Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

617

Participants

Timeline

Start Date

June 15, 2021

Primary Completion Date

October 11, 2023

Study Completion Date

October 11, 2023

Conditions
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
Interventions
DRUG

Semaglutide

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.

DRUG

Placebo (Semaglutide)

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.

Trial Locations (120)

1032

Szent Margit Rendelőintézet Nonprofit Kft., Budapest

1085

Semmelweis Egyetem Szent Rókus Klinikai Tömb, Budapest

1096

Gottsegen György Országos Kardiológiai Intézet, Budapest

1122

Semmelweis Egyetem Városmajori Szív- és Érgyógyászat, Budapest

1190

Imed 19- privat, Vienna

1204

Jahn Ferenc Dél-pesti Kórház és Rendelőintézet, Budapest

1425

Cardiología Palermo, Ciudad Autónoma de Buenos Aire

2921

Selye János Kórház, Komárom

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház, Miskolc

4032

DE KK Kardiológiai és Szívsebészeti klinika, Debrecen

5280

Krankenhaus St. Josef Braunau, Braunau am Inn

6500

Lausmed Kft., Baja

8036

Medizinische Universität Graz, Graz

8511

Fließer-Görzer [Ordination], Saint Stefan

8900

Zala Megyei Szent Rafael Kórház, Zalaegerszeg

13353

Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU), Berlin

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

20138

Centro Cardiologico Monzino, Milan

21287

John Hopkins Hospital, Baltimore

22100

Western Galilee MC - Cardiology Department, Nahariya

23298

Virginia Commonwealth University, Richmond

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

25123

Spedali Civili Brescia, Brescia

27157

Wake Forest Baptist Health, Winston-Salem

28557

Carteret Medical Group, Morehead City

32258

Baptist Heart Specialists_Jacksonville, Jacksonville

36532

Eastern Shore Rsrch Inst, LLC, Fairhope

39216

Univ of Mississippi Med Ctr, Jackson

40207

Baptist Health Louisville, Louisville

41003

Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Seville

42701

Baptist Health Woodland, Elizabethtown

44124

A.O.U. Ferrara, Sant'Anna, Cona (Ferrara)

