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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06077864
Other study ID # 1404-0040
Secondary ID 2022-502442-27-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 17, 2023
Est. completion date April 2, 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 (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 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 the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.


Recruitment information / eligibility

Status Recruiting
Enrollment 4935
Est. completion date April 2, 2026
Est. primary completion date March 12, 2026
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/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI =30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD. Further inclusion criteria apply. Exclusion criteria: 1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening. 2. Type 1 diabetes. 3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening. 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). Further exclusion criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
survodutide
once weekly subcutaneous injection
Placebo
once weekly subcutaneous injection

Locations

Country Name City State
Argentina CEDIC - Centro de Investigacion Clinica Caba
Argentina Mautalen- Salud e Investigación Caba
Argentina Centro de Investigaciones Metabólicas (CINME) Ciudad Autonoma Buenos Aires
Argentina Centro Medico Dra Laura Maffei Ciudad Autonoma Buenos Aires
Argentina Glenny Corp. S.A. Bioclinica Argentina Ciudad Autonoma Buenos Aires
Argentina Centro Médico Viamonte Ciudad Autonoma de Bs As
Argentina Sanatorio Güemes Ciudad Autónoma de Bs As
Argentina Centro de Investigaciones y Prevención Cardiovascular CIPREC Ciudad Autónoma de Buenos Aire
Argentina Consultorio de Investigación Clínica EMO SRL Ciudad Autónoma de Buenos Aire
Argentina CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegiani Córdoba
Argentina Centro de Investigaciones Médicas Mar del Plata Mar del Plata
Argentina Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata
Argentina Hospital Privado - Centro Médico de Córdoba S.A. Parque Velez Sarfield
Argentina CEMEDIC - Centro de Especialidades Medicas Villa Luro
Australia Royal Adelaide Hospital Adelaide South Australia
Australia The Boden Initiative Camperdown New South Wales
Australia Victorian Heart Hospital Clayton Victoria
Australia Repatriation General Hospital Daw Park South Australia
Australia Advara Heart Care Joondalup Western Australia
Australia Novatrials Kotara New South Wales
Australia Advara Heart Care Leabrook South Australia
Australia Royal Melbourne Hospital Parkville Victoria
Australia Royal North Shore Hospital St Leonards New South Wales
Australia AusTrials - Taringa Taringa Queensland
Australia AusTrials Wellers Hill Queensland
Austria Medical University of Graz State Hospital - University Hospital Graz Graz
Austria Medical University of Innsbruck Innsbruck
Austria LKH Salzburg University Hospital Salzburg
Austria Clinic Landstrasse Vienna
Austria Private Practice - Dr. Ursula Hanusch-Enserer Vienna
Belgium AZ Sint-Jan Brugge Brugge
Belgium Edegem - UNIV UZ Antwerpen Edegem
Belgium UZ Leuven Leuven
Brazil Hospital Universitário João de Barros Barreto Belém
Brazil Chronos Pesquisa Clinica Brasilia
Brazil L2IP -Instituto de Pesquisas Clínicas Ltda. Brasília
Brazil Cline Research Center Curitiba
Brazil Instituto de Estudos e Pesquisas Clínicas IEP-CE Fortaleza
Brazil Universidade Federal do Rio Grande do Sul Porto Alegre
Brazil Instituto Brasil de Pesquisa Clinica (IBPClin) Rio de Janeiro
Brazil ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas São José dos Campos
Brazil BR Trials Sao Paulo
Brazil CEPIC - Centro Paulista de Investigacao Clinica Sao Paulo
Brazil Irmandade da Santa Casa de Misericórdia de São Paulo - IPEC - Instituto de Pesquisa Clínica Sao Paulo
Brazil Cpquali Pesquisa Clinica Ltda São Paulo
Brazil Hospital das Clinicas da FMUSP São Paulo
