Heart Failure Clinical Trial
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
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 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 percentage at screening
Exclusion Criteria:
A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
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There are 88 Locations for this study
Fairhope Alabama, 36532, United States
Arlington Heights Illinois, 60005, United States
Evanston Illinois, 60208, United States
Hazel Crest Illinois, 60429, United States
Kansas City Kansas, 66160, United States
Topeka Kansas, 66606, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40207, United States
Hammond Louisiana, 70403, United States
Baltimore Maryland, 21287, United States
Rochester Minnesota, 55902, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63136, United States
Greenvale New York, 11548, United States
New York New York, 10065, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45219, United States
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75390, United States
Caba , C1119, Argentina
Caba , C1440, Argentina
Ciudad Autónoma de Buenos Aire , 1425, Argentina
Corrientes , W3400, Argentina
Morón , B1708, Argentina
Rosario, Santa Fe , S2000, Argentina
Garran Australian Capital Territory, 2605, Australia
Concord New South Wales, 2139, Australia
Liverpool New South Wales, 2170, Australia
Bedford Park South Australia, 5042, Australia
Geelong Victoria, 3220, Australia
Cambridge Ontario, N1R 6, Canada
Newmarket Ontario, L3Y 2, Canada
Scarborough Ontario, M1B 4, Canada
Quebec , G1V 4, Canada
Jihlava , 586 3, Czechia
Praha 2 , 128 0, Czechia
Praha 4 , 140 2, Czechia
Praha 7 , 170 0, Czechia
Slany , 274 0, Czechia
Tábor , 390 0, Czechia
Hellerup Region Hovedstaden, 2900, Denmark
Aarhus N , 8200, Denmark
Svendborg , 5700, Denmark
Berlin , 13353, Germany
Dresden , 01277, Germany
Elsterwerda , 04910, Germany
Frankfurt , 60389, Germany
Freiburg , 79106, Germany
Kassel , 34121, Germany
Würzburg , 97078, Germany
Baja Bács-Kiskun, 6500, Hungary
Komárom Komárom-Esztergom, 2921, Hungary
Budapest , 1032, Hungary
Budapest , 1085, Hungary
Budapest , 1096, Hungary
Budapest , 1122, Hungary
Budapest , 1204, Hungary
Miskolc , 3526, Hungary
Zalaegerszeg , 8900, Hungary
Jerusalem , 91120, Israel
Nahariya , 22100, Israel
Petah-Tikva , 49100, Israel
Tel Aviv , 64239, Israel
Tel Hashomer , 52656, Israel
Apeldoorn , 7334 , Netherlands
Beverwijk , 1942 , Netherlands
Groningen , 9713 , Netherlands
Hardenberg , 7772 , Netherlands
Leeuwarden , 8934 , Netherlands
Roosendaal , 4708 , Netherlands
Lodz Lodzkie, 90-54, Poland
Bialystok Podlaskie, 15-27, Poland
Chrzanow , 32-50, Poland
Gdynia , 81-15, Poland
Warsaw , 02-09, Poland
Katowice ÅšlÄ…skie, 40-64, Poland
Madrid , 28023, Spain
Santiago de Compostela , 15706, Spain
Valencia , 46010, Spain
Bristol , BS10 , United Kingdom
Dundee , DD1 9, United Kingdom
Glasgow , G31 2, United Kingdom
Glasgow , G51 4, United Kingdom
High Wycombe , HP11 , United Kingdom
Liverpool , L9 7A, United Kingdom
Manchester , M13 9, United Kingdom
Swindon , SN3 6, United Kingdom
West Sussex , PO19 , United Kingdom
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