Phase
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
BI 456906
Placebo
survodutide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
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.
- History of at least one self-reported unsuccessful dietary effort to lose bodyweight.
Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
Body weight change (self-reported) of >5% within 3 months before screening.
Treatment with any medication for the indication obesity within 3 months beforescreening.
Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the centrallaboratory at screening.
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.
Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
Known clinically significant gastric emptying abnormality (e.g. severe diabeticgastroparesis or gastric outlet obstruction).
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.
Personal or family history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN 2).
Further exclusion criteria apply.
Study Design
Connect with a study center
Hunter Diabetes Centre
Merewether, New South Wales 2291
AustraliaSite Not Available
CORE Research Group
Milton, Queensland 4064
AustraliaSite Not Available
Griffith Health
Southport, Queensland 4125
AustraliaSite Not Available
Monash University
Box Hill, Victoria 3128
AustraliaSite Not Available
Austin Health
Heidelberg, Victoria 3084
AustraliaSite Not Available
Baker Heart and Diabetes Institute
Melbourne, Victoria 3004
AustraliaSite Not Available
Keogh Institute for Medical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
ASZ - Campus Aalst
Aalst, 9300
BelgiumSite Not Available
ULB Hopital Erasme
Bruxelles, 1070
BelgiumSite Not Available
Edegem - UNIV UZ Antwerpen
Edegem, 2650
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Roeselare - HOSP AZ Delta
Roeselare, 8800
BelgiumSite Not Available
Dr. James Lai
Vancouver, British Columbia V5Z 4E1
CanadaSite Not Available
Aggarwal and Associates Ltd.
Brampton, Ontario L6T 0G1
CanadaSite Not Available
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton, Ontario L8L 5G8
CanadaSite Not Available
Milestone Research Inc.
London, Ontario N5W 6A2
CanadaSite Not Available
James Cha, MD
Oshawa, Ontario L1J 2K1
CanadaSite Not Available
Stouffville Medical Centre
Stouffville, Ontario L4A 1H2
CanadaSite Not Available
Albion Finch Medical Centre
Toronto, Ontario M9V 4B4
CanadaSite Not Available
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
ViaCar Recherche Clinique Inc
Brossard, Quebec J4Z 2K9
CanadaSite Not Available
ViaCar Recherches Cliniques Inc. (Greenfield Park)
Greenfield Park, Quebec J4V 2G8
CanadaSite Not Available
Power Clinical Research
Montreal, Quebec H3M 1L3
CanadaSite Not Available
Recherche GCP Research
Montreal, Quebec H1Y 3H5
CanadaSite Not Available
Beijing Pinggu Hospital
Beijing, 101200
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
Changzhou Second People's Hospital
Changzhou, 213004
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, 510080
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Hangzhou, 210011
ChinaSite Not Available
Forth Clinical Hospital of Harbin Medical University
Harbin, 150599
ChinaSite Not Available
2nd Hospital Affiliated to Zhengzhou University
Henan Province, 100029
ChinaSite Not Available
Huzhou Central Hospital
Huzhou, 313000
ChinaSite Not Available
