Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

Obesity Clinical Trial

— SELECT  

Official title:

SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574597
• Other study ID #: EX9536-4388
• Secondary ID: 2017-003380-35U1
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2018
• Est. completion date: June 29, 2023

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17609
• Est. completion date: June 29, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male or female, age greater than or equal to 45 years at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 27 kg/m^2
• Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease Exclusion Criteria:

Cardiovascular-related:

• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
• Presently classified as being in New York Heart Association (NYHA) Class IV heart failure

Glycaemia-related:

• HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
• History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
• Treatment with glucose-lowering agents within 90 days before screening
• Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening

General safety:

• History or presence of chronic pancreatitis
• Presence of acute pancreatitis within the past 180 days prior to the day of screening
• Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
• End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
• Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
• Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
• Known or suspected hypersensitivity to trial products or related products
• Previous participation in this trial. Participation is defined as randomisation
• Receipt of any investigational medicinal product within 30 days before screening
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
• Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Semaglutide
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.
• Placebo (semaglutide)
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.

Locations

Country	Name	City	State
Algeria	Cardiology department CHU Mustapha Pacha. Algiers	Algiers
Algeria	Centre National De la Médecine du Sport	Algiers
Algeria	CHU - Hussein dey Cardiology department Nafissa Hamoud	Algiers
Algeria	CHU Issad Hassani, Beni Messous, Cardiology department	Algiers
Algeria	Cardiology department, Benaouda Benzerdjeb CHU Oran	Oran
Argentina	Centro de Investigación y Prevención Cardiovascular	Caba
Argentina	Centro Médico MEDEOS	Caba
Argentina	Clínica Adventista Belgrano	Caba
Argentina	Fundacion Favaloro	Caba
Argentina	Glenny Corp. S.A	Caba
Argentina	Medical Center of Diabetes and Nutrition	Caba
Argentina	Sanatorio Güemes	Caba	City Of Buenos Aires
Argentina	Instituto Médico DAMIC	Córdoba
Argentina	Instituto de Cardiología de Corrientes	Corrientes
Argentina	Sanatorio Plaza	Rosario
Australia	Royal Adelaide Hospital Cardiovascular Clinical Trials	Adelaide	South Australia
Australia	Monash Cardiovascular Research Centre	Clayton	Victoria
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	The Canberra Hospital_Garran	Garran	Australian Capital Territory
Australia	Geelong Cardiology Research Unit	Geelong	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Austin Health, Metabolic Disorders Centre	Heidelberg Heights	Victoria
Australia	HeartCare WA (Joondalup)	Joondalup	Western Australia
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Hunter Diabetes Centre	Merewether	New South Wales
Australia	Advara HeartCare	Milton	Queensland
Australia	Core Research Centre	Milton	Queensland
Australia	Cholesterol Care Australia	Wollongabba	Queensland
Austria	Universitätsklinik für Innere Medizin	Graz
Austria	Univ.-Klinik für Innere Medizin I	Innsbruck
Austria	LKH Salzburg Universitätsklinikum	Salzburg
Austria	Klinik Hietzing	Wien
Austria	Klinik Landstraße	Wien
Austria	Ordination Dr. Hanusch	Wien
Austria	Universitätsklinikum AKH Wien	Wien
Belgium	Algemeen Stedelijk Ziekenhuis - Aalst - Interventional Cardiology	Aalst
Belgium	Imeldaziekenhuis - Bonheiden - Department of Endocrinology	Bonheiden
Belgium	CUB Hôpital Erasme_Brussels_1	Bruxelles
Belgium	Ziekenhuis Oost-Limburg AV - Cardiology	Genk
Belgium	UZ Gent - Cardiology	Gent
Belgium	UZ Gent_Gent_4	Gent
Belgium	Jessa Ziekenhuis - Hasselt - Cardiology	Hasselt
Brazil	AngioCor Blumenau	Blumenau	Santa Catarina
Brazil	Hospital do Coração do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	Sao Paulo
Brazil	Cline Research Center	Curitiba	Parana
Brazil	Núcleo de Pesquisa Clínica S/S	Curitiba	Parana
Brazil	Hospital São Vicente de Paulo	Passo Fundo	Rio Grande Do Sul
Brazil	Instituto Brasil de Pesquisa Clinica	Rio de Janeiro
Brazil	Cárdio Pulmonar da Bahia	Salvador	Bahia
Brazil	CIP Centro Integrado de Pesquisas do Hospital de Base	São José do Rio Preto	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Brazil	Departamento de Gastroenterologia - HCFMUSP	São Paulo	Sao Paulo
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo	Sao Paulo
Brazil	Instituto do Coração - HCFMUSP	São Paulo	Sao Paulo
Brazil	Eurolatino Medical Research Center	Uberlândia	Minas Gerais
Bulgaria	Medical Centre Diamedical-2013	Dimitrovgrad
Bulgaria	MHAT Lukovit, Department of Internal Diseases	Lukovit
Bulgaria	"MHAT - Pazardzhik" AD, Second Department of Internal Diseas	Pazardzhik
Bulgaria	"UMBAL-Dr. Georgi Stranski" EAD, First Clinic of cardiology	Pleven
Bulgaria	"UMHAT "Sveti Georgi" EAD	Plovdiv
Bulgaria	Medical centre Razgrad OOD	Razgrad
Bulgaria	"Acibadem City Clinic MHAT Tokuda" EAD,Cardiology department	Sofia
Bulgaria	"Acibadem City Clinic UMHAT" EOOD, Sofia, Cardiology clinic	Sofia
Bulgaria	"Diagnostic - Consulting Center Aleksandrovska" EOOD	Sofia
Bulgaria	"MHAT "NCH" EAD, Cardiology clinic, Noninvasive diag. dep.	Sofia
Bulgaria	"MHAT "NCH" EAD, Clinic of Cardiology, Depart. of Cardiology	Sofia
Bulgaria	"UMHAT "Aleksandrovska" EAD, Cardiology clinic	Sofia
Bulgaria	"UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology	Sofia
Bulgaria	"UMHAT "Tsaritsa Yoanna-ISUL"" EAD, Clinic of Cardiology	Sofia
Bulgaria	"UMHATEM N.I. Pirogov" EAD	Sofia
Bulgaria	"Diagnostic - Consulting Center "Ekvita"" EOOD	Varna
Canada	ViaCar Recherche Clinique Inc	Brossard	Quebec
Canada	Manna Research Inc. (Burlington N)	Burlington	Ontario
Canada	C-endo Diab Endo Clin Calgery	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	Manna Research Quebec	Levis	Quebec
Canada	St. Joseph's Health Care	London	Ontario
Canada	Manna Research Mirabel	Mirabel	Quebec
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Applied Med Inf Res	Montreal	Quebec
Canada	Clinique Sante Cardio MC	Montreal	Quebec
Canada	IRCM	Montreal	Quebec
Canada	Manna Research Ottawa	Nepean	Ontario
Canada	North York Diagn & Cardiac Ctr	North York	Ontario
Canada	Dr. James Cha	Oshawa	Ontario
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	Centricity Res Pointe-Claire	Pointe-Claire	Quebec
Canada	Medical Associates of Port Perry	Port Perry	Ontario
Canada	Institut universitaire de cardiologie	Quebec
Canada	Clin des Mal Lipid de Quebec	Québec	Quebec
