Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

Last updated: February 6, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Chest Pain

Diabetes Prevention

Treatment

Semaglutide

Placebo (semaglutide)

Clinical Study ID

NCT04788511
EX9536-4665
2019-004452-11
U1111-1243-4358
  • Ages > 18
  • All Genders

Study Summary

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.

During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity.

The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informedconsent.

  • Body mass index (BMI) greater than or equal to 30.0 kg/m^2

  • New York Heart Association (NYHA) Class II-IV

  • Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage atscreening

Exclusion

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysbefore screening irrespective of medical records

  • Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) basedon latest available value from medical records, no older than 3 months or ifunavailable a local measurement at screening

Study Design

Total Participants: 529
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
March 16, 2021
Estimated Completion Date:
April 18, 2023

Connect with a study center

  • CEMEDIC

    Caba, Buenos Aires C1440CFD
    Argentina

    Site Not Available

  • Instituto de Cardiología de Corrientes

    Corrientes, Buenos Aires W3400AMZ
    Argentina

    Site Not Available

  • Centro de Investigación y Prevención Cardiovascular

    Caba, C1061AAS.
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Caba, C1440CFD
    Argentina

    Site Not Available

  • Cardiología Palermo

    Ciudad Autónoma de Buenos Aire, 1425
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Ciudad Autónoma de Buenos Aire, 1425
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Consultorio Integral de Atención al Diabético

    Morón, B1708IFF
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Morón, B1708IFF
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Rosario, Santa Fe, S2000CVB
    Argentina

    Site Not Available

  • Sanatorio Britanico S.A.

    Rosario, Santa Fe, S2000CVB
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • The Canberra Hospital_Garran

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Concord Repatriation General Hospital - Cardiology

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Geelong Cardiology Research Unit

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario N1R 6V6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Cambridge, Ontario N1R 6V6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Newmarket, Ontario L3Y 2P6
    Canada

    Site Not Available

  • Partnrs Adv Cardio Eval (PACE)

    Newmarket, Ontario L3Y 2P6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Oakville, Ontario L6K 3W7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Oshawa, Ontario L1J 2K1
    Canada

    Site Not Available

  • Heart Health Institute Research, Inc.

    Scarborough, Ontario M1B 4Z8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Scarborough, Ontario M1B 4Z8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M9N 1W4
    Canada

    Site Not Available

  • Institut Universitaire de Cardiologie et de Pneumologie. de Quebec - Universite Laval

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Nemocnice Jihlava Kardiologie

    Jihlava, 586 33
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Jihlava, 586 33
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 2, 128 00
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice a 1 LF UK v Praze

    Praha 2, 128 00
    Czechia

    Site Not Available

  • IKEM

    Praha 4, 140 21
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4, 140 21
    Czechia

    Site Not Available

  • MEDICON a.s.

    Praha 7, 170 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 7, 170 00
    Czechia

    Site Not Available

  • Poliklinika Holešovice VISIONARY - MEDICON a.s.

    Praha 7, 170 00
    Czechia

    Site Not Available

  • Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.

    Praha 7, 170 00
    Czechia

    Site Not Available

  • Nemocnice Slany Kardiologie

    Slany, 274 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Slany, 274 01
    Czechia

    Site Not Available

  • Nemocnice Tábor a.s.

    Tábor, 390 03
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Tábor, 390 03
    Czechia

    Site Not Available

  • Herlev og Gentofte Hospital

    Hellerup, Region Hovedstaden 2900
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hellerup, Region Hovedstaden 2900
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Hjertesygdomme

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Skejby Hjertesygdomme

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Kardiologisk Odense & Svendborg

    Svendborg, 5700
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Svendborg, 5700
    Denmark

    Site Not Available

  • Charite Universitatsmedizin Berlin KöR

    Berlin, 13353
    Germany

    Site Not Available

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

    Berlin, 13353
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 13353
    Germany

    Site Not Available

  • Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH

    Dresden, 01277
    Germany

    Site Not Available

  • MVZ "Am Felsenkeller" (Dresden)

    Dresden, 01277
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Dresden, 01277
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910
    Germany

    Site Not Available

  • Zentrum fuer klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910
    Germany

    Site Not Available

  • MVZ CCB Frankfurt Und Main-Taunus GbR

    Frankfurt, 60389
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Frankfurt, 60389
    Germany

    Site Not Available

  • Medical Center - University Of Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Appel

    Kassel, 34121
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Kassel, 34121
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Würzburg, 97078
    Germany

    Site Not Available

  • Universitatsklinikum Wurzburg AöR

    Würzburg, 97078
    Germany

    Site Not Available

  • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

    Würzburg, 97078
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Baja, Bács-Kiskun 6500
    Hungary

    Site Not Available

  • Lausmed Kft.

    Baja, Bács-Kiskun Vármegye 6500
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Komárom, Komárom-Esztergom 2921
    Hungary

    Site Not Available

  • Selye János Kórház

    Komárom, Komárom-Esztergom 2921
    Hungary

    Site Not Available

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096
    Hungary

    Site Not Available

  • Jahn Ferenc Dél-pesti Kórház és Rendelőintézet

    Budapest, 1204
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, 1096
    Hungary

    Site Not Available

  • Semmelweis Egyetem Szent Rókus Klinikai Tömb

    Budapest, 1085
    Hungary

    Site Not Available

  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászat

    Budapest, 1122
    Hungary

    Site Not Available

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032
    Hungary

    Site Not Available

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház

    Miskolc, 3526
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Miskolc, 3526
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Hadassah Ein Kerem MC - Cardio

    Jerusalem, 91120
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • Cardiology department, Western Galilee Medical Center

    Nahariya, 22100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Nahariya, 22100
    Israel

    Site Not Available

  • Heart Failure Unit, Rabin Medical Center - Beilinson Campus

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Cardio Vascular Research Center Sourasky MC

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Hashomer, 5265601
    Israel

    Site Not Available

  • Sheba Medica Center - Clinical Research Unit

    Tel Hashomer, 5265601
    Israel

    Site Not Available

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Apeldoorn, 7334 DZ
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Beverwijk, 1942 LE
    Netherlands

    Site Not Available

  • Rode Kruis Ziekenhuis Beverwijk

    Beverwijk, 1942 LE
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • UMC Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Hardenberg, 7772 SE
    Netherlands

    Site Not Available

  • Saxenburgh Medisch Centrum

    Hardenberg, 7772 SE
    Netherlands

    Site Not Available

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Bravis Ziekenhuis

    Roosendaal, 4708 AE
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Roosendaal, 4708 AE
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodz, Lodzkie 90-549
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow

    Lodz, Lodzkie 90-549
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi

    Lodz, Lodzkie 90-549
    Poland

    Site Not Available

  • Malopolskie Centrum Sercowo-Naczyniowe

    Chrzanow, Malopolskie 32-500
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bialystok, Podlaskie 15-276
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio

    Bialystok, Podlaskie 15-540
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Katowice, Śląskie 40-648
    Poland

    Site Not Available

  • Pro Familia Altera Sp. z o.o.

    Katowice, Śląskie 40-648
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Chrzanow, 32-500
    Poland

    Site Not Available

  • Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman

    Gdynia, 81-157
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdynia, 81-157
    Poland

    Site Not Available

  • I Katedra i Klinika Kardiologii WUM SPCSK

    Warsaw, 02-097
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warsaw, 02-097
    Poland

    Site Not Available

  • Hospital Universitario La Zarzuela

    Madrid, 28023
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28023
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Valencia, 46010
    Spain

    Site Not Available

  • St. Richards Hospital

    Chichester, West Sussex PO19 6SE
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Ninewells Hospital

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Glasgow Clinical Research Facility

    Glasgow, G31 2ER
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    High Wycombe, HP11 2TT
    United Kingdom

    Site Not Available

  • Wycombe General Hospital

    High Wycombe, HP11 2TT
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • University Hospital Aintree

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary_Manchester_0

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Great Western Hospital

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    West Sussex, PO19 6SE
    United Kingdom

    Site Not Available

  • St. Richards Hospital

    West Sussex, PO19 6SE
    United Kingdom

    Site Not Available

  • Eastern Shore Rsrch Inst, LLC

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32258
    United States

    Site Not Available

  • Northwest Heart Clin. Res.

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Northwest Heart Clinical Research, LLC

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University_Chicago_0

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Chicago Medical Research LLC

    Hazel Crest, Illinois 60429
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hazel Crest, Illinois 60429
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46260-1992
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Cotton-O'Neil Heart Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • The Research Group of Lexington LLC

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Baptist Health Louisville

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bossier City, Louisiana 71111
    United States

    Site Not Available

  • Heart Clinic of Hammond

    Hammond, Louisiana 70403
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hammond, Louisiana 70403
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • John Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • St Louis Heart & Vascular, P.C.

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenvale, New York 11548
    United States

    Site Not Available

  • St Francis Hospital Lindner Research Center

    Greenvale, New York 11548
    United States

    Site Not Available

  • NY Presbyt Hosp-W Cornell Med

    New York, New York 10021
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10065
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roslyn, New York 11576
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Lindner Center,Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Hospital of University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Falls Church, Virginia 22042
    United States

    Site Not Available

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