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.

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 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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

529

Study ID:

NCT04788511

Recruitment Status:

Completed

Sponsor:

Novo Nordisk A/S

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There are 88 Locations for this study

See Locations Near You

Novo Nordisk Investigational Site
Fairhope Alabama, 36532, United States
Novo Nordisk Investigational Site
Arlington Heights Illinois, 60005, United States
Novo Nordisk Investigational Site
Evanston Illinois, 60208, United States
Novo Nordisk Investigational Site
Hazel Crest Illinois, 60429, United States
Novo Nordisk Investigational Site
Kansas City Kansas, 66160, United States
Novo Nordisk Investigational Site
Topeka Kansas, 66606, United States
Novo Nordisk Investigational Site
Lexington Kentucky, 40503, United States
Novo Nordisk Investigational Site
Louisville Kentucky, 40207, United States
Novo Nordisk Investigational Site
Hammond Louisiana, 70403, United States
Novo Nordisk Investigational Site
Baltimore Maryland, 21287, United States
Novo Nordisk Investigational Site
Rochester Minnesota, 55902, United States
Novo Nordisk Investigational Site
Kansas City Missouri, 64111, United States
Novo Nordisk Investigational Site
Saint Louis Missouri, 63136, United States
Novo Nordisk Investigational Site
Greenvale New York, 11548, United States
Novo Nordisk Investigational Site
New York New York, 10065, United States
Novo Nordisk Investigational Site
Winston-Salem North Carolina, 27157, United States
Novo Nordisk Investigational Site
Cincinnati Ohio, 45219, United States
Novo Nordisk Investigational Site
Philadelphia Pennsylvania, 19104, United States
Novo Nordisk Investigational Site
Dallas Texas, 75390, United States
Novo Nordisk Investigational Site
Caba , C1119, Argentina
Novo Nordisk Investigational Site
Caba , C1440, Argentina
Novo Nordisk Investigational Site
Ciudad Autónoma de Buenos Aire , 1425, Argentina
Novo Nordisk Investigational Site
Corrientes , W3400, Argentina
Novo Nordisk Investigational Site
Morón , B1708, Argentina
Novo Nordisk Investigational Site
Rosario, Santa Fe , S2000, Argentina
Novo Nordisk Investigational Site
Garran Australian Capital Territory, 2605, Australia
Novo Nordisk Investigational Site
Concord New South Wales, 2139, Australia
Novo Nordisk Investigational Site
Liverpool New South Wales, 2170, Australia
Novo Nordisk Investigational Site
Bedford Park South Australia, 5042, Australia
Novo Nordisk Investigational Site
Geelong Victoria, 3220, Australia
Novo Nordisk Investigational Site
Cambridge Ontario, N1R 6, Canada
Novo Nordisk Investigational Site
Newmarket Ontario, L3Y 2, Canada
Novo Nordisk Investigational Site
Scarborough Ontario, M1B 4, Canada
Novo Nordisk Investigational Site
Quebec , G1V 4, Canada
Novo Nordisk Investigational Site
Jihlava , 586 3, Czechia
Novo Nordisk Investigational Site
Praha 2 , 128 0, Czechia
Novo Nordisk Investigational Site
Praha 4 , 140 2, Czechia
Novo Nordisk Investigational Site
Praha 7 , 170 0, Czechia
Novo Nordisk Investigational Site
Slany , 274 0, Czechia
Novo Nordisk Investigational Site
Tábor , 390 0, Czechia
Novo Nordisk Investigational Site
Hellerup Region Hovedstaden, 2900, Denmark
Novo Nordisk Investigational Site
Aarhus N , 8200, Denmark
Novo Nordisk Investigational Site
Svendborg , 5700, Denmark
Novo Nordisk Investigational Site
Berlin , 13353, Germany
Novo Nordisk Investigational Site
Dresden , 01277, Germany
Novo Nordisk Investigational Site
Elsterwerda , 04910, Germany
Novo Nordisk Investigational Site
Frankfurt , 60389, Germany
Novo Nordisk Investigational Site
Freiburg , 79106, Germany
Novo Nordisk Investigational Site
Kassel , 34121, Germany
Novo Nordisk Investigational Site
Würzburg , 97078, Germany
Novo Nordisk Investigational Site
Baja Bács-Kiskun, 6500, Hungary
Novo Nordisk Investigational Site
Komárom Komárom-Esztergom, 2921, Hungary
Novo Nordisk Investigational Site
Budapest , 1032, Hungary
Novo Nordisk Investigational Site
Budapest , 1085, Hungary
Novo Nordisk Investigational Site
Budapest , 1096, Hungary
Novo Nordisk Investigational Site
Budapest , 1122, Hungary
Novo Nordisk Investigational Site
Budapest , 1204, Hungary
Novo Nordisk Investigational Site
Miskolc , 3526, Hungary
Novo Nordisk Investigational Site
Zalaegerszeg , 8900, Hungary
Novo Nordisk Investigational Site
Jerusalem , 91120, Israel
Novo Nordisk Investigational Site
Nahariya , 22100, Israel
Novo Nordisk Investigational Site
Petah-Tikva , 49100, Israel
Novo Nordisk Investigational Site
Tel Aviv , 64239, Israel
Novo Nordisk Investigational Site
Tel Hashomer , 52656, Israel
Novo Nordisk Investigational Site
Apeldoorn , 7334 , Netherlands
Novo Nordisk Investigational Site
Beverwijk , 1942 , Netherlands
Novo Nordisk Investigational Site
Groningen , 9713 , Netherlands
Novo Nordisk Investigational Site
Hardenberg , 7772 , Netherlands
Novo Nordisk Investigational Site
Leeuwarden , 8934 , Netherlands
Novo Nordisk Investigational Site
Roosendaal , 4708 , Netherlands
Novo Nordisk Investigational Site
Lodz Lodzkie, 90-54, Poland
Novo Nordisk Investigational Site
Bialystok Podlaskie, 15-27, Poland
Novo Nordisk Investigational Site
Chrzanow , 32-50, Poland
Novo Nordisk Investigational Site
Gdynia , 81-15, Poland
Novo Nordisk Investigational Site
Warsaw , 02-09, Poland
Novo Nordisk Investigational Site
Katowice ÅšlÄ…skie, 40-64, Poland
Novo Nordisk Investigational Site
Madrid , 28023, Spain
Novo Nordisk Investigational Site
Santiago de Compostela , 15706, Spain
Novo Nordisk Investigational Site
Valencia , 46010, Spain
Novo Nordisk Investigational Site
Bristol , BS10 , United Kingdom
Novo Nordisk Investigational Site
Dundee , DD1 9, United Kingdom
Novo Nordisk Investigational Site
Glasgow , G31 2, United Kingdom
Novo Nordisk Investigational Site
Glasgow , G51 4, United Kingdom
Novo Nordisk Investigational Site
High Wycombe , HP11 , United Kingdom
Novo Nordisk Investigational Site
Liverpool , L9 7A, United Kingdom
Novo Nordisk Investigational Site
Manchester , M13 9, United Kingdom
Novo Nordisk Investigational Site
Swindon , SN3 6, United Kingdom
Novo Nordisk Investigational Site
West Sussex , PO19 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

529

Study ID:

NCT04788511

Recruitment Status:

Completed

Sponsor:


Novo Nordisk A/S

How clear is this clinincal trial information?

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