Canada	HHI Research Inc.	Scarborough	Ontario
Canada	Centre de recherché du CHUS	Sherbrooke	Quebec
Canada	Synergy Wellness Clinic	Sherwood Park	Alberta
Canada	Ctr Méd. et pro d l'Ost d port	St-Marc-des-Carrières	Quebec
Canada	Manna Research Stoney Creek	Stoney Creek	Ontario
Canada	Centre de santé et de services	Terrebonne	Quebec
Canada	The Port Arthur Clinic Research Program	Thunder Bay	Ontario
Canada	Manna Research Inc._Toronto	Toronto	Ontario
Colombia	Clinica de la Costa	Barranquilla
Colombia	Fundacion del Caribe para la Investigacion Biomedica-BIOS	Barranquilla
Colombia	IPS Centro Cientifico Asistencial Jose Luis Accini SAS	Barranquilla	Atlántico
Colombia	Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia	Bucaramanga-piedecuesta, Valle Del Menzuli - Santander	Santander
Colombia	CardiovidCentro Cardiovascular Colombiano ClinicaSantaMaria	Medellin
Colombia	Centro de Investigacion Clinica Avanzada y Multidisciplinari	Medellin
Colombia	Rodrigo Botero S.A.S	Medellin	Antioquia
Croatia	Specijalna bolnica Krapinske Toplice - Kardiologija	Krapinske Toplice	Krapinsko Zagorska County
Croatia	Klinicki bolnicki centar Osijek	Osijek
Croatia	KBC Rijeka, Zavod za kardiomiopatije	Rijeka
Croatia	KBC "Sestre milosrdnice", Kardiologija	Zagreb
Croatia	KBC Zagreb, Klinika za bolesti srca i krvnih zila	Zagreb
Croatia	Klinicka bolnica Sveti Duh	Zagreb
Croatia	Poliklinika Solmed	Zagreb	Grad Zagreb
Czechia	Edumed Broumov	Broumov
Czechia	Ordinace pro choroby srdce	Chomutov
Czechia	Fakultni nemocnice Hradec Kralove_Hradec Kralove_0	Hradec Kralove
Czechia	Nemocnice Jihlava Kardiologie	Jihlava
Czechia	Kardiologické centrum	Liberec
Czechia	Policska nemocnice	Policka
Czechia	Fakultni poliklinika	Praha 2	Czech Republic
Czechia	Endocare	Praha 4
Czechia	ResTrial	Praha 8
Czechia	Nemocnice Slany Kardiologie	Slany
Czechia	Svitavska nemocnice Kardiologie	Svitavy
Czechia	Vseobecna kardiologicka ambulance	Tabor
Denmark	Aalborg Universitetshospital Kardiologisk Afdeling	Aalborg
Denmark	Aarhus Universitetshospital, Skejby Hjertesygdomme	Aarhus N
Denmark	Herlev og Gentofte Hospital	Hellerup	Region Hovedstaden
Denmark	Regionshospitalet Gødstrup, Hjertesygdomme	Herning
Denmark	Hvidovre Hospital Hjertemedicinsk	Hvidovre
Denmark	Kardiologisk Odense & Svendborg	Svendborg
Finland	StudyCor	Jyväskylä
Finland	Health Step Finland Oy	Kuopio
Finland	Päijät-Häme Central Hospital	Lahti
Finland	OYS Sisätautien tutkimusyksikkö	Oulu
Finland	Seinäjoen keskussairaala	Seinäjoki
Finland	TAYS Sydänsairaala	Tampere
Finland	TYKS Sydänkeskus	Turku
France	CHRU Besançon	Besançon
France	Hôpital Jean Verdier	Bondy
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes
France	Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage	DIJON cedex
France	Chu Du Bocage	DIJON cedex
France	Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1	La Tronche
France	Les Hopitaux de Chartres-Hopital Louis Pasteur	Le Coudray
France	Centre Hospitalier de Narbonne	Narbonne
France	CHU de Nice	Nice
France	Ap-Hp-Hopital Europeen Georges Pompidou	Paris
France	Aphp-Hopital La Pitie Salpetriere-2	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Ap-Hp-Hopital Bichat-Claude Bernard-2	Paris Cedex 18
France	Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2	Pessac
France	Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1	Saint Herblain
France	Les Hopitaux Universitaires de Strasbourg-Hopital Civil-2	Strasbourg
France	Groupe Hospitalier Mutualiste Des Portes Du Sud	Venissieux
Germany	Universitaetsklinikum Aachen AöR	Aachen
Germany	Kardiologische Praxis	Bad Homburg
Germany	Emovis GmbH	Berlin
Germany	Klinische Forschung Berlin (kfgn)	Berlin
Germany	Synexus Berlin	Berlin
Germany	Synexus Bochum	Bochum
Germany	Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH	Dresden
Germany	Klinische Forschung Dresden	Dresden
Germany	Zentrum fuer klinische Studien Suedbrandenburg GmbH	Elsterwerda
Germany	InnoDiab Forschung GmbH	Essen
Germany	MVZ CCB Frankfurt Und Main-Taunus GbR	Frankfurt
Germany	Synexus Frankfurt	Frankfurt
Germany	Denger, Friedrichsthal	Friedrichsthal
Germany	Klinische Forschung Hamburg	Hamburg
Germany	Wendisch/Dahl Hamburg	Hamburg
Germany	Klinische Forschung Hannover	Hannover
Germany	Chevts	Karlsruhe
Germany	Appel	Kassel
Germany	AmBeNet GmbH	Leipzig
Germany	Universitätsklinikum Leipzig, Endokrinologie und Nephrologie	Leipzig
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Die Praxis am Ludwigsplatz	Ludwigshafen
Germany	RED-Institut für medizinische Forschung und Fortbildung GmbH	Oldenburg in Holstein
Germany	Dr. Axthelm Christoph, Pirna	Pirna
Germany	Zentrum für klinische Studien Alexander Segner	Saint Ingbert-Oberwürzbach
Germany	Steindorf, Schkeuditz	Schkeuditz
Germany	Klinische Forschung Schwerin	Schwerin
Germany	Jacob, Villingen-Schwenningen	Villingen-Schwenningen
Germany	Zentrum für klinische Studien Allgäu Oberschwaben	Wangen
Germany	Al-Zoebi	Wermsdorf
Germany	Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann	Witten
Greece	"Hygeia" General Hospital of Athens	Athens
Greece	"Laiko" General Hospital of Athens	Athens
Greece	Alexandra General Hospital, Therapeutic Clinic	Athens
Greece	Hippokration Hospital	Athens
Greece	Iatriko Athinon (Athens Medical Canter)	Athens
Greece	Konstantopouleio G.H. of Athens, "Agia Olga"	Athens
Greece	Onassis Cardiac Surgery Center	Athens
Greece	General Hospital of Chios "Skilitsio"	Chios
Greece	University Hospital of Athens ATTIKON	Haidari-Athens
Greece	University General Hospital of Ioannina,Internal Medicine	Ioannina
Greece	General Hospital of Lamia	Lamia
Greece	Univ Gen Hospital Larisa, Internal Medicine Clinic	Larissa
Greece	"Thermi" Private Hosital	Thessaloniki
Greece	AHEPA General University Hospital	Thessaloniki
Hungary	Lausmed Kft.	Baja	Bács-Kiskun Vármegye
Hungary	Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika	Debrecen
Hungary	Bugát Pál Kórház	Gyöngyös
Hungary	Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ	Szeged	Csongrád-Csanád
Hungary	Markusovszky Egyetemi Oktatókórház	Szombathely
Hungary	Léda Platán Magánklinika	Zalaegerszeg	Zala Megye
India	Apex Heart Institute	Ahmedabad	Gujarat
India	CIMS- Care Institute of Medical Sciences	Ahmedabad	Gujarat
India	Kamalnayan Bajaj Hospital	Aurangabad	Maharashtra
India	Narayana Hrudayalya Institute of Cardiac Sciences	Bangalore
India	Sri Jayadeva Institute of Cardiovascular Sciences & Research	Bangalore	Karnataka
India	St John's Medical College and Hospital	Bangalore
India	St John's Medical College Hospital	Bengaluru	Karnataka
India	SP Medical College	Bikaner	Rajasthan
India	The Madras Medical Mission	Chennai	Tamil Nadu
India	G Kuppuswamy Naidu Memorial Hospital	Coimbatore	Tamil Nadu
India	Maulana Azad Medical College	Delhi	New Delhi
India	Medanta - The Medicity Multi-Speciality Hospital, Gurugram	Gurgaon	Haryana
India	Guru Nanak CARE Hospitals	Hyderabad	Telangana
India	Osmania General Hospital	Hyderabad	Telengana
India	B M Birla Heart Research Centre	Kolkata	West Bengal
India	Gandhi Memorial Hospital- King George's Medical University	Lucknow	Uttar Pradesh