Bulgaria MHAT "Yuliya Vrevska" EOOD, Byala Byala
Bulgaria MHAT - Dobrich, AD Dobrich
Bulgaria Multy profile hospital for active treatment Sv.Ivan Rilski Dupnitsa
Bulgaria MHAT "St. Caridad" Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment Trimontsium OOD Plovdiv
Bulgaria Multy Profile Hospital for active treatment Hadzhi Dimirar Sliven
Bulgaria Diagnostic & Consultancy Center "Ascendent", Sofia Sofia
Bulgaria Diagnostic Consultative Center Alexandrovska Sofia
Bulgaria Medical Center Synexus Sofia EOOD Sofia
Bulgaria MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia Sofia
Bulgaria University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD Sofia
Bulgaria Medical Center Berbatov Yambol
Bulgaria MHAT St Panteleimon Yambol
Canada Centricity Research (Brampton) Brampton Ontario
Canada Wharton Medical Clinic (Burlington) Burlington Ontario
Canada C-ENDO Diabetes & Endocrinology Clinic Calgary Alberta
Canada Richmond Road Diagnostic & Treatment Centre Calgary Alberta
Canada Cambridge Cardiac Care Centre Cambridge Ontario
Canada Ecogene-21 Chicoutimi Quebec
Canada Centricity Research (Etobicoke) Etobicoke Ontario
Canada QEII Health Sciences Centre Halifax Nova Scotia
Canada Hamilton Medical Research Group Hamilton Ontario
Canada Western Centre for Public Health & Family Medicine (LHRI) London Ontario
Canada Centricity Research (Oshawa) Oshawa Ontario
Canada Recherche Clinique Sigma Inc. Québec Quebec
Canada CARe Clinic Red Deer Alberta
Canada Bluewater Clinical Research Sarnia Ontario
Canada Surrey Memorial Hospital Surrey British Columbia
Canada Centre de Medecine Metabolique de Lanaudiere Terrebonne Quebec
Canada Canadian Phase Onward Inc. Toronto Ontario
Canada Centricity Research (Bayview) Toronto Ontario
Canada Diabetes Heart Research Centre Toronto Ontario
Canada Diex Recherche Trois-Rivieres Trois-Rivieres Quebec
Canada Victoria Heart Institute Foundation Victoria British Columbia
Canada Clinical Research Solutions Inc. Waterloo Ontario
Canada Winnipeg Clinic Winnipeg Manitoba
China Beijing Chao-Yang Hospital Beijing
China Beijing Pinggu Hospital Beijing
China Peking University First Hospital Beijing
China The Second Hospital of Jilin University Changchun
China Changzhou Second People's Hospital Changzhou
China Second Affiliated Hospital Chongqing Medical University Chongqing
China Hangzhou First People's Hospital Hangzhou
China The Second Affiliated Hospital of Nanjing Medical University Hangzhou
China Forth Clinical Hospital of Harbin Medical University Harbin
China The First Affiliated Hospital of University of South China Hengyang
China Huai'an first people's hospital Huai'an
China Huzhou Central Hospital Huzhou
China Center Hospital of Jinan Jinan
China Lishui Municipal Central Hospital Lishui
China The First Affiliated Hospital of Henan University of Science and Technology Luoyang
China Nanchang Third Hospital Nanchang
China Nanjing Drum Tower Hospital Nanjing
China Nanjing Jiangning Hospital Nanjing
China Zhongda Hospital Southeast University Nanjing
China The First Affiliated Hospital of Nanyang Medical College Nanyang
China The First Affiliated Hospital of Ningbo University Ningbo
China First Hospital of Qinhuangdao Qinhuangdao
China Shanghai Fifth People's Hospital affiliated to Fudan University Shanghai
China Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai
China Shanghai Pudong New District People's Hospital Shanghai
China Tongren hospital, Shanghai Jiaotong University School of Medicine Shanghai
China Zhongshan Hospital Affiliated to Fudan University Shanghai
China The Second Hospital of Hebei Medical University Shijiazhuang
China Suzhou Science & Technology Town Hospital Suzhou
China First Affiliated Hospital of Xi'an JiaoTong University Xi'an
China Shaanxi Provincial People's Hospital Xi'an
China The First Affiliated Hospital of Xi'an Medical University Xi'an
China Xianyang Hospital of Yan'an University Xianyang
China Affiliated Hospital of Jiangsu University Zhenjiang
