Obesity Clinical Trial
Official title:
A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEDIC - Centro de Investigacion Clinica | 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 | 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 | 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 | Zhongshan Hospital Affiliated to Fudan University | Shanghai | |
| China | The Second Hospital of Hebei Medical University | Shijiazhuang | |
| China | Suzhou Science & Technology Town Hospital | Suzhou | |
| 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 Neurologische Klinik | 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 | 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 | |
| Hungary | Lausmed Kft. Outpatient Unit of Internal Medicine | Baja | |
| Hungary | Bajcsy-Zsilinszky Hospital and Clinic | Budapest | |
| Hungary | Budapest Szent Ferenc 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 | 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 | Shri B.D. Mehta Mahavir Heart Institute | Surat | |
| Ireland | St. Vincent's University Hospital | Dublin 4 | |
| Italy | Humanitas Gavazzeni | Bergamo | |
| 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 | 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 | 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 | Clinica Omega Diabetes | Ciudad de Mexico | |
| 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 | |
| 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 | KO-MED Centra Kliniczne 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 | 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 | 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 | 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 | 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
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,
| 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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