India	Dayanand Medical College & Hospital	Ludhiana	Punjab
India	Department of Medicine - Kasturba Hospital	Manipal	Karnataka
India	Holy Family Hospital and Medical Research Centre	Mumbai	Maharashtra
India	Lokmanya Tilak Municipal Medical College & General Hospital	Mumbai	Maharashtra
India	Seth GS medical college and KEM Hospital	Mumbai	Maharashtra
India	Arneja Heart & Multispeciality Hospital	Nagpur	Maharashtra
India	Shri Krishna Hrudayalaya & Critical Care Centre	Nagpur	Maharashtra
India	Vijan Hospital & Research Centre	Nashik	Maharashtra
India	All India Institute of Medical Sciences	New Dehli	New Delhi
India	VMMC & Safdarjung Hospital	New Dehli	New Delhi
India	Batra Hospital and Medical Research Center	New Delhi	Delhi
India	Dr. BL Kapur Memorial Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
India	Grant Medical Foundation	Pune	Maharashtra
India	Nirmal Hospital Pvt. Ltd.	Surat	Gujarat
India	Shri B. D. Mehta Mahavir Heart Institute	Surat	Gujarat
India	Unicare heart institute and research centre	Surat	Gujarat
India	Christian Medical College Hospital, Vellore	Vellore	Tamil Nadu
India	Ramesh Hospitals	Vijayawada	Andhra Pradesh
Ireland	Connolly Hospital	Dublin	Leinster
Ireland	Mater Miscericordiae Hospital	Dublin	Leinster
Ireland	St Vincent's Private Hospital	Dublin
Ireland	Tallaght Hospital - Cardiology	Dublin
Ireland	The Heartbeat Trust	Dublin
Ireland	Mallow Primary Healthcare Centre	Mallow
Israel	Outpatient Diabetes Clinic Soroka MC	Beer Sheva
Israel	Diabetes and obesity center of excellence, Rambam MC	Haifa
Israel	Diabetes Unit Hadassah Ein Karem MC	Jerusalem
Israel	Hadassah Ein Kerem MC - Cardio	Jerusalem
Israel	Clinical Research Unit Meir Medical Center	Kfar Saba
Israel	Institute of Diabetes, Western Galilee MC Nahariya	Nahariya
Israel	Rabin Medical Center - Hasharon Hospital, Dept. D	Petah-Tikva
Israel	Kaplan MC	Rehovot
Israel	Cardio Vascular Research Center Sourasky MC	Tel Aviv
Israel	Endrocrinolgy Clinic - Sheba Medical Center	Tel Hashomer
Israel	Sheba Medica Center - Clinical Research Unit	Tel Hashomer
Israel	Institute of Endocrinology, metabolism and hypertension	Tel-Aviv
Italy	AO Papa Giovanni XXIII USS Dietologia Clinica	Bergamo
Italy	A. O. Universitaria S.ORSOLA-MALPIGHI - U. O. Endocrinologia	Bologna
Italy	ARNAS Ospedale Garibaldi	Catania
Italy	Università degli studi G. D'Annunzio Chieti Pescara - CAST	Chieti Scalo
Italy	Ospedale di San Fermo della Battaglia	Como
Italy	Azienda Osp-Univ Ferrara-Dip Scienze Mediche-Endocrinologia	Cona - Ferrara
Italy	AOU Careggi Dipartimento Medico Geriatrico SOD Diabetologia	Firenze
Italy	U.O.D. Dietetica e Nutrizione Clinica	Genova
Italy	Ospedale Santa Maria Goretti - UOD Diabetologia	Latina	LT
Italy	Azienda Ospedaliera Universitaria Federico II di Napoli	Napoli
Italy	Azienda Ospedaliera di Padova Clin.Med.3	Padova
Italy	Unità Funzionale di nutrizione clinica cod 58.01.3	Palermo
Italy	IRCCS Fondazione "S. Maugeri" U.O. Medicina Interna ed Endo	Pavia
Italy	Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello	Pisa
Italy	Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia	Roma	RM
Italy	UOC di Medicina Interna - Centro Medico dell'Obesità	Roma
Italy	Policlinico Universitario AGemelli DH Patologie dell'Obesità	Rome
Italy	Ist.Clinico Humanitas Endocrinologia e Malattie del ricambio	Rozzano (MI)
Italy	Centro di Alta Spec. Diet., Educ. Alim. e Prev. Cardio Metab	San Donato Milanese (MI)
Italy	Centro di Alta Spec. Diet., Educ. Alim. e Prev. Cardio Metab	San Donato Milanese (MI)	MI
Italy	Osp. Santissima Annunziata ASL CN1 Endocrinol. Diabetol.	Savigliano (CN)
Italy	IRCCS Multimedica	Sesto San Giovanni (MI)
Italy	A.O.U. Senese Policlinico "Le Scotte" , U.O.C. Diabetologia	Siena
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino
Japan	Seiwa Clinic	Adachi-ku, Tokyo
Japan	Toyooka Chuo Hospital	Asahikawa, Hokkaido
Japan	The Univ. of Tokyo Hp., Dept. of Cardiovascular Medicine	Bunkyo-ku, Tokyo
Japan	New Tokyo Heart Clinic_Matsudo-shi, Chiba,	Chiba
Japan	Fukuokaken Saiseikai Futsukaichi Hospital_Cardiovascular Medicine	Chikushino-shi, Fukuoka
Japan	Ehime Prefectural Central Hospital	Ehime
Japan	Chiba Tokushukai Hospital	Funabashi-shi, Chiba
Japan	Gifu Heart Center	Gifu-city, Gifu
Japan	Hirakata Kohsai Hospital	Hirakata-shi, Osaka
Japan	Medical Corporation JR Hiroshima Hospital	Hiroshima-shi, Hiroshima
Japan	Hiroshi Yamaguchi Clinic	Kagoshima-shi, Kagoshima
Japan	H.E.C Science Clinic	Kanagawa
Japan	Kasugai Municipal Hospital	Kasugai-shi, Aichi
Japan	Sugiura Clinic	Kawaguchi-shi, Saitama
Japan	Steel Memorial Yawata Hospital	Kitakyushu-shi, Fukuoka
Japan	Chikamori Hospital	Kochi-shi, Kochi
Japan	Saiseikai Kumamoto Hospital	Kumamoto-shi, Kumamoto
Japan	Uji Tokushukai Medical Center	Kyoto
Japan	Koseikai Takeda Hospital	Kyoto-shi, Kyoto
Japan	Ijinkai Takeda General Hospital, Cardiovascular Medicine	Kyoto-shi,Kyoto
Japan	Ijinkai Takeda General Hospital, Neurosurgery	Kyoto-shi,Kyoto
Japan	Medical Corporation Matsuyama-heartcenter Yotsuba Circulatio	Matsuyama-shi, Ehime
Japan	Shinden Higashi Clinic_Miyagi	Miyagi
Japan	Shiga General Hospital	Moriyama-shi, Shiga
Japan	Nagoya Ekisaikai Hospital	Nagoya-shi, Aichi
Japan	Naha City Hospital	Naha-shi, Okinawa
Japan	Takagi hospital, Internal Medicine	Okawa-shi, Fukuoka
Japan	Okayama Medical Center	Okayama-shi, Okayama
Japan	Takatsuki Red Cross Hospital	Osaka
Japan	Specified Med.Corp.Watanabeigakukai Sakurabashi Watanabe Hp.	Osaka-city, Osaka
Japan	Saga University Hospital, Department of Cardiology	Saga-shi, Saga
Japan	Hanaoka Seishu Memorial Hospital	Sapporo-shi, Hokkaido
Japan	Medical corporation Sanseikai Miyanomori Memorial Hospital	Sapporo-shi, Hokkaido
Japan	Shinsapporo Seiryou Hospital, Intenal Medicine	Sapporo-shi, Hokkaido
Japan	Sendai Kousei Hospital_Sendai-shi, Miyagi	Sendai-shi, Miyagi
Japan	National Center for Global Health and Medicine	Shinjuku-ku, Tokyo
Japan	Japan Community Health care Organization Ritsurin Hospital	Takamatsu-shi, Kagawa
Japan	Kagawa Prefectural Central Hospital	Takamatsu-shi, Kagawa
Japan	Kagawa Prefectural Central Hospital, Cardiovascular Medicine	Takamatsu-shi, Kagawa
Japan	Kan-etsu chu-oh Hospital	Takasaki-shi, Gunma
Japan	Tokorozawa Heart Center	Tokorozawa-shi, Saitama
Japan	Saino Clinic	Tokorozawa-shi,Saitama
Japan	Fukuwa Clinic	Tokyo
Japan	Minamino Cardiovascular Hospital	Tokyo
Japan	Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	National Hospital Organization Saitama National Hospital	Wako-city, Saitama
Japan	Nagata Hospital	Yanagawa-shi, Fukuoka
Japan	Yokosuka General Hospital Uwamachi, Cardiology	Yokosuka-shi, Kanagawa
Latvia	Ari Med	Daugavpils
Latvia	Meissana Ltd	Liepaja
Latvia	Teterovska practice	Ogre
Latvia	Adoria	Riga
Latvia	Health Centre-4	Riga
Latvia	Medical Centre Pulss 5	Riga
Latvia	Stradini Cardiology	Riga
Latvia	Ziemelkurzeme Regional Hospital	Ventspils
Malaysia	Klinik Kesihatan Masjid Tanah	Alor Gajah
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu	Kelantan
Malaysia	Sarawak Heart Centre	Kota Samarahan
Malaysia	Sarawak Heart Centre	Kota Samarahan	Sarawak
Malaysia	National Heart Institute	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	Hospital Putrajaya	Putrajaya
Malaysia	Hospital Queen Elizabeth II	Sabah
Malaysia	Hospital Seri Manjung	Seri Manjung	Perak
Malaysia	University Technology MARA (UiTM) - Puncak Alam	Sungai Buloh	Selangor
Mexico	Centro de Investigación Cardiometabólica de Aguascalientes	Aguascalientes
Mexico	Hospital General Regional 1 "Dr. Carlos Mac Gregor Sánchez"	Ciudad de Mexico	México, D.F.
Mexico	Instituto Nacional de Cardiología Ignacio Chavez	Ciudad de Mexico	México, D.F.
Mexico	Centro para el Desarrollo de la Medicina y la Asistencia	Culiacán	Sinaloa
Mexico	Lahoja Asociación para la Investigación y Farmacovigilancia	Durango
Mexico	Centro de Investigacion Clinica Endocrinologica de Jalisco	Guadalajara	Jalisco
Mexico	Hospital Universitario Dr. José Eleuterio González_Monterrey	Monterrey	Nuevo León
Mexico	Unidad Biomedica Avanzada Monterrey	Monterrey	Nuevo León
Mexico	Centro de atención e investigación cardiovascular del Potosí	San Luis Potosí	San Luis Potosi
Mexico	CIMAB SA de CV	Torreon	Coahuila
Netherlands	Gelre Ziekenhuizen Apeldoorn	Apeldoorn
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	UMC Groningen	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Alrijne Leiderdorp	Leiderdorp
Netherlands	Bravis Ziekenhuis	Roosendaal
Netherlands	Franciscus Gasthuis en Vlietland	Rotterdam
Netherlands	D & A Research B.V.	Sneek
Netherlands	Ziekenhuis Rivierenland Tiel	Tiel
Norway	Ålesund Sjukehus - Hjertemedisinsk poliklinikk	Ålesund
Norway	Haukeland Universitetssykehus	Bergen
Norway	Falck Norge AS	Hamar
Norway	Sykehuset Innlandet Lillehammer	Lillehammer
Norway	Akershus Universitetssykehus	Nordbyhagen
Norway	Oslo universitetssykehus Aker	Oslo
Norway	Oslo universitetssykehus HF Ullevål	Oslo
Norway	Rikshospitalet - Kardiologisk forskning	Oslo
Norway	Senter for sykelig overvekt i Helse Sør-Øst	Tønsberg
Poland	Gabinet Leczenia Otylosci i Chorob Dietozaleznych	Bialystok	Podlaskie Voivodeship
Poland	Kresmed Sp. z o. o.	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych PI-House	Gdansk
Poland	Poradnia Kardiologiczna Jaroslaw Jurowiecki	Gdansk
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	PRATIA Centrum Medyczne	Gdynia	Pomorskie
Poland	Grazyna Pulka Specjalistyczny Osrodek "All-Med"	Krakow
Poland	UniCardia & UniMedica & UniEstetica	Krakow
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Klimed Lomza	Lomza
Poland	ETG Lowicz	Lowicz
Poland	NZOZ "CenterMed Lublin" Sp. z o.o.	Lublin	Lubelskie
Poland	Centrum Medyczne HCP Sp. z o.o.	Poznan
Poland	Centrum Zdrowia Metabolicznego	Poznan	Wielkopolskie Voivodeship
Poland	KO-MED Centra Kliniczne Sp. z o.o.	Pulawy
Poland	ETG Siedlce	Siedlce	Masovian
Poland	Clinmedica Research sp. z o.o.	Skierniewice	Lodzkie
Poland	Gabinety Lekarskie LabMed	Szczecin
Poland	ETG Warszawa	Warsaw	Masovian
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji	Warszawa
Poland	Przychodnia Lekarzy Specjalistow Serce	Warszawa
Poland	Ko-Med Nova Sp.zo.o. oddzial w Zamosciu	Zamosc
Portugal	Hospital Garcia de Orta	Almada
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra
Portugal	Centro Hospitalar Lisboa Norte	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos
Portugal	Centro Hospitalar de São João	Porto
Puerto Rico	San Miguel Medical	Trujillo Alto
Romania	Minimed S.R.L.	Bacau
Romania	CMI Dr Pop Lavinia	Baia Mare	Maramures
Romania	Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed	Brasov
Romania	"Carol Davila" Military Emergency Hospital	Bucharest
Romania	Sana Monitoring SRL	Bucharest
Romania	SC Eco-Diagnosis SRL	Bucharest
Romania	Sc Nicodiab Srl	Bucharest
Romania	Institutul National de Endocrinologie C.I. Parhon	Bucuresti
Romania	S.C. Medcon S.R.L	Buzau
Romania	SC Ames Research Center SRL	Clarasi	Calaras
Romania	S.C. Centrul Medical Unirea S.R.L.	Cluj Napoca	Cluj
Romania	S.C. Top Diabet Srl	Craiova	Dolj
Romania	County Hospital Deva	Deva	Hunedoara
Romania	S.C Milena Sante SRL	Galati
Romania	SC Diamed Obesity SRL	Galati
Romania	SC Cardiomed SRL	Iasi
Romania	SC Consultmed SRL	Iasi
Romania	S.C. Endodigest S.R.L.	Oradea	Bihor
Romania	SC Grand Med SRL	Oradea	Bihor
Romania	Bella Praxis S.R.L.	Pascani
Romania	Centrul Medical Bella Praxis	Pascani
Romania	S.C. Dianutrilife Medica S.R.L.	Ploiesti
Romania	County Emergency Hospital Satu Mare	Satu Mare
Romania	SC Gensan SRL, Policlinica ASTRA	Sibiu
Romania	Sc Mediab Srl	Targu Mures	Mures
Romania	3rd Clinic for Nutrition-Spitalulul Jude?ean de Urgenta	Timisoara	Timis
Russian Federation	Volosevich First City Clinical Hospital	Arkhangelsk
Russian Federation	City Hospital #5	Barnaul
Russian Federation	RBSHI "Altay Regional Cardiology Dispensary"	Barnaul
Russian Federation	Reg. State Budget Healthc. Inst. Regional Clinical Hospital	Barnaul
Russian Federation	Belgorod regional clinical hospital of the St. Ioasaph	Belgorod
Russian Federation	Urals State Medical University	Ekaterinburg
Russian Federation	Cardiological dispensary	Ivanovo
Russian Federation	KSFMU, Inrereginal Clinical Diagnostic center	Kazan
Russian Federation	Institute of Complex Problems of Cardio-Vascular Diseases	Kemerovo
Russian Federation	City Clinical Hospital ?52	Moscow
Russian Federation	Federal Bureau for Medical and Social Expertise	Moscow
Russian Federation	Friendship University of Russia	Moscow
Russian Federation	Medical Center CAPITAL-HEALTH	Moscow
Russian Federation	Moscow City Clinical Hospital #15	Moscow
Russian Federation	Moscow City Clinical Hospital n.a. A.K. Eramishantseva	Moscow
Russian Federation	Moscow State University n.a. M.V. Lomonosov	Moscow
Russian Federation	National Medical Research Center of Cardiology	Moscow
Russian Federation	PHI "Central Clinical Hospital RZD- Medicine"	Moscow
Russian Federation	Limited Law Company "Healthy Family" Medicine Center"	Novosibirsk
Russian Federation	LLC RC Medical	Novosibirsk
Russian Federation	LLC Reafan	Novosibirsk
Russian Federation	Scientific Research Institute of neuroscience and Medicine	Novosibirsk
Russian Federation	Orenburg Regional Clinical Hospital	Orenburg
Russian Federation	Penza Regional Clinical Hospital named after N.N. Burdenko	Penza
Russian Federation	Rostov State Medical University_Rostov-on-Don	Rostov-on-Don
Russian Federation	SPb SBHI City Outpatient clinic #109	Saint Petersburg
Russian Federation	Astarta Clinic LLC	Saint-Petersburg
Russian Federation	City policlinic #28	Saint-Petersburg
Russian Federation	Consultative & Diagnostic Center with a Outpatient Hospital	Saint-Petersburg
Russian Federation	FSPbSMU n.a. Academic I.P. Pavlov	Saint-Petersburg
Russian Federation	Joint Stock Company "Modern Medical Technologies"	Saint-Petersburg
Russian Federation	Limited Liability Company "Energiya Zdoroviya"	Saint-Petersburg
Russian Federation	Saint-Petersburg "City Policlinic # 74"	Saint-Petersburg
Russian Federation	SPb SBHI City Outpatient clinic #37	Saint-Petersburg
Russian Federation	SPb SBHI City polyclinic #117	Saint-Petersburg