Czechia University Hospital at St. Anna Brno
Czechia DIKa centrum s.r.o. Havirov
Czechia Center for Osteoporosis Therapy Karlovy Vary
Czechia Diabetology Krnov Krnov
Czechia Internal and Diabetes Clinic Nachod
Czechia PreventaMed, s.r.o. Olomouc
Czechia Internal ambulance Dialine s.r.o. Plzen
Czechia Institute for Clinical and Experimental Medicine Prague
Czechia OB Klinika Prague
Czechia Synexus Czech s.r.o. Prague
Czechia General Faculty Hospital, Prague Prague 2
Czechia ResTrial s.r.o. Praha 8
Denmark Aarhus University Hospital Aarhus N
Denmark Copenhagen University Hospital, Rigshospitalet Copenhagen
Denmark Herlev and Gentofte Hospital Herlev
Denmark Regionshospitalet Gødstrup Herning
Denmark Hvidovre Hospital Hvidovre
Finland CRST Helsinki Oy Helsinki
Finland StudyCor Oy Jyväskylä
Finland Terveystalo Pori Lääkäritalo Pori
Finland Tampere University Hospital Tampere
Finland Terveystalo Pulssi, Turku Turku
Germany Universitätsklinikum Aachen, AöR Aachen
Germany DRK Kliniken Berlin Köpenick Berlin
Germany Synexus Clinical Research GmbH Berlin
Germany Velocity Clinical Research Germany GmbH Berlin
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Universitätsklinikum Erlangen Erlangen
Germany Synexus Clinical Research GmbH Frankfurt
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany Universitätsklinikum Freiburg Freiburg
Germany Medizinische Hochschule Hannover Hannover
Germany Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany Universitätsklinikum Köln (AöR) Köln
Germany Synexus Clinical Research GmbH Leipzig
Germany Otto-von-Guericke-Universität Magdeburg Magdeburg
Germany Westfälische Wilhelms-Universität Münster Münster
Germany Universitätsklinikum Regensburg Regensburg
Germany Universitätsklinikum Tübingen Tübingen
Greece General Hospital of Athens "Laiko" Athens
Greece Attikon University Hospital Haidari-Athens
Greece University General Hospital of Heraklion Heraklion, Crete
Greece Univ. Gen. Hosp. of Ioannina Ioannina
Greece General University Hospital of Larissa Larissa
Greece Iatriko of Athens Group/ Iatriko of P. Faliro P. Faliro
Greece Iatriko Psychikou Psychiko
Greece Gen. Hosp. of Thessaloniki "Hippokation", Department of Endocrinology Thessaloniki
Greece University General Hospital of Thessaloniki AHEPA Thessaloniki
Hong Kong Prince of Wales Hospital Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Tung Wah Hospital Hong Kong
Hungary Lausmed Kft. Outpatient Unit of Internal Medicine Baja
Hungary Bajcsy-Zsilinszky Hospital and Clinic Budapest
Hungary Budapest Szent Ferenc Hospital Budapest
Hungary Central Hospital of Northern Pest - Military Hospital Budapest
Hungary Obuda Health Center Budapest
Hungary Semmelweis University Budapest
Hungary Synexus Hungary Healthcare Service Ltd. Budapest
Hungary University Debrecen Hospital Debrecen
Hungary Erzsebet Nursing Home Godollo
Hungary Synexus Hungary Healthcare Service Ltd Gyula
Hungary BKS Research Ltd Hatvan
Hungary Studium Egeszseghaz Kft. Kalocsa
Hungary Somogy County Kaposi Mor Teaching Hospital Kaposvar
Hungary SYNEXUS Hungary Health Care Services Ltd Zalaegerszeg
India Kamalnayan Bajaj Hospital Aurangabad
India S.P. Medical College & Associated Group of Hospitals Bikaner
India Apollo Speciality Hospital Chennai
India LPS Institute of Cardiology Kanpur
India Shrikrishna Hrudayalaya and Critical Care Centre Maharashtra
India Batra Hospital and Medical Research Centre New Delhi
India Sir Gangaram Hospital New Delhi
India Shri B.D. Mehta Mahavir Heart Institute Surat
Ireland St. Vincent's University Hospital Dublin 4
Italy Humanitas Gavazzeni Bergamo
Italy Centro Cardiologico Monzino-IRCCS Milano
Italy IRCCS MultiMedica Milano
Italy A.O. Univ. Policlinico "Paolo Giaccone" Palermo
Italy AOU Policlinico Umberto I Roma
Italy Poli Univ A. Gemelli Roma
Italy Università Campus Bio-Medico - ROMA Roma
Japan Chubu Rosai Hospital Aichi, Nagoya
Japan Daido Clinic Aichi, Nagoya
Japan Meitetsu Hospital Aichi, Nagoya
