New Zealand

    Site Not Available

  • Southern Clinical Trials Tasman

    Nelson, 7011
    New Zealand

    Site Not Available

  • P3 Research

    Newtown Wellington NZ, 6021
    New Zealand

    Site Not Available

  • P3 Research-Newtown Wellington NZ-33770

    Newtown Wellington NZ, 6021
    New Zealand

    Site Not Available

  • Optimal Clinical Trials North

    Rosedale, Auckland, 0632
    New Zealand

    Site Not Available

  • P3 Research

    Tauranga, 3110
    New Zealand

    Site Not Available

  • P3 Research-Tauranga-34833

    Tauranga, 3110
    New Zealand

    Site Not Available

  • PI HOUSE Sp. z o.o., Gdansk

    Gdansk, 80546
    Poland

    Site Not Available

  • ETG Lublin

    Lublin, 20-412
    Poland

    Site Not Available

  • KOMED Marek Konieczny

    Pulawy, 24-100
    Poland

    Active - Recruiting

  • Velocity Nova Sp z o.o.

    Pulawy, 24-100
    Poland

    Site Not Available

  • ETG Siedlce

    Siedlce, 08-110
    Poland

    Site Not Available

  • Clinical Research Center METABOLICA lek. Robert Witek

    Tarnow, 33-100
    Poland

    Site Not Available

  • Hospital A Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, 41950
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova

    Lleida, 25198
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova-Lleida-17625

    Lleida, 25198
    Spain

    Site Not Available

  • Clínica Universidad de Navarra - Madrid

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital de Canarias

    San Cristóbal de La Laguna, 38320
    Spain

    Site Not Available

  • Ladulaas Kliniska Studier

    Borås, 506 30
    Sweden

    Site Not Available

  • Forskningsenheten Carlanderska

    Göteborg, 40545
    Sweden

    Site Not Available

  • Pharmasite Malmo

    Malmö, 211 52
    Sweden

    Site Not Available

  • Sabbatsbergs sjukhus

    Stockhom, 113 61
    Sweden

    Site Not Available

  • Medicinmottagning 5/Överviktsenheten

    Örebro, 70362
    Sweden

    Site Not Available

  • Waterloo Medical Centre

    Blackpool, FY4 3AD
    United Kingdom

    Site Not Available

  • Bradford on Avon Health Centre

    Bradford on Avon, BA15 1DQ
    United Kingdom

    Site Not Available

  • Mounts Bay Medical Limited

    Hayle, TR27 5DT
    United Kingdom

    Site Not Available

  • Mounts Bay Medical Ltd

    Hayle, TR27 5DT
    United Kingdom

    Site Not Available

  • Clifton Medical Centre, Rotherham

    Rotherham, S65 1DA
    United Kingdom

    Site Not Available

  • Trowbridge Health Centre

    Trowbridge, BA14 8LW
    United Kingdom

    Site Not Available

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Site Not Available

  • EmVenio Research

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • EmVenio Research-Atlanta-69582

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Encompass Clinical Research, Spring Valley

    Spring Valley, California 91978
    United States

    Site Not Available

  • Diablo Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Alliance for Multispecialty Research-Coral Gables-68872

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • East Coast Institute for Research, LLC-Jacksonville-55146

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • New Horizon Research Center-Miami-69732

    Miami, Florida 33165
    United States

    Site Not Available

  • West Orange Endocrinology

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • East-West Medical Research

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Velocity Clinical Research

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Velocity Clinical Research-Valparaiso-68883

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Velocity Clinical Research

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Velocity Clinical Research-Sioux City-69728

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • AMR Lexington

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • StudyMetrix Research, LLC

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Walgreens Clinical Trials

    Atlantic City, New Jersey 08401
    United States

    Site Not Available

  • Walgreens Clinical Trials-Atlantic City-69647

    Atlantic City, New Jersey 08401
    United States

    Site Not Available

  • Walgreens Clinical Trials

    Perth Amboy, New Jersey 08861
    United States

    Site Not Available

  • Walgreens Clinical Trials-Perth Amboy-69648

    Perth Amboy, New Jersey 08861
    United States

    Site Not Available

  • Premier Research, Inc.

    Trenton, New Jersey 08611
    United States

    Site Not Available

  • Velocity Clinical Research, Vestal

    Vestal, New York 13850
    United States

    Site Not Available

  • Southgate Medical Group/ Southgate Medical Park

    West Seneca, New York 14224
    United States

    Site Not Available

  • Physicians East, PA

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Accellacare-Wilmington-67123

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Valley Weight Loss Clinic

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • EmVenio Research

    Oklahoma City, Oklahoma 73139
    United States

    Site Not Available

  • EmVenio Research-Oklahoma City-70053

    Oklahoma City, Oklahoma 73139
    United States

    Site Not Available

  • Emvenio

    Oklahoma City, Oklahoma 73107
    United States

    Active - Recruiting

  • Trial Management Associates

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Texas Diabetes and Endocrinology

    Austin, Texas 78731
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Site Not Available

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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