Russian Federation	SPb SBHI City Hospital #38 n.a. N.A. Semashko	Saint-Petersburg, Pushkin
Russian Federation	Regional Clinical cardiological dispensary n.a. Polyakov	Samara
Russian Federation	City Hospital #4, Sochi	Sochi
Russian Federation	SPb SBHI City Multifield Hospital #2	St. Petersburg
Russian Federation	SAHI of Komi Republic "Consultative Diagnostic Center"	Syktyvkar
Russian Federation	Siberian State Medical University_Tomsk	Tomsk
Russian Federation	Tomsk National Research Medical Center of the RAS	Tomsk
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	Tumen State Medical University	Tumen	Russia
Russian Federation	Tumen State Medical University - RIMBB	Tumen
Russian Federation	Regional Clinical Hospital of Tver	Tver
Russian Federation	Ulianovsk Regional Clinical Hospital	Ulianovsk
Russian Federation	Voronezh Regional Clinical Consultive-diagnostic Centre	Voronezh
Russian Federation	Solovyov Clinical Emergency Hospital	Yaroslavl
Serbia	Clinical centre of Serbia, Clinic for cardiology	Belgrade
Serbia	Clinical Centre of Serbia, Emergency Centre, Department of Cardiology	Belgrade
Serbia	Emergency Internal Medicine Clinic	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Special Hospital "Sveti Sava"	Belgrade
Serbia	Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.	Novi Sad	Vojvodina
South Africa	Cardiology Clinical Research	Alberton	Gauteng
South Africa	Cardiology Research_Bloemfontein	Bloemfontein	Free State
South Africa	IATROS International	Bloemfontein	Free State
South Africa	Josha Research	Bloemfontein	Free State
South Africa	Dr Corbett	Cape Town	Western Cape
South Africa	Dr S Dawood	Cape Town	Western Cape
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape
South Africa	Tread Research (Pty)Ltd	Cape Town	Western Cape
South Africa	UCT Lung institute	Cape Town	Western Cape
South Africa	Dr Iftikhar Osman Ebrahim	Centurion	Gauteng
South Africa	Dr Jugnundan's Rooms	Durban	KwaZulu-Natal
South Africa	CRISMO	Germiston	Gauteng
South Africa	Tickerdoc Research (Pty) LTD	Johannesburg	Gauteng
South Africa	Wits Bara Clinical Trial Site	Johannesburg	Gauteng
South Africa	WITS Clinical Research	Johannesburg	Gauteng
South Africa	Cape Town Medical Research Centre	Kuilsriver	Western Cape
South Africa	Dr Moosa's Rooms	Lenasia	Gauteng
South Africa	Lenasia Clinical Trial Centre	Lenasia	Gauteng
South Africa	Paarl Research Centre	Paarl	Western Cape
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	Clinical Trial Systems (CTC)	Pretoria	Gauteng
South Africa	Jongaie Research	Pretoria	Gauteng
South Africa	Synexus Watermeyer Clinical Research Centre	Pretoria	Gauteng
South Africa	Roodepoort Medicross Clinical Research Centre	Roodepoort	Gauteng
South Africa	Clinical Projects Research	Worcester	Western Cape
Spain	Centro Periférico de Especialidades Bola Azul	Almeria
Spain	Complejo Hospitalario Universitario A Coruña	La Coruña
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Clínico Virgen de la Victoria	Málaga
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Clínica Nuevas Tecnologías en Diabetes y Endocrinología	Sevilla
Spain	Hospital Infanta Luisa	Sevilla
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospital La Fe - Endocrinología y Nutrición	Valencia
Sweden	Lundberglab for Diab Research	Göteborg
Sweden	Centralsjukhuset, Kristianstad	Kristianstad
Sweden	Clemenstorgets Hjärtmottagning	Lund
Sweden	Enheten för Kliniska Studier (EKS), Örebro	Örebro
Sweden	Hjärtenheten	Östersund
Sweden	Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl	Stockholm
Taiwan	HsinChu MacKay Memorial Hospital	Hsinchu City
Taiwan	E-DA Hosiptal	Kaohsiung City
Taiwan	MacKay Memorial Hospital-Tamsui Branch	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital Linkou	Taoyuan City
Thailand	King Chulalongkorn Memorial Hospital_Bangkok	Bangkok
Thailand	Phramongkutklao Hospital-cardio	Bangkok
Thailand	Phramongkutklao Hospital-neuro	Bangkok
Thailand	Ramathibodi Hospital-Cardiovascular metabolic Center	Bangkok
Thailand	Siriraj Hospital_Bangkok_1	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai	Mueang Chiang Mai District
Thailand	Maharaj Nakorn Chiang Mai Hospital-cardio	Chiang Mai
Thailand	Srinakarind Hospital-Division of Cardiology	Khon kaen
Thailand	Thammasat University Hospital	Klong Luang, Pathumthani	Pathumthani
Turkey	Baskent Universitesi Adana	Adana
Turkey	Cukurova University School of Medicine Balcali Hospital	Adana
Turkey	Gulhane Egitim Arastirma Hastanesi	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Akdeniz University Tip Fakultesi Hastanesi	Antalya
Turkey	Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi	Aydin
Turkey	Eskisehir Osmangazi University-Cardio	Eskisehir
Turkey	Gaziantep Universitesi Tip Fakultesi Hastanesi	Gaziantep
Turkey	Fatih Sultan Mehmet Hastanesi	Istanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji	Istanbul
Turkey	Koc University Hospital	Istanbul
Turkey	Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi	Istanbul
Turkey	T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi	Istanbul
Turkey	TC SB Ist.Il Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi	Istanbul
Turkey	Umraniye Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Dokuz Eylul University School of Medicine, Cardiology	Izmir
Turkey	Ege University School of Medicine, Cardiology Department	Izmir
Turkey	Izmir Tepecik Training and Research Hospital	Izmir
Turkey	Erciyes University Cardiology	Kayseri
Turkey	Mersin University Cardiology	Mersin
Turkey	Cumhuriyet University School of Medicine-Cardiology	Sivas
Ukraine	CMI City Clinical Hospital #3	Chernivtsi
Ukraine	CNPI "Kharkiv City Clinical Hospital #27"	Kharkiv
Ukraine	NI of Therapy na LT Malaya of NAMSU - Chr. Non-Communicable	Kharkiv
Ukraine	Clinical Hosp on the railway line ?2 branch PHC JSC Ukrzaliz	Kyiv
Ukraine	Kyiv City Clinical Hospital of Emergency Care - Infarction	Kyiv
Ukraine	Kyiv Regional Hospital	Kyiv
Ukraine	MD Strazheska Institute of Cardiology of NAMSU - Resuscitati	Kyiv
Ukraine	Medical Center 'Ok!Clinic+' of II of Clinical Studies LLC	Kyiv
Ukraine	Medical Center of LLC 'Harmoniya Krasy'	Kyiv
Ukraine	Oleksandrivska Clinical Hospital - cardio rehabilitation dep	Kyiv
Ukraine	City Clinical Emergency Hospital - Cardiology department	Lviv
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	Odessa Clinical Railway Hospital - Outpatient department	Odesa
Ukraine	City Clinical Hospital #1 - Therapy department	Vinnytsia
Ukraine	Vinnytsia Regional Clinical Hospital - Cardiology department	Vinnytsia
Ukraine	Central City Hospital #1 - Scientific-Research center	Zhytomyr
Ukraine	Zhytomir Regional Clinical Hospital - Cardio-Arrhytm. centre	Zhytomyr
United Kingdom	Crouch Oak Family Practice	Addlestone
United Kingdom	Stroke Trials Office	Airdrie
United Kingdom	Antrim Area Hospital	Antrim
United Kingdom	Axbridge & Wedmore Medical Practice	Axbridge
United Kingdom	Bermuda Practice	Basingstoke
United Kingdom	Sea Road Surgery	Bexhill-on-Sea
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Layton Medical Centre	Blackpool
United Kingdom	Bollington Medical Centre	Bollington
United Kingdom	The Health Centre	Bradford-on-Avon
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Ely Bridge Surgery	Cardiff
United Kingdom	St Peters Hospital, Chertsey	Chertsey
United Kingdom	Countess Of Chester NHS Foundation Trust	Chester
United Kingdom	St. Richards Hospital	Chichester	West Sussex
United Kingdom	WISDEM Centre	Coventry
United Kingdom	Kings College Hospital	Denmark Hill, London
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust	Exeter
United Kingdom	Harrogate District Hospital	Harrogate, North Yorkshire
United Kingdom	Department Of Cardiac Research	Harrow
United Kingdom	Wycombe General Hospital	High Wycombe
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Cardiology	Leicester
United Kingdom	Lincoln County Hospital	Lincoln
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Guys Hospital	London
United Kingdom	Imperial College London	London
United Kingdom	Diabetes Centre North Manchester General Hospital	Manchester
United Kingdom	Cardio Research	Middlesbrough
United Kingdom	University Dept of Medicine, Derriford Hospital, Plymouth	Plymouth
United Kingdom	Clarence Medical Centre	Rhyl
United Kingdom	Clifton Medical Centre	Rotherham	South Yorkshire
United Kingdom	Ashfields Primary Care Centre	Sandbach
United Kingdom	Clinical Research Unit	Somerset
United Kingdom	Moorgreen Hospital	Southampton
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Musgrove Park Hospital	Taunton
United Kingdom	Cardiology Department	Torquay
United Kingdom	Royal Cornwall Hospital (Treliske)	Truro
United Kingdom	University Hospital Wishaw	Wishaw
United States	Albany Medical College - Endo	Albany	New York
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Inova Cardiology - Mt. Vernon	Alexandria	Virginia
United States	Ellipsis Group	Alpharetta	Georgia
United States	Amarillo Med Spec LLP	Amarillo	Texas
United States	Community Clinical Research_Anderson	Anderson	Indiana
United States	Internal Medicine Associates of Anderson	Anderson	South Carolina
United States	Synexus Clin Res US-Anderson	Anderson	South Carolina
United States	Michigan Medicine	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Arlington Family Res. Ctr Inc	Arlington	Texas
United States	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois
United States	University of Colorado Hospital	Aurora	Colorado
United States	Texas Diab & Endo, P.A.	Austin	Texas
United States	American Health Network of Indiana, LLC_Avon_0	Avon	Indiana
United States	Ascension Saint Agnes Heart Ca	Baltimore	Maryland
United States	MedStar Good Samaritan Hosp	Baltimore	Maryland
United States	University Of Maryland School of Medicine	Baltimore	Maryland
United States	UT Health University of Texas	Bellaire	Texas
United States	Belzoni Clinical Research	Belzoni	Mississippi
United States	National Heart Institute Cal	Beverly Hills	California
United States	Central Alabama Research	Birmingham	Alabama
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	Excel Med Ctr Clinical Trials	Boca Raton	Florida
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Wade Family Medicine	Bountiful	Utah
United States	Bradenton Research Center	Bradenton	Florida
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Holston Medical Group Pc	Bristol	Tennessee
United States	Dr. Alexander Perkelvald	Brooklyn	New York
United States	Mercury Street Medical Group, PLLC_Butte	Butte	Montana
United States	ClinSite LLC.	Canton	Michigan
United States	UNC Eastowne Clinical Trials Unit	Chapel Hill	North Carolina
United States	Medical Uni of SC Charleston	Charleston	South Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Apex Medical Research Inc	Chicago	Illinois
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	The Carl & Edyth Lindner Center	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Cleveland Clinic_Cleveland	Cleveland	Ohio
United States	Optumcare Colorado Springs	Colorado Springs	Colorado
United States	Optumcare Colorado Springs, LLC	Colorado Springs	Colorado
United States	Johns Hopkins University	Columbia	Maryland
United States	Corvallis Clinic PC Clinical Research Department	Corvallis	Oregon
United States	FDRC	Costa Mesa	California
United States	Valley Clinical Trials	Covina	California
United States	Nature Coast Clin Rsrch_Crystal River	Crystal River	Florida
United States	Texas Health Physicians Group_Dallas	Dallas	Texas
United States	Thyroid, Endocrinology, and Diabetes, PA	Dallas	Texas
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Cardiology Consultants of Danville Inc.	Danville	Virginia
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Providence Health Partners Ctr	Dayton	Ohio
United States	Florida Premier Cardiology	Delray Beach	Florida
United States	Henry Ford Health System	Detroit	Michigan
United States	Doylestown Hospital Pharmacy	Doylestown	Pennsylvania
United States	Duke University_Durham	Durham	North Carolina
United States	Durham VA Medical Center - Duke University	Durham	North Carolina
United States	UniMed Center	East Brunswick	New Jersey
United States	Centennial Medical Group	Elkridge	Maryland
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Inova Cardiology-Fairfax	Fairfax	Virginia
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Northeast Research Institute	Fleming Island	Florida
United States	Aa Mrc Llc	Flint	Michigan
United States	Integrative Research Assoc Inc	Fort Lauderdale	Florida
United States	American Health Network of IN LLC_Franklin	Franklin	Indiana
United States	WakeMed Garner Hlthplx	Garner	North Carolina
United States	The Stern Cardiovascular Group	Germantown	Tennessee
United States	Macoupin Research Group	Gillespie	Illinois
United States	Synexus Clinical Research	Glendale	Arizona
United States	Synexus Clinical Research US, Inc./Tatum	Glendale	Arizona
United States	New West Physicians,Inc.	Golden	Colorado
United States	St. Vincent Hosp-Prevea Health	Green Bay	Wisconsin
United States	American Health Network of Indiana, LLC_Greenfield	Greenfield	Indiana
United States	Palmetto Clinical Research	Greenville	South Carolina
United States	Physician's East Endocrinology	Greenville	North Carolina
United States	Louisiana Heart Center	Hammond	Louisiana
United States	Harleysville Medical Associates	Harleysville	Pennsylvania
United States	Chicago Medical Research LLC	Hazel Crest	Illinois
United States	Synexus Clinical Research US	Henderson	Nevada
United States	Clinical Research of Hollywood_Hollywood	Hollywood	Florida
United States	Northwest Houston Cardiology, P.A.	Houston	Texas
United States	PlanIt Research, PLLC	Houston	Texas
United States	University of Iowa Prev Inter Ctr	Iowa City	Iowa
United States	Baptist Heart Specialists_Jacksonville	Jacksonville	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Est Cst Inst for Rsrch,Jksnvil	Jacksonville	Florida
United States	Jacksonville Ctr For Clin Res	Jacksonville	Florida
United States	Baptist Heart Specialists_Jacksonville Beach	Jacksonville Beach	Florida
United States	NSC Research, Inc	Johns Creek	Georgia
