Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo (Semaglutide)
- Registration Number
- NCT04916470
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 617
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide placebo OW Placebo (Semaglutide) Participants will receive semaglutide placebo injections for 52 weeks. Semaglutide 2.4 mg once weekly (OW) Semaglutide Participants will receive semaglutide injections for 52 weeks.
- Primary Outcome Measures
Name Time Method Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score From baseline (week 0) to end of treatment (week 52) Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
Change in body weight From baseline (week 0) to end of treatment (week 52) Percentage (%)
- Secondary Outcome Measures
Name Time Method Participant achieving threshold for clinically meaningful within-subject change in 6MWD From baseline (week 0) to end of treatment (week 52) Count of participants
Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio) From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group.
Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group.
Participant achieving 15% weight loss or more (Yes/No) From baseline (week 0) to end of treatment (week 52) Count of participants
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group
Participant improving 5 points or more in KCCQ clinical summary score From baseline (week 0) to end of treatment (week 52) Count of participants
Change in systolic blood pressure From baseline (week -2) to end of treatment (week 52) Measured in millimetre of mercury (mmHg)
Number of treatment emergent severe or clinically significant hypoglycaemia episodes From baseline (week 0) to end of trial (week 57) Count of events
Participant achieving 20% weight loss or more (Yes/No) From baseline (week 0) to end of treatment (week 52) Count of participants
Change in 6-minute walking distance From baseline (week 0) to end of treatment (week 52) Measured in metres
Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group.
Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS From baseline (week 0) to end of treatment (week 52) Count of participants
Change in waist circumference From baseline (week 0) to end of treatment (visit 52) Measured in centimetre (cm)
Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 52) Measured in percentage (%)-point
Hierarchical composite of time to all-cause death From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group.
Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group.
Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks From baseline (week 0) to end of study (week 57) Measured as total wins for each treatment group.
Change in C-Reactive Protein From baseline (week -2) to end of treatment (week 52) Presented as ratio to baseline
Participant achieving 10% weight loss or more (Yes/No) From baseline (week 0) to end of treatment (week 52) Count of participants
Participant improving 10 points or more in KCCQ clinical summary score (Yes/No) From baseline (week 0) to end of treatment (week 52) Count of participants
Change in KCCQ overall summary score From baseline (week 0) to end of treatment (week 52) Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
Trial Locations
- Locations (114)
Gandhi Memorial Hospital- King George's Medical University
🇮🇳Lucknow, Uttar Pradesh, India
G B Pant Institute of Postgraduate Medical Education and Res
🇮🇳New Delhi, India
Max Super Speciality Hospital_New Delhi
🇮🇳New Delhi, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, India
Hadassah Ein Kerem MC - Cardio
🇮🇱Jerusalem, Israel
Cardiology department, Western Galilee Medical Center
🇮🇱Nahariya, Israel
Heart Failure Unit, Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Cardio Vascular Research Center Sourasky MC
🇮🇱Tel Aviv, Israel
Sheba Medica Center - Clinical Research Unit
🇮🇱Tel Hashomer, Israel
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Bg, Italy
Spedali Civili Brescia
🇮🇹Brescia, Bs, Italy
A.O.U. Ferrara, Sant'Anna
🇮🇹Cona (Ferrara), Fe, Italy
Centro Cardiologico Monzino. Istituto di Ricovero e Cura
🇮🇹Milano, Italy
A.O.U. Policlinico Umberto I
🇮🇹Roma, Italy
Policlinico A. Gemelli IRCCS
🇮🇹Rome, Italy
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
🇯🇵Himeji-shi, Hyogo, Japan
Kokura Memorial Hospital, Cardiology
🇯🇵Kitakyushu-shi,Fukuoka, Japan
Omihachiman Community Medical Center_Omihachiman-shi, Siga
🇯🇵Omihachiman-shi, Siga, Japan
Osaka City General Hospital
🇯🇵Osaka, Japan
Hanaoka Seishu Memorial Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
🇯🇵Tokyo, Japan
Rode Kruis Ziekenhuis Beverwijk
🇳🇱Beverwijk, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Saxenburgh Medisch Centrum
🇳🇱Hardenberg, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Bravis Ziekenhuis
🇳🇱Roosendaal, Netherlands
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
🇵🇱Lodz, Lodzkie, Poland
Malopolskie Centrum Sercowo-Naczyniowe
🇵🇱Chrzanow, Malopolskie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
🇵🇱Bialystok, Podlaskie, Poland
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
🇵🇱Gdynia, Poland
I Katedra i Klinika Kardiologii WUM SPCSK
🇵🇱Warsaw, Poland
Pro Familia Altera Sp. z o.o.
🇵🇱Katowice, Śląskie, Poland
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
ClÃnica Nuevas TecnologÃas en Diabetes y EndocrinologÃa
🇪🇸Sevilla, Spain
Hospital ClÃnico Universitario de Valencia
🇪🇸Valencia, Spain
Dept of Med Sahlgrenska/Östra
🇸🇪Göteborg, Sweden
Hjärtmottagningen
🇸🇪Uppsala, Sweden
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Glasgow Clinical Research Facility
🇬🇧Glasgow, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, United Kingdom
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
Manchester Royal Infirmary_Manchester_0
🇬🇧Manchester, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
Selye János Kórház
ðŸ‡ðŸ‡ºKomárom, Komárom-Esztergom, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Semmelweis Egyetem Szent Rókus Klinikai Tömb
ðŸ‡ðŸ‡ºBudapest, Hungary
Gottsegen György Országos Kardiológiai Intézet
ðŸ‡ðŸ‡ºBudapest, Hungary
Semmelweis Egyetem Városmajori SzÃv- és Érgyógyászat
ðŸ‡ðŸ‡ºBudapest, Hungary
Jahn Ferenc Dél-pesti Kórház és Rendelőintézet
ðŸ‡ðŸ‡ºBudapest, Hungary
DE KK Kardiológiai és SzÃvsebészeti klinika
ðŸ‡ðŸ‡ºDebrecen, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház
ðŸ‡ðŸ‡ºMiskolc, Hungary
Zala Megyei Szent Rafael Kórház
ðŸ‡ðŸ‡ºZalaegerszeg, Hungary
G B Pant Institute of Postgraduate Medical Education and Research
🇮🇳New Delhi, Delhi, India
Max Super Speciality Hospital, Saket
🇮🇳New Delhi, Delhi, India
Lisie Hospital
🇮🇳Kochi, Kerala, India
Vijan Cardiac & Critical Care
🇮🇳Nashik, Maharashtra, India
Vijan Hospital & Research Centre
🇮🇳Nashik, Maharashtra, India
VMMC & Safdarjung Hospital
🇮🇳New Dehli, New Delhi, India
SP Medical College & A.G.Hospital Bikaner
🇮🇳Bikaner, Rajasthan, India
SP Medical College
🇮🇳Bikaner, Rajasthan, India
Apollo Hospitals Education & Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Northwest Heart Clin. Res.
🇺🇸Arlington Heights, Illinois, United States
MVZ "Am Felsenkeller" (Dresden)
🇩🇪Dresden, Germany
University of Leipzig - Kardiologie
🇩🇪Leipzig, Germany
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
🇩🇪Würzburg, Germany
Eastern Shore Rsrch Inst, LLC
🇺🇸Fairhope, Alabama, United States
Keck Medical Center of USC - Outpatient Clinic
🇺🇸Los Angeles, California, United States
Baptist Heart Specialists_Jacksonville
🇺🇸Jacksonville, Florida, United States
Chicago Medical Research LLC
🇺🇸Hazel Crest, Illinois, United States
Ascension St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
Cotton-O'Neil Heart Center
🇺🇸Topeka, Kansas, United States
Baptist Health Woodland
🇺🇸Elizabethtown, Kentucky, United States
Baptist Health Louisville
🇺🇸Louisville, Kentucky, United States
Grace Research, LLC
🇺🇸Bossier City, Louisiana, United States
Grace Research, LLC_Shreveport
🇺🇸Shreveport, Louisiana, United States
John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
St Louis Heart & Vascular, P.C.
🇺🇸Saint Louis, Missouri, United States
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
CHI Health Clinic Cardiology (CUMC - Bergan Mercy)
🇺🇸Omaha, Nebraska, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
CEMEDIC
🇦🇷Caba, Argentina
Instituto de CardiologÃa de Corrientes
🇦🇷Corrientes, Argentina
Centro de Investigación y Prevención Cardiovascular
🇦🇷Caba, Argentina
CardiologÃa Palermo
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Consultorio Integral de Atención al Diabético
🇦🇷Morón, Argentina
Sanatorio Britanico S.A.
🇦🇷Rosario, Santa Fe, Argentina
Krankenhaus St. Josef Braunau
🇦🇹Braunau, Austria
Medizinische Universität Graz
🇦🇹Graz, Austria
Fließer-Görzer [Ordination]
🇦🇹Saint Stefan, Austria
Imed 19- privat
🇦🇹Wien, Austria
Universitätsklinik für Innere Medizin II
🇦🇹Wien, Austria
University of Calgary_Calgary
🇨🇦Calgary, Alberta, Canada
Cambridge Cardiac Care Centre
🇨🇦Cambridge, Ontario, Canada
Partnrs Adv Cardio Eval (PACE)
🇨🇦Newmarket, Ontario, Canada
Heart Health Institute Research, Inc.
🇨🇦Scarborough, Ontario, Canada
Ctr de Med Metab de Lanaudiere
🇨🇦Terrebonne, Quebec, Canada
Institut universitaire de cardiologie
🇨🇦Quebec, Canada
Edumed Broumov
🇨🇿Broumov, Czechia
Fakultnà poliklinika VFN ambulance Srdecniho selhani
🇨🇿Praha 2, Czechia
IKEM
🇨🇿Praha 4, Czechia
Poliklinika Holešovice VISIONARY - MEDICON a.s.
🇨🇿Praha 7, Czechia
Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.
🇨🇿Praha 7, Czechia
Charite Universitatsmedizin Berlin KöR
🇩🇪Berlin, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
🇩🇪Elsterwerda, Germany
MVZ CCB Frankfurt Und Main-Taunus GbR
🇩🇪Frankfurt, Germany
Medical Center - University Of Freiburg
🇩🇪Freiburg, Germany
Lausmed Kft.
ðŸ‡ðŸ‡ºBaja, Bács-Kiskun Vármegye, Hungary