Center Hospital of Jinan
Jinan, 250013
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
ChinaSite Not Available
Pingxiang People's Hospital
Pingxiang, 337000
ChinaSite Not Available
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, 200240
ChinaSite Not Available
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, 200071
ChinaSite Not Available
Siping Central People's Hospital
Siping, 136000
ChinaSite Not Available
Suzhou Municipal Hospital
Suzhou, 215002
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 30052
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Medical University
Xi'an, 710077
ChinaSite Not Available
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, 100029
ChinaSite Not Available
Affiliated Hospital of Jiangsu University
Zhenjiang, 212013
ChinaSite Not Available
HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
Helsinki, 00290
FinlandSite Not Available
StudyCor Oy
Jyväskylä, 40620
FinlandSite Not Available
Itä-Suomen yliopisto/Health Step Finland Oy
Kuopio, 70210
FinlandSite Not Available
CRST - Clinical Research Services Turku
Turku, 20520
FinlandSite Not Available
InnoDiab Forschung GmbH
Essen, 45136
GermanySite Not Available
MVZ im Altstadt-Caree Fulda GmbH
Fulda, 36037
GermanySite Not Available
Diabetes Zentrum Hamburg West
Hamburg, 22607
GermanySite Not Available
Institut für Diabetesforschung Münster GmbH
Münster, 48145
GermanySite Not Available
RED Institut GmbH
Oldenburg, 23758
GermanySite Not Available
Forschungszentrum Ruhr, KliFo Center GmbH
Witten, 58455
GermanySite Not Available
Fukuhama Chuo Clinic
Fukuoka, Fukuoka, 810-0066
JapanSite Not Available
Kobe University Hospital
Hyogo, Kobe, 650-0017
JapanSite Not Available
Noritake Clinic
Ibaraki, Ushiku, 300-1207
JapanSite Not Available
Soka Sugiura Naika Clinic
Saitama, Soka, 340-0034
JapanSite Not Available
Hachioji Diabetes Clinic
Tokyo, Hachioji, 192-0083
JapanSite Not Available
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, 14647
Korea, Republic ofSite Not Available
Kyungpook National Univ. Hosp
Daegu, 700-721
Korea, Republic ofSite Not Available
Dongguk University Ilsan Hospital
Goyang, 10326
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam, 13620
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 110-746
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon, 16499
Korea, Republic ofSite Not Available
PT & R
Born, 6121 XK
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 EZ
NetherlandsSite Not Available
Bethesda Diabetes Research Center, Hoogeveen
RA Hoogeveen, 7900
NetherlandsSite Not Available
Franciscus Gasthuis
Rotterdam, 3045 PM
NetherlandsSite Not Available
P3 Research Dunedin
Dunedin, 9016
New ZealandSite Not Available
Southern Clinical Trials Tasman
Nelson, 7011
New ZealandSite Not Available
P3 Research
Newtown Wellington NZ, 6021
New ZealandSite Not Available
P3 Research-Newtown Wellington NZ-33770
Newtown Wellington NZ, 6021
New ZealandSite Not Available
Optimal Clinical Trials North
Rosedale, Auckland, 0632
New ZealandSite Not Available
P3 Research
Tauranga, 3110
New ZealandSite Not Available
P3 Research-Tauranga-34833
Tauranga, 3110
New ZealandSite Not Available
PI HOUSE Sp. z o.o., Gdansk
Gdansk, 80-546
PolandSite Not Available
ETG Lublin
Lublin, 20-412
PolandSite Not Available
KOMED Marek Konieczny
Pulawy, 24-100
PolandSite Not Available
Velocity Nova Sp z o.o.