Japan Nagoya Kyoritsu Hospital Aichi, Nagoya
Japan Seikeikai New Tokyo Heart Clinic Chiba, Matsudo
Japan Takagi Hospital Fukuoka, Okawa
Japan Seino Internal Medicine Clinic Fukushima, Koriyama
Japan Matsuba Clinic Kanagawa, Kawasaki
Japan Sagamihara Kyodo Hospital Kanagawa, Sagamihara
Japan Saiseikai Yokohamashi Nanbu Hospital Kanagawa, Yokohama
Japan Kyoto Okamoto Memorial Hospital Kyoto, Kuse-gun
Japan Iryouhouijneiwakai Minamiakatsuka Clinic Mito, Ibaraki
Japan Sato Hospital Miyagi, Sendai
Japan Osaka Police Hospital Osaka, Osaka
Japan Saiseikai Kawaguchi Hospital Saitama, Kawaguchi
Japan Koshigaya Municipal Hospital Saitama, Koshigaya
Japan Saitama Sekishikai Hospital Saitama, Sayama
Japan Sayama General Clinic Saitama, Sayama
Japan Omihachiman Community Medical Center Shiga, Omihachiman
Japan Minamino Cardiovascular Hospital Tokyo, Hachioji
Japan NewHeart Watanabe Institute Tokyo, Suginami-ku
Japan Saiseikai Wakayama Hospital Wakayama, Wakayama
Kazakhstan Academy of Preventive Medicine, Clinic "Vitalem" Almaty
Kazakhstan Institute of Gastroenterology, Gepatology and Metabolism LLP Almaty
Kazakhstan Multidisciplinary City Hospital ?1 of the Akimat of Astana Astana
Kazakhstan National Research Medical Center (NNMC) Astana
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Pusan National Univ. Hosp Busan
Korea, Republic of Chungbuk National University Hospital Cheongju
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-si, Gangwon State
Mexico ENCLIFAR Ensayos Clinicos Farmacologicos, S.C. Chihuahua
Mexico Clinica Omega Diabetes Ciudad de Mexico
Mexico Instituto de Diabetes, Obesidad y Nutrición S.C. Cuernavaca
Mexico Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. Culiacan
Mexico CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc México
Mexico Cardiolink Clin Trials S.C. Monterrey
Netherlands Rijnstate Hospital Arnhem
Netherlands Spaarne Ziekenhuis Haarlem
Netherlands Diakonessenhuis Utrecht Utrecht
Netherlands Maxima Medisch Centrum Veldhoven
New Zealand Optimal Clinical Trials Auckland
New Zealand Pacific Clinical Research Network - Forte Christchurch Christchurch
New Zealand P3 Research Lower Hutt Lower Hutt
New Zealand P3 Research Palmerston North Palmerston North Migration Data
New Zealand Middlemore Clinical Trials Papatoetoe
New Zealand P3 Research Kapiti Paraparaumu
New Zealand Pacific Clinical Research Network - Rotorua Rotorua
Norway Vestre Viken HF, Drammen Sykehus Drammen
Norway Akershus Universitetssykehus HF Lørenskog
Norway Sykehuset i Vestfold, Avd. Tønsberg Tønsberg
Norway St. Olavs Hospital, Universitetssykehuset i Trondheim Trondheim
Poland Medical University of Bialystok Bialystok
Poland Trial Medica Bialystok
Poland INTERCORE Medical Center Bydgoszcz
Poland NZOZ Medical Center KERmed Bydgoszcz
Poland Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk Gdansk
Poland Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia Gdynia
Poland NZOZ Euromedica POZ Grudziadz
Poland Salvia Lekston I Madej Sp. J. Katowice
Poland Silmedic Sp. z o.o. Katowice
Poland Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice Katowice
Poland Vita Longa Sp. z o.o. Katowice
Poland Diab-Endo-Met Medical Center Krakow
Poland Unicardia Specialist Medical Center Krakow
Poland Med-Gastr Medical Center Lodz
Poland Synexus Lodz Medical Center Lodz
Poland Clinical Best Solutions Lublin
Poland Diabetology Outpatient Clinic NZOZ Specjal-Med, Lublin Lublin
Poland Medeusz-Plus Olsztyn
Poland Metabolic Health Center Pawel Bogdanski Poznan
Poland Private Practice Dr. Ewa Krzyzagorska Poznan
Poland Synexus Poland, Branch in Poznan Poznan
Poland Padre Pio Regional Hospital in Przemysl Przemysl
Poland MEDYK Medical Center Rzeszow
Poland ETG Skierniewice Skierniewice
Poland NZOZ Procordis, Cardiology Research Center of Sopot Sopot
Poland Velocity Staszow Staszow
Poland DC-MED Swidnica
Poland ETG Warszawa Warsaw
Poland National Medical Institute MSWiA Warsaw
Poland NBR Polska Warsaw
