Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
STEP HFpEF DM
Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes
3 other identifiers
interventional
617
16 countries
180
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2021
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2023
CompletedNovember 26, 2025
November 1, 2025
2.3 years
June 1, 2021
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.
From baseline (week 0) to end of treatment (week 52)
Change in body weight
Percentage (%)
From baseline (week 0) to end of treatment (week 52)
Secondary Outcomes (21)
Change in 6-minute walking distance
From baseline (week 0) to end of treatment (week 52)
Hierarchical composite of time to all-cause death
From baseline (week 0) to end of study (week 57)
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)
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)
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)
- +16 more secondary outcomes
Study Arms (2)
Semaglutide 2.4 mg once weekly (OW)
EXPERIMENTALParticipants will receive semaglutide injections for 52 weeks.
Semaglutide placebo OW
PLACEBO COMPARATORParticipants will receive semaglutide placebo injections for 52 weeks.
Interventions
Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.
Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (180)
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama, 36532, United States
Mobile Heart Specialists
Mobile, Alabama, 36608, United States
National Heart Institute Cal
Beverly Hills, California, 90211, United States
John Muir Physicians Network
Concord, California, 94520, United States
Valley Clinical Trials
Covina, California, 91723, United States
Keck Medical Center of USC - Outpatient Clinic
Los Angeles, California, 90033, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Lundquist Inst-Biomed Innovtn
Torrance, California, 90502, United States
New West Physicians,Inc.
Golden, Colorado, 80401, United States
Excel Med Ctr Clinical Trials
Boca Raton, Florida, 33434, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511, United States
Baptist Heart Specialists_Jacksonville
Jacksonville, Florida, 32258, United States
CV Res Ctr of S Florida
Miami, Florida, 33173, United States
Endeavor Health Clinical Operations-NCH
Arlington Heights, Illinois, 60005, United States
Endeavor Health Glenbook Hosp
Evanston, Illinois, 60201, United States
Northwestern University_Chicago_0
Evanston, Illinois, 60208, United States
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429, United States
Deaconess Specialty Physicians
Evansville, Indiana, 47747, United States
Ascension St. Vincent Medical Group
Indianapolis, Indiana, 46260, United States
Cardiovascular Rsrch of NW_IN
Munster, Indiana, 46321, United States
Cotton-O'Neil Heart Center
Topeka, Kansas, 66606, United States
Baptist Health Woodland
Elizabethtown, Kentucky, 42701, United States
The Research Group of Lexington LLC
Lexington, Kentucky, 40503, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Grace Research, LLC
Bossier City, Louisiana, 71111, United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403, United States
Clinical Trials of Ame, LLC
Monroe, Louisiana, 71201, United States
Grace Research, LLC_Shreveport
Shreveport, Louisiana, 71105, United States
Louisiana Heart Center_Slidell
Slidell, Louisiana, 70458, United States
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, 21229, United States
MedStar Good Samaritan Hosp
Baltimore, Maryland, 21239, United States
John Hopkins Hospital
Baltimore, Maryland, 21287, United States
Elite Research Center
Flint, Michigan, 48532, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39216, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
St Louis Heart & Vascular, P.C.
St Louis, Missouri, 63136, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
CHI Health Clinic Cardiology (CUMC - Bergan Mercy)
Omaha, Nebraska, 68124, United States
St Francis Hospital Lindner Research Center
Greenvale, New York, 11548, United States
NY Presbyt Hosp-W Cornell Med
New York, New York, 10021, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Lindner Center,Christ Hospital
Cincinnati, Ohio, 45219, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sanford Health_Sioux Falls
Sioux Falls, South Dakota, 57117, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Angio Cardiac Care of Texas
Houston, Texas, 77025, United States
Cardiology Consultants of Danville Inc.
Danville, Virginia, 24541, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-5058, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
CEMEDIC
CABA, Buenos Aires, C1440CFD, Argentina
Centro de Investigación y Prevención Cardiovascular
CABA, C1061AAS., Argentina
Centro de Investigación y Prevención Cardiovascular
CABA, C1119ACN, Argentina
CEMEDIC
CABA, C1440CFD, Argentina
Cardiología Palermo Duplicate
Ciudad Autónoma de Buenos Aire, 1425, Argentina
Cardiología Palermo
Ciudad Autónoma de Buenos Aire, 1425, Argentina
Instituto de Cardiología de Corrientes
Corrientes, W3400AMZ, Argentina
Consultorio Integral de Atención al Diabético
Morón, B1708IFF, Argentina
Sanatorio Britanico S.A.