Pulawy, 24-100
PolandSite Not Available
ETG Siedlce
Siedlce, 08-110
PolandSite Not Available
Clinical Research Center METABOLICA lek. Robert Witek
Tarnow, 33-100
PolandSite Not Available
Ladulaas Kliniska Studier
Borås, 506 30
SwedenSite Not Available
Forskningsenheten Carlanderska
Göteborg, 40545
SwedenSite Not Available
Pharmasite Malmo
Malmö, 211 52
SwedenSite Not Available
Sabbatsbergs sjukhus
Stockholm, 113 61
SwedenSite Not Available
Sabbatsbergs sjukhus
Stockhom, 113 61
SwedenSite Not Available
Medicinmottagning 5/Överviktsenheten
Örebro, 70362
SwedenSite Not Available
Waterloo Medical Centre
Blackpool, FY4 3AD
United KingdomSite Not Available
Bradford on Avon Health Centre
Bradford on Avon, BA15 1DQ
United KingdomSite Not Available
Burbage Surgery
Burbage, Hinkley, LE10 2SE
United KingdomSite Not Available
Kiltearn Medical Centre
Nantwich, CW5 5NX
United KingdomSite Not Available
Clifton Medical Centre, Rotherham
Rotherham, S65 1DA
United KingdomSite Not Available
Trowbridge Health Centre
Trowbridge, BA14 8LW
United KingdomSite Not Available
EmVenio Research
Phoenix, Arizona 85032
United StatesSite Not Available
EmVenio Research-Phoenix-69743
Phoenix, Arizona 85032
United StatesSite Not Available
Encompass Clinical Research, Spring Valley
Spring Valley, California 91978
United StatesSite Not Available
Diablo Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06519
United StatesSite Not Available
Alliance for Multispecialty Research
Coral Gables, Florida 33134
United StatesSite Not Available
Alliance for Multispecialty Research-Coral Gables-68872
Coral Gables, Florida 33134
United StatesSite Not Available
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
East Coast Institute for Research, LLC
Jacksonville, Florida 32216
United StatesSite Not Available
East Coast Institute for Research, LLC-Jacksonville-55146
Jacksonville, Florida 32216
United StatesSite Not Available
New Horizon Research Center
Miami, Florida 33165
United StatesSite Not Available
New Horizon Research Center-Miami-69732
Miami, Florida 33165
United StatesSite Not Available
West Orange Endocrinology
Ocoee, Florida 34761
United StatesSite Not Available
East-West Medical Research
Honolulu, Hawaii 96814
United StatesSite Not Available
Solaris Clinical Research
Meridian, Idaho 83646
United StatesSite Not Available
Evanston Premier Healthcare Research LLC
Skokie, Illinois 60077
United StatesSite Not Available
Velocity Clinical Research
Valparaiso, Indiana 46383
United StatesSite Not Available
Velocity Clinical Research-Valparaiso-68883
Valparaiso, Indiana 46383
United StatesSite Not Available
Velocity Clinical Research
Sioux City, Iowa 51106
United StatesSite Not Available
Velocity Clinical Research-Sioux City-69728
Sioux City, Iowa 51106
United StatesSite Not Available
AMR Lexington
Lexington, Kentucky 40509
United StatesSite Not Available
L-MARC Research Center
Louisville, Kentucky 40213
United StatesSite Not Available
StudyMetrix Research, LLC
Saint Peters, Missouri 63303
United StatesSite Not Available
Premier Research, Inc.
Trenton, New Jersey 08611
United StatesSite Not Available
Velocity Clinical Research, Vestal
Vestal, New York 13850
United StatesSite Not Available
Southgate Medical Group/ Southgate Medical Park
West Seneca, New York 14224
United StatesSite Not Available
Physicians East, PA
Greenville, North Carolina 27834
United StatesSite Not Available
Lucas Research, Inc.
Morehead City, North Carolina 28557
United StatesSite Not Available
Accellacare
Wilmington, North Carolina 28401
United StatesSite Not Available
Accellacare-Wilmington-67123
Wilmington, North Carolina 28401
United StatesSite Not Available
Valley Weight Loss Clinic
Fargo, North Dakota 58104
United StatesSite Not Available
EmVenio Research
Oklahoma City, Oklahoma 73139
United StatesSite Not Available
EmVenio Research-Oklahoma City-70053
Oklahoma City, Oklahoma 73139
United StatesSite Not Available
Emvenio
Oklahoma City, Oklahoma 73107
United StatesActive - Recruiting
Trial Management Associates
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Texas Diabetes and Endocrinology
Austin, Texas 78731
United StatesSite Not Available
Juno Research, LLC
Houston, Texas 77040
United StatesSite Not Available
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas 78229
United StatesSite Not Available
Consano Clinical Research
Shavano Park, Texas 78231
United StatesSite Not Available
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available
Rainier Clinical Research Center
Renton, Washington 98057
United StatesSite Not Available
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