Poland Clinical Best Solutions Sp. z o.o. S.K. Warszawa
Poland Synexus Poland, Branch in Wroclaw Wroclaw
Portugal Hospital de Cascais Dr. José de Almeida Alcabideche
Portugal ULS da Região de Aveiro Aveiro
Portugal ULS Braga Braga
Portugal ULS de Coimbra, E.P.E. Coimbra
Portugal ULS do Alto Ave Guimarães
Portugal APDP - Associação Protectora dos Diabéticos de Portugal Lisboa
Portugal Hospital da Luz Lisboa
Portugal ULS de São José Lisboa
Portugal Cardiolima - Centro Diagnostico Cardio-pulmonar de Ponte de Lima, Lda. Ponte de Lima
Portugal ULS de Entre Douro e Vouga Santa Maria da Feira
Portugal UCARDIO Torres Novas
Puerto Rico Advanced Clinical Research Bayamon
Puerto Rico Ponce School of Medicine/CAIMED Center Ponce
Saudi Arabia King Fahad Specialist Hospital - Research Center Dammam
Saudi Arabia King AbdulAziz University Hospital Jeddah
Saudi Arabia King Faisal Specialist Hospital and Research Center Riyadh
Saudi Arabia King Saud Medical City Riyadh
Slovakia MEDISPEKTRUM s.r.o., Bratislava Bratislava
Slovakia METABOL KLINIK s.r.o., Bratislava Bratislava
Slovakia Human-Care s.r.o. Kosice
Slovakia Medical Group Kosice s.r.o Kosice
Slovakia IN-DIA s.r.o., Lucenec Lucenec
Slovakia Funkystuff s.r.o. Nove Zamky
Slovakia DIAB sro Roznava
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Universitario de Badajoz Badajoz
Spain Centro Médico Teknon Barcelona
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital de Basurto Bilbao
Spain Hospital Universitari de Girona Doctor Josep Trueta Girona
Spain Hospital Universitario San Cecilio Granada
Spain Hospital La Paz Madrid
Spain Hospital Virgen de la Victoria Malaga
Spain Hospital Quirónsalud Madrid Pozuelo de Alarcón
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Hospital Quironsalud Infanta Luisa Sevilla
Spain Hospital Dr. Peset Valencia
Taiwan Chang-Hua Christian Hospital Changhua
Taiwan Chia-Yi Christian Hospital Chia-Yi City
Taiwan China Medical University Hospital Taichung
Taiwan NCKUH Tainan
Taiwan National Taiwan University Hospital Taipei City
Taiwan Chang Gung Memorial Hospital(Linkou) Taoyuan County
Turkey Adana City Hospital Adana
Turkey Akdeniz UTF Endokrinoloji ve Metabolizma Hastaliklari BD Antalya
Turkey Inonu Uni. Med. Fac., Battalgazi Battalgazi
Turkey Bursa Yuksek Ihtisas EAH Bursa
Turkey Dicle Universitesi Tip Fakultesi Diyarbakir
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Istanbul
Turkey Zonguldak Bulent Ecevit UTF Zonguldak
United Kingdom University Hospital Monklands Airdrie
United Kingdom Antrim Area Hospital Antrim
United Kingdom Heartlands Hospital Birmingham
United Kingdom Synexus Wales - Cardiff Cardiff
United Kingdom Synexus Lancashire Chorley
United Kingdom Ninewells Hospital & Medical School Dundee
United Kingdom Synexus - Midlands Edgbaston
United Kingdom Wellcome Trust Clinical Research Facility, Edinburgh Edinburgh
United Kingdom Queen Elizabeth University Hospital Glasgow
United Kingdom Synexus - Glasgow Glasgow
United Kingdom Synexus - Hexham Hexham
United Kingdom Leicester General Hospital Leicester
United Kingdom Lincoln County Hospital Lincoln
United Kingdom Synexus Merseyside - Liverpool Liverpool
United Kingdom William Harvey Research Limited London
United Kingdom Altnagelvin Area Hospital Londonderry
United Kingdom Manchester Royal Infirmary Manchester
United Kingdom Synexus Manchester Manchester
United Kingdom Patient Recruitment Centre: Newcastle Newcastle upon Tyne
United Kingdom Swansea University Medical School Swansea
United Kingdom University Hospital Wishaw Wishaw
United States Javara Albany Georgia
United States IMA Clinical Research Albuquerque Albuquerque New Mexico
United States Amarillo Medical Specialists Amarillo Texas
United States McFarland Clinic PC Ames Iowa
United States Synexus - Anderson Anderson South Carolina
United States Velocity Clinical Research Anderson South Carolina
United States Javara Inc. Annapolis Maryland
United States Washington Center for Weight Management and Research, Inc. Arlington Virginia
United States Northwest Heart Clinical Research, LLC Arlington Heights Illinois
United States Velocity Clinical Research, Austin Austin Texas
United States Ascension Saint Agnes Heart Care Baltimore Maryland
United States Heritage Valley Medical Group Beaver Pennsylvania
United States National Diabetes and Obesity Research Institute Biloxi Mississippi
United States Meridian Clinical Research, LLC Binghamton New York
United States Cardiology P.C. Birmingham Alabama
United States Excel Medical Clinical Trials Boca Raton Florida
United States Proactive Clinical Research Boca Raton Florida
United States Grace Research, LLC Bossier City Louisiana
United States Brigham and Women's Hospital Boston Massachusetts
United States Bridgeport Hospital Bridgeport Connecticut
United States Internal Medicine and Pediatric Associates of Bristol, PC Bristol Tennessee
United States Headlands Research Brownsville Texas
United States Mercury Street Medical Butte Montana
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Accellacare of Cary Cary North Carolina
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Javara Charlotte North Carolina
United States Chattanooga Research & Medicine, PLLC Chattanooga Tennessee
United States Cedar Crosse Research Center Chicago Illinois
United States Research by Design, LLC Chicago Illinois
United States Velocity Clinical Research Cincinnati Ohio
United States Clinical Research of West Florida, Inc. Clearwater Florida
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Centricity Research Columbus Georgia
United States Centricity Research Columbus Ohio
United States Synexus Clinical Research Columbus Ohio
United States Privia Medical Group Gulf Coast, PLLC Conroe Texas
United States Nature Coast Clinical Research Crystal River Florida
United States Beautiful Minds Clinical Research Center Cutler Bay Florida
United States Velocity Clinical Research Dallas Texas
United States AMR Daphne Daphne Alabama
United States Physicians' Research Options. LLC Draper Utah
United States Aventiv Research Inc. Dublin Ohio
United States Velocity Clinical Research East Greenwich Rhode Island
United States Tekton Research Edmond Oklahoma
United States AMR El Dorado El Dorado Kansas
United States Skyline Medical Center Elkhorn Nebraska
United States Medisphere Medical Research Center Evansville Indiana
United States Seven Corners Medical Center Falls Church Virginia
United States Prime Health and Wellness Fayette Mississippi
United States Javara Fayetteville Georgia
United States Elite Research Center, LLC Flint Michigan
United States AMR Fort Myers Fort Myers Florida
United States Covenant Metabolic Specialists, LLC Fort Myers Florida
United States Texas Health Care PLLC Fort Worth Texas
United States Methodist Physicians Clinic Fremont Nebraska
United States Velocity Clinical Research Gaffney South Carolina
United States Healthy Heart Cardiology Grand Rapids Michigan
United States Tribe Clinical Research LLC Greenville South Carolina
United States Velocity Clinical Research Greenville South Carolina
United States Velocity Clinical Research Gulfport Mississippi
United States Velocity Clinical Research Hallandale Beach Florida
United States CMR of Greater New Haven, LLC Hamden Connecticut
United States Heart Clinic of Hammond Hammond Louisiana
United States Houston Research Institute Houston Texas
United States Velocity Clinical Research Huntington Park California
United States Westside Center for Clinical Research Jacksonville Florida
United States NSC Research Inc Johns Creek Georgia
United States AMR Kansas City Kansas City Missouri
United States Clinical Research Consultants, LLC Kansas City Missouri
United States Clinical Investigation Specialists, Inc. Kenosha Wisconsin
United States Accellacare of Knoxville Knoxville Tennessee
United States Accellacare of Knoxville Knoxville Tennessee
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States Velocity Clinical Research La Mesa California
United States AMR Las Vegas Las Vegas Nevada
United States Alliance for Multispecialty Research, LLC Layton Utah
United States Clinical Site Partners LLC Leesburg Florida
United States Lynn Institute of the Ozarks Little Rock Arkansas
United States Velocity Clinical Research Los Angeles California
United States East Coast Institute for Research, LLC Macon Georgia
United States Urban Family Practice Associates, PC Marietta Georgia
United States Tandem Clinical Research Marrero Louisiana
United States Velocity Clinical Research Medford Oregon
United States Clinical Neuroscience Solutions, Inc Memphis Tennessee
United States Arizona Liver Health Mesa Arizona
United States Clinical Trial Services, Corp Miami Florida
United States Suncoast Research Group Miami Florida
United States Verus Clinical Research Corporation Miami Florida
United States AMR Mobile Mobile Alabama
United States Mobile Heart Specialists, PC Mobile Alabama
United States Catalina Research Institute, LLC Montclair California
United States Accellacare Mooresville North Carolina
United States Clinical Research Associates, Inc Nashville Tennessee
United States Lucas Research New Bern North Carolina
United States AMR New Orleans New Orleans Louisiana
United States Synexus Clinical Research US, Inc. New York New York
United States AMR Newton Newton Kansas
United States Eastern Virginia Medical School Norfolk Virginia
United States AMR Norman Norman Oklahoma
United States Lynn Institute of Norman Norman Oklahoma
United States Coastal Carolina Research Center North Charleston South Carolina
United States Valley Clinical Trials, Inc. Northridge California
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States South Oklahoma Heart Research Group Oklahoma City Oklahoma
United States Research Integrity, LLC Owensboro Kentucky
United States MD Medical Research Oxon Hill Maryland
United States Velocity Clinical Research Panorama City California
United States Tristar Clinical Investigations PC Philadelphia Pennsylvania
United States Synexus Pinellas Park Florida
United States Preferred Primary Care Physicians Pittsburgh Pennsylvania
United States Mayo Clinic, Rochester Rochester Minnesota
United States East Coast Institute for Research, LLC Saint Augustine Florida
United States Chrysalis Clinical Research Saint George Utah
United States Sundance Clinical Research, LLC Saint Louis Missouri
United States Synexus Clinical Research Salt Lake City Utah
United States IMA Clinical Research San Antonio San Antonio Texas
United States Tekton Research San Antonio Texas
United States Javara Inc. and Privia Medical Group Gulf Coast, PLLC San Marcos Texas
United States NorCal Endocrinology and Internal Medicine San Ramon California
United States Velocity Clinical Research Santa Ana California
United States NorthBay Clinical Research, LLC Santa Rosa California
United States Covenant Metabolic Specialists, LLC Sarasota Florida
United States Saratoga Clinical Research, LLC Saratoga Springs New York
United States Javara Savannah Georgia
United States Velocity Clinical Research Seattle Washington
United States Grace Research, LLC Shreveport Louisiana
United States Velocity Clinical Research Spokane Washington
United States Clinvest Research LLC Springfield Missouri
United States Javara Inc. Stephenville Texas
United States Clinical Research Institute of Arizona, LLC Sun City West Arizona
United States Lenus Research & Medical Group Sweetwater Florida
United States Santos Research Center, Corp. Tampa Florida
United States AMR Phoenix Tempe Arizona
United States DM Clinical Research - Martin Diagnostic Clinic Tomball Texas
United States Arizona Liver Health Tucson Arizona
United States Velocity Clinical Research Union South Carolina
United States Preferred Primary Care Physicians Uniontown Pennsylvania
United States Impact Research Institute Waco Texas
United States IMA Clinical Research Warren New Jersey
United States Chase Medical Research, LLC Waterbury Connecticut
United States Allegiance Research Specialists Wauwatosa Wisconsin
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
United States Velocity Clinical Research West Jordan Utah
United States Clinical Research Institute of Ohio, LLC Westlake Ohio
United States AMR Wichita East Wichita Kansas
United States Selma Medical Associates, Winchester Winchester Virginia
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Yuma Clinical Trials Yuma Arizona

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Italy,  Japan,  Kazakhstan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Saudi Arabia,  Slovakia,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction up to Week 114
Secondary Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority) up to Week 114
Secondary Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72 Baseline and at Week 72
Secondary Absolute change in waist circumference (cm) from baseline to Week 72 Baseline and at Week 72
Secondary Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better. At Baseline and at Week 72
Secondary Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority) up to Week 114
Secondary Percentage change in body weight from baseline to Week 72 Baseline and at Week 72
Secondary Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72 Baseline and at Week 72
Secondary Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72 Baseline and at Week 72
Secondary Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72 Baseline and at Week 72
Secondary Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM) Baseline and at Week 72
Secondary Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM Baseline and at Week 72
Secondary Time to onset of T2DM in trial participants without T2DM at baseline up to Week 114
Secondary Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE)) up to Week 114
Secondary Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE) up to Week 114
Secondary Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE) up to Week 114
Secondary Time to first occurrence of adjudicated CV death or adjudicated HFE up to Week 114
Secondary Time to first occurrence of adjudicated CV death or adjudicated HHF up to Week 114
Secondary Time to first occurrence of adjudicated HFE up to Week 114
Secondary Time to adjudicated CV death up to Week 114
Secondary Time to all-cause mortality up to Week 114
Secondary Time to first occurrence of adjudicated non-fatal MI up to Week 114
Secondary Time to first occurrence of adjudicated non-fatal stroke up to Week 114
Secondary Time to first occurrence of adjudicated ischaemia related coronary revascularisation up to Week 114
Secondary Achievement of body weight reduction =5% from baseline to Week 72 Baseline and at Week 72
Secondary Achievement of body weight reduction =10% from baseline to Week 72 Baseline and at Week 72
Secondary Achievement of body weight reduction =15% from baseline to Week 72 Baseline and at Week 72
Secondary A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline Win ratio will be assessed as below:
The primary efficacy endpoint will be analyzed using the clinical benefit approach comparing every participant in the BI 456906 arm to every participant in the placebo arm to determine a winner.
A winner in the pair-wise comparison has a delayed time to the occurrence of death; if that cannot be determined, a winner has fewer HFEs; if the number of HFEs is the same a winner has a delayed time to the occurrence of first HFE; if that rule does not determine a winner, a winner has a more favorable (less increase or more decrease) change in KCCQ-CSS between baseline and at 72 weeks, otherwise the pair will be recorded as tied. The estimated net benefit (win ratio is then calculated as the total number of wins in the BI 456906 group across all strata divided by the total number of losses) will be provided.
KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.
At baseline and at 72 Weeks
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