Rosario, Santa Fe, S2000CVB, Argentina
Krankenhaus St. Josef Braunau
Braunau am Inn, 5280, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Graz
Graz, A 8036, Austria
Fließer-Görzer [Ordination]
Saint Stefan, 8511, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Klinik Favoriten
Vienna, 1100, Austria
Imed 19- privat
Vienna, 1190, Austria
AKH Universitätsklinik für Innere Medizin II
Vienna, A 1090, Austria
Universitätsklinik für Innere Medizin II
Vienna, A 1090, Austria
University of Calgary_Calgary
Calgary, Alberta, T2N 4Z6, Canada
Univ of Alberta Hosp Edmonton
Edmonton, Alberta, T6G 2B7, Canada
North Shore Heart Centre
North Vancouver, British Columbia, V7M 2H4, Canada
SMH Cardiology Clinical Trials Inc.
Surrey, British Columbia, V3V 0C6, Canada
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2HA6, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
Partnrs Adv Cardio Eval (PACE)
Newmarket, Ontario, L3Y 2P6, Canada
Oakville Cardiovascular Research LP
Oakville, Ontario, L6K 3W7, Canada
Heart Health Institute Research, Inc.
Scarborough Village, Ontario, M1B 4Z8, Canada
Dr. Louis Yao
Weston, Ontario, M9N 1W4, Canada
ViaCar Recherche Clinique Inc
Brossard, Quebec, J4Z 2K9, Canada
Applied Med Inf Res
Montreal, Quebec, H4A 3T2, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, J6X 4P7, Canada
Institut universitaire de cardiologie
Québec, G1V 4G5, Canada
Edumed Broumov
Broumov, 550 01, Czechia
Fakultní poliklinika VFN ambulance Srdecniho selhani
Prague, 120 00, Czechia
IKEM
Prague, 140 21, Czechia
MEDICON a.s.
Prague, 170 00, Czechia
Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.
Prague, 170 00, Czechia
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
Berlin, 13353, Germany
Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
Dresden, 01277, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, 60389, Germany
Medical Center - University Of Freiburg
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Freiburg - Medical Center
Freiburg im Breisgau, 79106, Germany
B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH
Kassel, 34121, Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie
Leipzig, 04103, Germany
Universitätsmedizin Mainz, Kardiologie I, Studienzentrum
Mainz, 55131, Germany
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
Würzburg, 97078, Germany
Lausmed Kft.
Baja, Bács-Kiskun county, 6500, Hungary
Selye János Kórház
Komárom, Komárom-Esztergom, 2921, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, 1032, Hungary
Semmelweis Egyetem Szent Rókus Klinikai Tömb
Budapest, 1085, Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, 1096, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
Budapest, 1122, Hungary
Jahn Ferenc Dél-pesti Kórház és Rendelőintézet
Budapest, 1204, Hungary
DE KK Kardiológiai és Szívsebészeti klinika
Debrecen, 4032, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház
Miskolc, 3526, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, 8900, Hungary
Krishna Institute of medical sciences Ltd
Secunderabad, A.P., 500 003, India
CIMS- Care Institute of Medical Sciences
Ahmedabad, Gujarat, 380060, India
Rhythm Heart Institute
Vadodara, Gujarat, 390022, India
K R Hospital
Mysore, Karnataka, 570001, India
Lisie Hospital
Kochi, Kerala, 682018, India
Vijan Cardiac & Critical Care
Nashik, Maharashtra, 422005, India
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005, India
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, 110002, India
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, 110017, India
Batra Hospital and Medical Research Center
New Delhi, National Capital Territory of Delhi, 110062, India
VMMC & Safdarjung Hospital
New Dehli, New Delhi, 110029, India
SP Medical College & A.G.Hospital Bikaner
Bikaner, Rajasthan, 334003, India
SP Medical College
Bikaner, Rajasthan, 334003, India
Apollo Hospitals Education & Research Foundation
Chennai, Tamil Nadu, 600006, India
Gandhi Memorial Hospital- King George's Medical University
Lucknow, Uttar Pradesh, 226003, India
G B Pant Institute of Postgraduate Medical Education and Res
New Delhi, 110002, India
