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.
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.
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There are 128 Locations for this study
Fairhope Alabama, 36532, United States
Los Angeles California, 90033, United States
Brandon Florida, 33511, United States
Jacksonville Florida, 32258, United States
Miami Florida, 33173, United States
Arlington Heights Illinois, 60005, United States
Evanston Illinois, 60208, United States
Hazel Crest Illinois, 60429, United States
Indianapolis Indiana, 46260, United States
Munster Indiana, 46321, United States
Topeka Kansas, 66606, United States
Elizabethtown Kentucky, 42701, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40207, United States
Bossier City Louisiana, 71111, United States
Shreveport Louisiana, 71105, United States
Slidell Louisiana, 70458, United States
Baltimore Maryland, 21239, United States
Baltimore Maryland, 21287, United States
Rochester Minnesota, 55902, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63136, United States
Lincoln Nebraska, 68506, United States
Omaha Nebraska, 68124, United States
Morehead City North Carolina, 28557, United States
Winston-Salem North Carolina, 27157, United States
Dallas Texas, 75390, United States
Houston Texas, 77025, United States
Richmond Virginia, 23298, 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
Braunau , A 528, Austria
Graz , A 803, Austria
Saint Stefan , 8511, Austria
Wien , 1100, Austria
Wien , A 109, Austria
Wien , A 119, Austria
Calgary Alberta, T2N 4, Canada
Cambridge Ontario, N1R 6, Canada
Newmarket Ontario, L3Y 2, Canada
Scarborough Ontario, M1B 4, Canada
Weston Ontario, M9N 1, Canada
Montreal Quebec, H4A 3, Canada
Terrebonne Quebec, J6X 4, Canada
Quebec , G1V 4, Canada
Broumov , 550 0, Czechia
Praha 2 , 120 0, Czechia
Praha 4 , 140 2, Czechia
Praha 7 , 170 0, Czechia
Berlin , 13353, Germany
Dresden , 01277, Germany
Elsterwerda , 04910, Germany
Frankfurt , 60389, Germany
Freiburg , 79106, Germany
Kassel , 34121, Germany
Leipzig , 04103, Germany
Mainz , 55131, 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
Debrecen , 4032, Hungary
Miskolc , 3526, Hungary
Zalaegerszeg , 8900, Hungary
Kochi Kerala, 68201, India
Nashik Maharashtra, 42200, India
New Dehli New Delhi, 11002, India
Bikaner Rajasthan, 33400, India
Chennai Tamil Nadu, 60000, India
Lucknow Uttar Pradesh, 22600, India
New Delhi , 11000, India
New Delhi , 11001, India
New Delhi , 11006, India
Jerusalem , 91120, Israel
Nahariya , 22100, Israel
Petah-Tikva , 49100, Israel
Tel Aviv , 64239, Israel
Tel Hashomer , 52656, Israel
Bergamo Bg, 24127, Italy
Brescia Bs, 25123, Italy
Cona (Ferrara) Fe, 44124, Italy
Milano , 20138, Italy
Padova , 35128, Italy
Roma , 00161, Italy
Rome , 00168, Italy
Himeji-shi, Hyogo , 670-8, Japan
Kitakyushu-shi,Fukuoka , 802-8, Japan
Okayama-shi, Okayama , 700-8, Japan
Omihachiman-shi, Siga , 523-0, Japan
Osaka-shi, Osaka , 530-8, Japan
Osaka , 534-0, Japan
Sapporo-shi, Hokkaido , 062-0, Japan
Tokyo , 140-8, Japan
Apeldoorn , 7334 , Netherlands
Arnhem , 6815 , 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 Śląskie, 40-64, Poland
Santiago de Compostela , 15706, Spain
Sevilla , 41003, Spain
Valencia , 46010, Spain
Göteborg , 416 5, Sweden
Jönköping , 551 8, Sweden
Uppsala , 751 8, Sweden
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
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