United States	Richard M Kastelic MD Assoc	Johnstown	Pennsylvania
United States	The University Of Kansas Medical Center - Cray Dia	Kansas City	Kansas
United States	Clinical Inv Spec, Inc.Kenosha	Kenosha	Wisconsin
United States	Holston Medical Group	Kingsport	Tennessee
United States	Scripps Whittier Diabetes Inst	La Jolla	California
United States	Long Island Cardiovascular Consultants PC	Lake Success	New York
United States	First Valley Medical Group	Lancaster	California
United States	Palm Research Center Inc-Vegas	Las Vegas	Nevada
United States	Torrance Clin Res Inst, Inc.	Lomita	California
United States	Long Beach VA healthcare System	Long Beach	California
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Angel City Research, Inc.	Los Angeles	California
United States	VAGLAHS Clinical Research Center (CRC)	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Norton Clinical Research Group	Louisville	Kentucky
United States	Robley Rex VA Medical Center	Louisville	Kentucky
United States	Duke University - S.E Cardio	Lumberton	North Carolina
United States	Advanced Med Res Maumee	Maumee	Ohio
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	International Research Associates, LLC_Miami	Miami	Florida
United States	Reyes Clinical Research, Inc	Miami	Florida
United States	Franciscan Health Michigan City	Michigan City	Indiana
United States	Virginia Research Center	Midlothian	Virginia
United States	Healthscan Clinical Trials,LLC.	Montgomery	Alabama
United States	Optumcare Colorado Springs, LLC_Monument	Monument	Colorado
United States	Riverside University Health System Medical Center	Moreno Valley	California
United States	Burke Primary Care	Morganton	North Carolina
United States	Accellacare US Inc._SC	Mount Pleasant	South Carolina
United States	American Health Network of IN LLC	Muncie	Indiana
United States	Southern NH Diabetes and Endo_Nashua	Nashua	New Hampshire
United States	InvestiClin Research	Nashville	Tennessee
United States	MidState Endocrine Associates	Nashville	Tennessee
United States	Barnum Medical Research, Inc.	Natchitoches	Louisiana
United States	American Health Network of Indiana, LLC	New Albany	Indiana
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Comprehensive Weight Ctrl Prog	New York	New York
United States	NYU Grossman School of Med	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Strelitz Diabetes Of Eastern V.	Norfolk	Virginia
United States	York Clinical Research LLC	Norfolk	Virginia
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Lemah Creek Clinical Research	Oakbrook Terrace	Illinois
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
United States	University of NE Med Ctr	Omaha	Nebraska
United States	VA NEB - Western IA Health Stm	Omaha	Nebraska
United States	AdventHealth Diab Inst	Orlando	Florida
United States	Midwest Heart & Vasc Spec	Overland Park	Kansas
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	MD Medical Research	Oxon Hill	Maryland
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Hospital of the Univ PA	Philadelphia	Pennsylvania
United States	Parkside Family Medicine	Philadelphia	Pennsylvania
United States	Tristar Clin Investigations, PC	Philadelphia	Pennsylvania
United States	Synexus Cln Rsrch /Cnt Phoenix Med C	Phoenix	Arizona
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Research Institute Of Dallas	Plano	Texas
United States	Western University of Health Sciences	Pomona	California
United States	Oregon Health & Science Uni	Portland	Oregon
United States	Quartz Hill Walk-in Medical Group, inc.	Quartz Hill	California
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Dominion Medical Associates	Richmond	Virginia
United States	National Clin Res Inc.	Richmond	Virginia
United States	Endo And Metab Cons	Rockville	Maryland
United States	Endocrine Research Solutions	Roswell	Georgia
United States	East Coast Institute for Research LLC	Saint Augustine	Florida
United States	Amicis Centers of Clinical Research	Saint Louis	Missouri
United States	St Louis Heart & Vascular, P.C.	Saint Louis	Missouri
United States	VA Medical Center_Salem	Salem	Virginia
United States	Audie L. Murphy Va Hospital, Stvhcs	San Antonio	Texas
United States	Physician PrimeCare Research Institute, PLLC dba	San Antonio	Texas
United States	Quality Research Inc	San Antonio	Texas
United States	San Antonio Prem Int Med	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	VIP Trials	San Antonio	Texas
United States	San Diego Family Care	San Diego	California
United States	TriWest Research Associates	San Diego	California
United States	Mills-Peninsula Medical Center	San Mateo	California
United States	NorCal Endocrinology and Internal Medicine	San Ramon	California
United States	Intercoastal Medical Group	Sarasota	Florida
United States	Saratoga Clinical Research	Saratoga Springs	New York
United States	Evanston Premier Hlthcr Res	Skokie	Illinois
United States	NorthShore Univ Hlth Sys	Skokie	Illinois
United States	Louisiana Heart Center_Slidell	Slidell	Louisiana
United States	U. of Vermont Med Ctr Burlington	South Burlington	Vermont
United States	Encompass Clinical Research_Spring Valley	Spring Valley	California
United States	Central Illinois Diabetes and Clinical Research	Springfield	Illinois
United States	Family Health Care Center	Statesboro	Georgia
United States	Houston Center for Clinical Research LLC	Sugar Land	Texas
United States	Simcare Medical Research, LLC	Sugar Land	Texas
United States	Herman Clinical Research LLC	Suwanee	Georgia
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cotton O'Neil Clin Research Ctr	Topeka	Kansas
United States	Lundquist Inst-Biomed Innovtn	Torrance	California
United States	Atlanta Heart Specialists, LLC	Tucker	Georgia
United States	Trinity Clinical Research LLC	Tullahoma	Tennessee
United States	Christus Heart and Vascular Institute	Tyler	Texas
United States	Velocity Clinical_Valparaiso	Valparaiso	Indiana
United States	Bayview Physician Services	Virginia Beach	Virginia
United States	Sentara Medical Group_Norfolk	Virginia Beach	Virginia
United States	Synexus Clinical Research US, Inc._Horsham	Vista	California
United States	Hillcrest Family Health Center	Waco	Texas
United States	New Venture Medical Research	Wadsworth	Ohio
United States	Chase Medical Research LLC	Waterbury	Connecticut
United States	Aspirus Research Institute	Wausau	Wisconsin
United States	Cardio Partners Clin Res Inst	Wellington	Florida
United States	Wenatchee Valley Hospital and Clinics	Wenatchee	Washington
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Kalo Clinical Research	West Valley City	Utah
United States	Great Lakes Medical Research	Westfield	New York
United States	Accellacare	Wilmington	North Carolina
United States	Amherst Family Practice P.C.	Winchester	Virginia
United States	Selma Medical Associates	Winchester	Virginia
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Trinity Health Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Latvia,  Malaysia,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (3)

Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Ou — View Citation

Ryan DH, Lingvay I, Colhoun HM, Deanfield J, Emerson SS, Kahn SE, Kushner RF, Marso S, Plutzky J, Brown-Frandsen K, Gronning MOL, Hovingh GK, Holst AG, Ravn H, Lincoff AM. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity — View Citation

Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke	Measured in months	0-59 months
Secondary	Time to CV death	Measured in months	0-59 months
Secondary	Time to all-cause death	Measured in months	0-59 months
Secondary	Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation	Measured in months	0-59 months
Secondary	Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death	Measured in months	0-59 months
Secondary	Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke	Measured in months	0-59 months
Secondary	Time to first occurrence of non-fatal myocardial infarction	Measured in months	0-59 months
Secondary	Time to first occurrence of non-fatal stroke	Measured in months	0-59 months
Secondary	Time to first occurrence of coronary revascularisation	Measured in months	0-59 months
Secondary	Time to first occurrence of unstable angina requiring hospitalisation	Measured in months	0-59 months
Secondary	Time to first occurrence of heart failure hospitalisation or urgent heart failure visit	Measured in months	0-59 months
Secondary	Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%)	Measured in months	0-59 months
Secondary	Time to first occurrence of a 5-component composite nephropathy endpoint	Measured in months. A 5-component composite nephropathy endpoint consists of: onset of persistent macroalbuminuria (UACR above 300 mg/g), persistent 50% reduction in estimated Glomerular Filtration Rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR less than 15 ml/min/1.73m^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death.	0-59 months
Secondary	Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%)	Measured in months	0-59 months
Secondary	Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%)	Proportion of subjects	0-59 months
Secondary	Change in systolic blood pressure	Measured in mm Hg	Week 0, year 2
Secondary	Change in diastolic blood pressure	Measured in mm Hg	Week 0, year 2
Secondary	Change in pulse	Measured in beats per minute	Week 0, year 2
Secondary	Change in High sensitivity C-Reactive Protein (hsCRP)	Measured in mg/dL	Week 0, year 2
Secondary	Change in total cholesterol	Measured in mg/dL	Week 0, year 2
Secondary	Change in high density lipoprotein (HDL) cholesterol	Measured in mg/dL	Week 0, year 2
Secondary	Change in low density lipoprotein (LDL) cholesterol	Measured in mg/dL	Week 0, year 2
Secondary	Change in triglycerides	Measured in mg/dL	Week 0, year 2
Secondary	Change in body weight	Measured in %	Week 0, year 2
Secondary	Change in waist circumference	Measured in cm	Week 0, year 2
Secondary	Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire	The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.	Week 0, year 2
Secondary	Change in total score weight related sign and symptom measure	The weight related sign and symptom measure assesses the presence and bother associated with weight-related symptoms using a self-rated VAS. It is a tool to assess the multifaceted aspects of obesity on symptom experience in subjects with overweight or obesity.	Week 0, year 2
Secondary	Change in haemoglobin A1c (HbA1c)	Measured in %	Screening (up to 3 weeks before randomisation at week 0), week 104
Secondary	Change in HbA1c	Measured in mmol/mol	Screening (up to 3 weeks before randomisation at week 0), week 104