Dr. BL Kapur Memorial Hospital
New Delhi, 110005, India
Max Super Speciality Hospital_New Delhi
New Delhi, 110017, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Hadassah Ein Karam MC - Cardio Department
Jerusalem, 91120, Israel
Western Galilee MC - Cardiology Department
Nahariya, 22100, Israel
Rabin MC Beilinson - Heart Failure Unit
Petah Tikva, 49100, Israel
Sourasky MC - Cardio Vascular Research Center
Tel Aviv, 6423906, Israel
Sheba MC - Cardiology Clinical Research Unit
Tel Litwinsky, 5265601, Israel
Spedali Civili Brescia
Brescia, Bs, 25123, Italy
A.O.U. Ferrara, Sant'Anna
Cona (Ferrara), Fe, 44124, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, 24127, Italy
Centro Cardiologico Monzino
Milan, 20138, Italy
Azienda Ospedaliera di Padova - MASTER
Padua, 35128, Italy
A.O.U. Policlinico Umberto I
Roma, 00161, Italy
Policlinico A. Gemelli IRCCS
Rome, 00168, Italy
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
Himeji-shi, Hyogo, 670-8560, Japan
Kokura Memorial Hospital_Cardiology
Kitakyushu-shi,Fukuoka, 802-8555, Japan
Okayama University Hospital_Cardiovascular Medicine
Okayama-shi, Okayama, 700-8558, Japan
Omihachiman Community Medical Center_Omihachiman-shi, Siga
Omihachiman-shi, Siga, 523-0082, Japan
Osaka City General Hospital_Endocrinology and Diabetes Mellitus
Osaka, 534-0021, Japan
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
Osaka-shi, Osaka, 530-8480, Japan
Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine
Sapporo-shi, Hokkaido, 062-0003, Japan
Tokyo Shinagawa Hospital_Cardiovascular Medicine
Tokyo, 140-8522, Japan
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, 7334 DZ, Netherlands
Rijnstate Ziekenhuis
Arnhem, 6815 AD, Netherlands
Rode Kruis Ziekenhuis Beverwijk
Beverwijk, 1942 LE, Netherlands
UMC Groningen
Groningen, 9713 GZ, Netherlands
Saxenburgh Medisch Centrum
Hardenberg, 7772 SE, Netherlands
Frisius MC Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Bravis Ziekenhuis
Roosendaal, 4708 AE, Netherlands
Malopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, 32-500, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
Bialystok, Podlaskie Voivodeship, 15-540, Poland
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
Gdynia, Pomeranian Voivodeship, 81-157, Poland
Pro Familia Altera Sp. z o.o.
Katowice, Silesian Voivodeship, 40-648, Poland
I Katedra i Klinika Kardiologii WUM SPCSK
Warsaw, 02-097, Poland
Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi
Lodz, Łódź Voivodeship, 90-549, Poland
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Dept of Med Sahlgrenska/Östra
Gothenburg, 416 50, Sweden
Medicinkliniken Ryhov
Jönköping, 551 85, Sweden
Hjärtmottagningen
Uppsala, 751 85, Sweden
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Glasgow Clinical Research Facility
Glasgow, G31 2ER, United Kingdom
Glasgow Royal Infirmary
Glasgow, G31 2ER, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Wycombe General Hospital
High Wycombe, HP11 2TT, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
University Hospital Aintree
Liverpool, L9 7AL, United Kingdom
Manchester Royal Infirmary_Manchester_0
Manchester, M13 9WL, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Great Western Hospital
Swindon, SN3 6BB, United Kingdom
Related Publications (13)
Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J, Christensen L, Davies M, Hovingh KG, Kitzman DW, Lindegaard ML, Moller DV, Shah SJ, Treppendahl MB, Verma S, Petrie MC. Design and Baseline Characteristics of STEP-HFpEF Program Evaluating Semaglutide in Patients With Obesity HFpEF Phenotype. JACC Heart Fail. 2023 Aug;11(8 Pt 1):1000-1010. doi: 10.1016/j.jchf.2023.05.010. Epub 2023 May 21.
PMID: 37294245BACKGROUNDBorlaug BA, Kitzman DW, Patel S, Chinnakondepalli KM, Butler J, Davies MJ, Petrie MC, Shah SJ, Verma S, Nunez J, Einfeldt MN, Liisberg K, Salsali A, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide and Exercise Function in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program. JACC Heart Fail. 2025 Nov;13(11):102660. doi: 10.1016/j.jchf.2025.102660. Epub 2025 Oct 3.