46010

Hospital Clinico Universitario de Valencia, Valencia

46260

Ascension St. Vincent Medical Group, Indianapolis

49100

Rabin MC Beilinson - Heart Failure Unit, Petah Tikva

55905

Mayo Clinic, Rochester

60005

Endeavor Health Clinical Operations-NCH, Arlington Heights

60389

MVZ CCB Frankfurt Und Main-Taunus GbR, Frankfurt

60429

Chicago Medical Research LLC, Hazel Crest

63136

St Louis Heart & Vascular, P.C., St Louis

64111

Saint Luke's Hospital of Kansas City, Kansas City

66606

Cotton-O'Neil Heart Center, Topeka

68124

CHI Health Clinic Cardiology (CUMC - Bergan Mercy), Omaha

68506

Bryan Heart, Lincoln

71105

Grace Research, LLC_Shreveport, Shreveport

71111

Grace Research, LLC, Bossier City

75390

University of Texas Southwestern Medical Center, Dallas

79106

Medical Center - University Of Freiburg, Freiburg im Breisgau

Universitätsklinikum Freiburg - Medical Center, Freiburg im Breisgau

90033

Keck Medical Center of USC - Outpatient Clinic, Los Angeles

91120

Hadassah Ein Karam MC - Cardio Department, Jerusalem

97078

Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz, Würzburg

110002

G B Pant Institute of Postgraduate Medical Education and Research, New Delhi

G B Pant Institute of Postgraduate Medical Education and Res, New Delhi

110017

Max Super Speciality Hospital, Saket, New Delhi

Max Super Speciality Hospital_New Delhi, New Delhi

110029

VMMC & Safdarjung Hospital, New Dehli

110060

Sir Ganga Ram Hospital, New Delhi

226003

Gandhi Memorial Hospital- King George's Medical University, Lucknow

334003

SP Medical College & A.G.Hospital Bikaner, Bikaner

SP Medical College, Bikaner

422005

Vijan Cardiac & Critical Care, Nashik

Vijan Hospital & Research Centre, Nashik

600006

Apollo Hospitals Education & Research Foundation, Chennai

682018

Lisie Hospital, Kochi

5265601

Sheba MC - Cardiology Clinical Research Unit, Tel Litwinsky

6423906

Sourasky MC - Cardio Vascular Research Center, Tel Aviv

23298-5058

Virginia Commonwealth University, Richmond

C1440CFD

CEMEDIC, CABA

CEMEDIC, CABA

C1061AAS.

Centro de Investigación y Prevención Cardiovascular, CABA

C1119ACN

Centro de Investigación y Prevención Cardiovascular, CABA

W3400AMZ

Instituto de Cardiología de Corrientes, Corrientes

B1708IFF

Consultorio Integral de Atención al Diabético, Morón

S2000CVB

Sanatorio Britanico S.A., Rosario, Santa Fe

A 8036

Medizinische Universität Graz, Graz

A 1090

Universitätsklinik für Innere Medizin II, Vienna

T2N 4Z6

University of Calgary_Calgary, Calgary

N1R 6V6

Cambridge Cardiac Care Centre, Cambridge

L3Y 2P6

Partnrs Adv Cardio Eval (PACE), Newmarket

M1B 4Z8

Heart Health Institute Research, Inc., Scarborough Village

J6X 4P7

Ctr de Med Metab de Lanaudiere, Terrebonne

G1V 4G5

Institut universitaire de cardiologie, Québec

550 01

Edumed Broumov, Broumov

120 00

Fakultní poliklinika VFN ambulance Srdecniho selhani, Prague

140 21

IKEM, Prague

170 00

MEDICON a.s., Prague

Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o., Prague

01277

"MVZ Am Felsenkeller (Dresden)", Dresden

04910

Zentrum fuer klinische Studien Suedbrandenburg GmbH, Elsterwerda

04103

Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie, Leipzig

00161

A.O.U. Policlinico Umberto I, Roma

00168

Policlinico A. Gemelli IRCCS, Rome

670-8560

Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology, Himeji-shi, Hyogo

802-8555

Kokura Memorial Hospital_Cardiology, Kitakyushu-shi,Fukuoka

523-0082

Omihachiman Community Medical Center_Omihachiman-shi, Siga, Omihachiman-shi, Siga

534-0021

Osaka City General Hospital_Endocrinology and Diabetes Mellitus, Osaka

062-0003

Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine, Sapporo-shi, Hokkaido

140-8522

Tokyo Shinagawa Hospital_Cardiovascular Medicine, Tokyo

1942 LE

Rode Kruis Ziekenhuis Beverwijk, Beverwijk

9713 GZ

UMC Groningen, Groningen

7772 SE

Saxenburgh Medisch Centrum, Hardenberg

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

4708 AE

Bravis Ziekenhuis, Roosendaal

32-500

Malopolskie Centrum Sercowo-Naczyniowe, Chrzanów

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio, Bialystok

15-540

Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio, Bialystok

81-157

Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman, Gdynia

40-648

Pro Familia Altera Sp. z o.o., Katowice

02-097

I Katedra i Klinika Kardiologii WUM SPCSK, Warsaw

90-549

Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi, Lodz

416 50

Dept of Med Sahlgrenska/Östra, Gothenburg

751 85

Hjärtmottagningen, Uppsala

DD1 9SY

Ninewells Hospital, Dundee

G31 2ER

Glasgow Clinical Research Facility, Glasgow

G51 4TF

Queen Elizabeth University Hospital, Glasgow

HP11 2TT

Wycombe General Hospital, High Wycombe

L9 7AL

University Hospital Aintree, Liverpool

M13 9WL

Manchester Royal Infirmary_Manchester_0, Manchester

SN3 6BB

Great Western Hospital, Swindon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY