Heart Failure Clinical Trial

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

Summary

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.

This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.

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 and physical activity.

The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor.

At 6 of the visits participants will have blood samples taken.
At 5 of the visits participants will be asked to fill in a questionnaire
At 4 of the visits participants will have to do a 6-minute walking test
At 3 of the visits participants will have a test to check the heart.
participants will have their eyes checked before or at the start of the study and at the end of the study

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female, age above or equal to 18 years at the time of signing informed consent.
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% at screening
Diagnosed with T2D greater than or equal to 90 days prior to the day of screening
HbA1c of below or equal to 10.0% as measured at the screening visit

Exclusion Criteria:

A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

610

Study ID:

NCT04916470

Recruitment Status:

Completed

Sponsor:

Novo Nordisk A/S

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There are 110 Locations for this study

See Locations Near You

Eastern Shore Rsrch Inst, LLC
Fairhope Alabama, 36532, United States
Keck Medical Center of USC - Outpatient Clinic
Los Angeles California, 90033, United States
Baptist Heart Specialists_Jacksonville
Jacksonville Florida, 32258, United States
Northwest Heart Clinical Research, LLC
Arlington Heights Illinois, 60005, United States
Chicago Medical Research LLC
Hazel Crest Illinois, 60429, United States
Ascension St. Vincent Medical Group
Indianapolis Indiana, 46260, United States
Cotton-O'Neil Heart Center
Topeka Kansas, 66606, United States
Baptist Health Woodland
Elizabethtown Kentucky, 42701, United States
Baptist Health Louisville
Louisville Kentucky, 40207, United States
Grace Research, LLC
Bossier City Louisiana, 71111, United States
Grace Research, LLC_Shreveport
Shreveport Louisiana, 71105, United States
John Hopkins Hospital
Baltimore Maryland, 21287, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Univ of Mississippi Med Ctr
Jackson Mississippi, 39216, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
St Louis Heart & Vascular, P.C.
Saint Louis Missouri, 63136, United States
Bryan Heart
Lincoln Nebraska, 68506, United States
CHI Health Clinic Cardiology (CUMC - Bergan Mercy)
Omaha Nebraska, 68124, United States
Carteret Medical Group
Morehead City North Carolina, 28557, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Centro de Investigación y Prevención Cardiovascular
Caba , C1061, Argentina
Centro de Investigación y Prevención Cardiovascular
Caba , C1119, Argentina
CEMEDIC
Caba , C1440, Argentina
Cardiología Palermo
Ciudad Autónoma de Buenos Aire , 1425, Argentina
Instituto de Cardiología de Corrientes
Corrientes , W3400, Argentina
Consultorio Integral de Atención al Diabético
Morón , B1708, Argentina
Sanatorio Britanico S.A.
Rosario, Santa Fe , S2000, Argentina
Krankenhaus St. Josef Braunau
Braunau , A 528, Austria
Medizinische Universität Graz
Graz , A 803, Austria
Fließer-Görzer [Ordination]
Saint Stefan , 8511, Austria
Universitätsklinik für Innere Medizin II
Wien , A 109, Austria
Imed 19- privat
Wien , A 119, Austria
University of Calgary_Calgary
Calgary Alberta, T2N 4, Canada
Cambridge Cardiac Care Centre
Cambridge Ontario, N1R 6, Canada
Partnrs Adv Cardio Eval (PACE)
Newmarket Ontario, L3Y 2, Canada
Heart Health Institute Research, Inc.
Scarborough Ontario, M1B 4, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne Quebec, J6X 4, Canada
Institut universitaire de cardiologie
Quebec , G1V 4, Canada
Edumed Broumov
Broumov , 550 0, Czechia
Fakultní poliklinika VFN ambulance Srdecniho selhani
Praha 2 , 120 0, Czechia
IKEM
Praha 4 , 140 2, Czechia
Poliklinika Holešovice VISIONARY - MEDICON a.s.
Praha 7 , 170 0, Czechia
Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.
Praha 7 , 170 0, Czechia
Charite Universitatsmedizin Berlin KöR
Berlin , 13353, Germany
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
Dresden , 01277, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda , 04910, Germany
MVZ CCB Frankfurt Und Main-Taunus GbR
Frankfurt , 60389, Germany
Medical Center - University Of Freiburg
Freiburg , 79106, Germany
University of Leipzig
Leipzig , 04103, Germany
Universitatsklinikum Wurzburg AöR
Würzburg , 97078, Germany
Lausmed Kft.
Baja Bács-Kiskun Vármegye, 6500, Hungary
Selye János Kórház
Komárom Komárom-Esztergom, 2921, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest , 1032, Hungary
Semmelweis Egyetem Szent Rókus Klinikai Tömb
Budapest , 1085, Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest , 1096, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
Budapest , 1122, Hungary
Jahn Ferenc Dél-pesti Kórház és Rendelőintézet
Budapest , 1204, Hungary
DE KK Kardiológiai és Szívsebészeti klinika
Debrecen , 4032, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház
Miskolc , 3526, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg , 8900, Hungary
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi Delhi, 11000, India
Max Super Speciality Hospital, Saket
New Delhi Delhi, 11001, India
Lisie Hospital
Kochi Kerala, 68201, India
Vijan Cardiac & Critical Care
Nashik Maharashtra, 42200, India
Vijan Hospital & Research Centre
Nashik Maharashtra, 42200, India
VMMC & Safdarjung Hospital
New Dehli New Delhi, 11002, India
SP Medical College & A.G.Hospital Bikaner
Bikaner Rajasthan, 33400, India
SP Medical College
Bikaner Rajasthan, 33400, India
Apollo Hospitals Education & Research Foundation
Chennai Tamil Nadu, 60000, India
Gandhi Memorial Hospital- King George's Medical University
Lucknow Uttar Pradesh, 22600, India
G B Pant Institute of Postgraduate Medical Education and Res
New Delhi , 11000, India
Max Super Speciality Hospital_New Delhi
New Delhi , 11001, India
Sir Ganga Ram Hospital
New Delhi , 11006, India
Hadassah Ein Kerem MC - Cardio
Jerusalem , 91120, Israel
Cardiology department, Western Galilee Medical Center
Nahariya , 22100, Israel
Heart Failure Unit, Rabin Medical Center - Beilinson Campus
Petah-Tikva , 49100, Israel
Cardio Vascular Research Center Sourasky MC
Tel Aviv , 64239, Israel
Sheba Medica Center - Clinical Research Unit
Tel Hashomer , 52656, Israel
ASST Papa Giovanni XXIII
Bergamo Bg, 24127, Italy
Spedali Civili Brescia
Brescia Bs, 25123, Italy
A.O.U. Ferrara, Sant'Anna
Cona (Ferrara) Fe, 44124, Italy
Centro Cardiologico Monzino. Istituto di Ricovero e Cura
Milano , 20138, Italy
A.O.U. Policlinico Umberto I
Roma , 00161, Italy
Policlinico A. Gemelli IRCCS
Rome , 00168, Italy
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
Himeji-shi, Hyogo , 670-8, Japan
Kokura Memorial Hospital, Cardiology
Kitakyushu-shi,Fukuoka , 802-8, Japan
Omihachiman Community Medical Center_Omihachiman-shi, Siga
Omihachiman-shi, Siga , 523-0, Japan
Osaka City General Hospital
Osaka , 534-0, Japan
Hanaoka Seishu Memorial Hospital
Sapporo-shi, Hokkaido , 062-0, Japan
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
Tokyo , 140-8, Japan
Rode Kruis Ziekenhuis Beverwijk
Beverwijk , 1942 , Netherlands
UMC Groningen
Groningen , 9713 , Netherlands
Saxenburgh Medisch Centrum
Hardenberg , 7772 , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden , 8934 , Netherlands
Bravis Ziekenhuis
Roosendaal , 4708 , Netherlands
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Lodz Lodzkie, 90-54, Poland
Malopolskie Centrum Sercowo-Naczyniowe
Chrzanow Malopolskie, 32-50, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
Bialystok Podlaskie, 15-27, Poland
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
Gdynia , 81-15, Poland
I Katedra i Klinika Kardiologii WUM SPCSK
Warsaw , 02-09, Poland
Pro Familia Altera Sp. z o.o.
Katowice Śląskie, 40-64, Poland
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela , 15706, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Sevilla , 41003, Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain
Dept of Med Sahlgrenska/Östra
Göteborg , 416 5, Sweden
Hjärtmottagningen
Uppsala , 751 8, Sweden
Ninewells Hospital
Dundee , DD1 9, United Kingdom
Glasgow Clinical Research Facility
Glasgow , G31 2, United Kingdom
Queen Elizabeth University Hospital
Glasgow , G51 4, United Kingdom
Wycombe General Hospital
High Wycombe , HP11 , United Kingdom
University Hospital Aintree
Liverpool , L9 7A, United Kingdom
Manchester Royal Infirmary_Manchester_0
Manchester , M13 9, United Kingdom
Great Western Hospital
Swindon , SN3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

610

Study ID:

NCT04916470

Recruitment Status:

Completed

Sponsor:


Novo Nordisk A/S

How clear is this clinincal trial information?

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