A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Last updated: April 17, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

BI 456906

Placebo

survodutide

Clinical Study ID

NCT06066515
1404-0038
U1111-1288-9400
2022-502529-17-00
  • 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 (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.

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) ≥30 kg/m^2 at screening, OR BMI ≥27 kg/m^2 with the presenceof at least one of the obesity-related complications (treated or untreated) e.g,:

  • Hypertension (defined as repeated, i.e. at least 3 measurements in restingcondition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absenceof anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drugto maintain a normotensive blood pressure)

  • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required tomaintain normal blood lipid levels, or low-density lipoprotein (LDL)cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7mmol/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.

  1. 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. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the centrallaboratory at screening.

  4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) ortreatment with glucose lowering agent started within 3 months before the screeningup to and including the randomisation visit.

  5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.

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

  7. History of either chronic or acute pancreatitis or elevation of serum lipase orserum pancreatic amylase >2x upper limit of normal (ULN) as measured by the centrallaboratory at screening.

  8. 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: 727
Treatment Group(s): 3
Primary Treatment: BI 456906
Phase: 3
Study Start date:
November 25, 2023
Estimated Completion Date:
February 13, 2026

Connect with a study center

  • 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

  • ULB Hopital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800
    Belgium

    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

  • ViaCar Recherche Clinique Inc

    Brossard, Quebec J4Z 2K9
    Canada

    Site Not Available

  • ViaCar Recherches Cliniques Inc. (Greenfield Park)

    Greenfield Park, Quebec J4V 2G8
    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

  • HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

    Helsinki, 00290
    Finland

    Site Not Available

  • StudyCor Oy

    Jyväskylä, 40620
    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

  • Fukuhama Chuo Clinic

    Fukuoka, Fukuoka, 810-0066
    Japan

    Site Not Available

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017
    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

  • 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

    Site Not Available

  • 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

  • Franciscus Gasthuis

    Rotterdam, 3045 PM
    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, 80-546
    Poland

    Site Not Available

  • ETG Lublin

    Lublin, 20-412
    Poland

    Site Not Available

  • KOMED Marek Konieczny

    Pulawy, 24-100
    Poland

    Site Not Available

  • 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

  • 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

    Stockholm, 113 61
    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

  • Burbage Surgery

    Burbage, Hinkley, LE10 2SE
    United Kingdom

    Site Not Available

  • Kiltearn Medical Centre

    Nantwich, CW5 5NX
    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

  • EmVenio Research

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • EmVenio Research-Phoenix-69743

    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

  • Yale University School of Medicine

    New Haven, Connecticut 06519
    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

  • 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

  • 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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