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:

Recruiting

Sponsor:

Novo Nordisk A/S

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There are 128 Locations for this study

See Locations Near You

Novo Nordisk Investigational Site
Fairhope Alabama, 36532, United States
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Los Angeles California, 90033, United States
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Brandon Florida, 33511, United States
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Jacksonville Florida, 32258, United States
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Miami Florida, 33173, United States
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Arlington Heights Illinois, 60005, United States
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Evanston Illinois, 60208, United States
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Hazel Crest Illinois, 60429, United States
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Indianapolis Indiana, 46260, United States
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Munster Indiana, 46321, United States
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Topeka Kansas, 66606, United States
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Elizabethtown Kentucky, 42701, United States
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Lexington Kentucky, 40503, United States
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Louisville Kentucky, 40207, United States
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Bossier City Louisiana, 71111, United States
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Shreveport Louisiana, 71105, United States
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Slidell Louisiana, 70458, United States
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Baltimore Maryland, 21239, United States
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Baltimore Maryland, 21287, United States
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Rochester Minnesota, 55902, United States
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Jackson Mississippi, 39216, United States
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Kansas City Missouri, 64111, United States
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Saint Louis Missouri, 63136, United States
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Lincoln Nebraska, 68506, United States
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Omaha Nebraska, 68124, United States
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Morehead City North Carolina, 28557, United States
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Winston-Salem North Carolina, 27157, United States
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Dallas Texas, 75390, United States
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Houston Texas, 77025, United States
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Richmond Virginia, 23298, United States
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Caba , C1119, Argentina
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Caba , C1440, Argentina
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Ciudad Autónoma de Buenos Aire , 1425, Argentina
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Corrientes , W3400, Argentina
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Morón , B1708, Argentina
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Rosario, Santa Fe , S2000, Argentina
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Braunau , A 528, Austria
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Graz , A 803, Austria
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Saint Stefan , 8511, Austria
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Wien , 1100, Austria
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Wien , A 109, Austria
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Wien , A 119, Austria
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Calgary Alberta, T2N 4, Canada
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Cambridge Ontario, N1R 6, Canada
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Newmarket Ontario, L3Y 2, Canada
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Scarborough Ontario, M1B 4, Canada
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Weston Ontario, M9N 1, Canada
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Montreal Quebec, H4A 3, Canada
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Terrebonne Quebec, J6X 4, Canada
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Quebec , G1V 4, Canada
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Broumov , 550 0, Czechia
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Praha 2 , 120 0, Czechia
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Praha 4 , 140 2, Czechia
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Praha 7 , 170 0, Czechia
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Berlin , 13353, Germany
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Dresden , 01277, Germany
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Elsterwerda , 04910, Germany
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Frankfurt , 60389, Germany
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Freiburg , 79106, Germany
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Kassel , 34121, Germany
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Leipzig , 04103, Germany
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Mainz , 55131, Germany
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Würzburg , 97078, Germany
Novo Nordisk Investigational Site
Baja Bács-Kiskun, 6500, Hungary
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Komárom Komárom-Esztergom, 2921, Hungary
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Budapest , 1032, Hungary
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Budapest , 1085, Hungary
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Budapest , 1096, Hungary
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Budapest , 1122, Hungary
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Budapest , 1204, Hungary
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Debrecen , 4032, Hungary
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Miskolc , 3526, Hungary
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Zalaegerszeg , 8900, Hungary
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Kochi Kerala, 68201, India
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Nashik Maharashtra, 42200, India
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New Dehli New Delhi, 11002, India
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Bikaner Rajasthan, 33400, India
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Chennai Tamil Nadu, 60000, India
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Lucknow Uttar Pradesh, 22600, India
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New Delhi , 11000, India
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New Delhi , 11001, India
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New Delhi , 11006, India
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Jerusalem , 91120, Israel
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Nahariya , 22100, Israel
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Petah-Tikva , 49100, Israel
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Tel Aviv , 64239, Israel
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Tel Hashomer , 52656, Israel
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Bergamo Bg, 24127, Italy
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Brescia Bs, 25123, Italy
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Cona (Ferrara) Fe, 44124, Italy
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Milano , 20138, Italy
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Padova , 35128, Italy
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Roma , 00161, Italy
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Rome , 00168, Italy
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Himeji-shi, Hyogo , 670-8, Japan
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Kitakyushu-shi,Fukuoka , 802-8, Japan
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Okayama-shi, Okayama , 700-8, Japan
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Omihachiman-shi, Siga , 523-0, Japan
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Osaka-shi, Osaka , 530-8, Japan
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Osaka , 534-0, Japan
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Sapporo-shi, Hokkaido , 062-0, Japan
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Tokyo , 140-8, Japan
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Apeldoorn , 7334 , Netherlands
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Arnhem , 6815 , Netherlands
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Beverwijk , 1942 , Netherlands
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Groningen , 9713 , Netherlands
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Hardenberg , 7772 , Netherlands
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Leeuwarden , 8934 , Netherlands
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Roosendaal , 4708 , Netherlands
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Lodz Lodzkie, 90-54, Poland
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Bialystok Podlaskie, 15-27, Poland
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Chrzanow , 32-50, Poland
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Gdynia , 81-15, Poland
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Warsaw , 02-09, Poland
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Katowice Śląskie, 40-64, Poland
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Santiago de Compostela , 15706, Spain
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Sevilla , 41003, Spain
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Valencia , 46010, Spain
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Göteborg , 416 5, Sweden
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Jönköping , 551 8, Sweden
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Uppsala , 751 8, Sweden
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Dundee , DD1 9, United Kingdom
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Glasgow , G31 2, United Kingdom
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Glasgow , G51 4, United Kingdom
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High Wycombe , HP11 , United Kingdom
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Liverpool , L9 7A, United Kingdom
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Manchester , M13 9, United Kingdom
Novo Nordisk Investigational Site
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:

Recruiting

Sponsor:


Novo Nordisk A/S

How clear is this clinincal trial information?

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