PMID: 41045908DERIVEDPandey A, Kitzman DW, Chinnakondepalli KM, Patel S, Borlaug BA, Butler J, Davies MJ, Shah SJ, Verma S, Ronnback C, Domdey A, Liisberg K, Schou M, Perna E, Ahmed FZ, Fu M, Petrie MC, Kosiborod MN. Frailty and Effects of Semaglutide in Obesity-Related HFpEF: Findings From the STEP-HFpEF Program. JACC Heart Fail. 2025 Oct;13(10):102610. doi: 10.1016/j.jchf.2025.102610. Epub 2025 Sep 15.
PMID: 40956259DERIVEDDavies MJ, van der Meer P, Verma S, Patel S, Chinnakondepalli KM, Borlaug BA, Butler J, Kitzman DW, Shah SJ, Harring S, Salsali A, Rasmussen S, von Lewinski D, Abhayaratna W, Petrie MC, Kosiborod MN; STEP-HFpEF Trials Committees and Investigators. Semaglutide in obesity-related heart failure with preserved ejection fraction and type 2 diabetes across baseline HbA1c levels (STEP-HFpEF DM): a prespecified analysis of heart failure and metabolic outcomes from a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2025 Mar;13(3):196-209. doi: 10.1016/S2213-8587(24)00304-8. Epub 2025 Jan 20.
PMID: 39848268DERIVEDKosiborod MN, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC, Plutzky J, Rasmussen S, Ronnback C, Shah SJ, Verma S, Weeke PE, Lincoff AM; SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM Trial Committees and Investigators. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024 Sep 7;404(10456):949-961. doi: 10.1016/S0140-6736(24)01643-X. Epub 2024 Aug 30.
PMID: 39222642DERIVEDSolomon SD, Ostrominski JW, Wang X, Shah SJ, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Verma S, Abildstrom SZ, Nygaard Einfeldt M, Rasmussen S, Abhayaratna WP, Ahmed FZ, Ben-Gal T, Chopra V, Ito H, Merkely B, Nunez J, Senni M, van der Meer P, Wolf D, Petrie MC, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure. J Am Coll Cardiol. 2024 Oct 22;84(17):1587-1602. doi: 10.1016/j.jacc.2024.08.021. Epub 2024 Aug 30.
PMID: 39217567DERIVEDVerma S, Butler J, Borlaug BA, Davies MJ, Kitzman DW, Petrie MC, Shah SJ, Jensen TJ, Rasmussen S, Ronnback C, Merkely B, O'Keefe E, Kosiborod MN; STEP-HFpEF and STEP-HFpEF DM Investigators. Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Program. J Am Coll Cardiol. 2024 Oct 22;84(17):1603-1614. doi: 10.1016/j.jacc.2024.08.023. Epub 2024 Aug 30.
PMID: 39217565DERIVEDVerma S, Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Ronnback C, Abildstrom SZ, Liisberg K, Wolf D, von Lewinski D, Lelonek M, Melenovsky V, Senni M, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Inflammation in Obesity-Related HFpEF: The STEP-HFpEF Program. J Am Coll Cardiol. 2024 Oct 22;84(17):1646-1662. doi: 10.1016/j.jacc.2024.08.028. Epub 2024 Aug 30.
PMID: 39217564DERIVEDSchou M, Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Verma S, Patel S, Chinnakondepalli KM, Harring S, Abildstrom SZ, Liisberg K, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction: The STEP-HFpEF Program. J Am Coll Cardiol. 2024 Jul 16;84(3):247-257. doi: 10.1016/j.jacc.2024.04.038. Epub 2024 Jun 23.
PMID: 38913004DERIVEDVerma S, Butler J, Borlaug BA, Davies M, Kitzman DW, Shah SJ, Petrie MC, Barros E, Ronnback C, Vestergaard LS, Schou M, Ezekowitz JA, Sharma K, Patel S, Chinnakondepalli KM, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Trials. J Am Coll Cardiol. 2024 Aug 27;84(9):773-785. doi: 10.1016/j.jacc.2024.06.001. Epub 2024 Jun 23.
PMID: 38913003DERIVEDShah SJ, Sharma K, Borlaug BA, Butler J, Davies M, Kitzman DW, Petrie MC, Verma S, Patel S, Chinnakondepalli KM, Einfeldt MN, Jensen TJ, Rasmussen S, Asleh R, Ben-Gal T, Kosiborod MN. Semaglutide and diuretic use in obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF-DM trials. Eur Heart J. 2024 Sep 14;45(35):3254-3269. doi: 10.1093/eurheartj/ehae322.
PMID: 38739118DERIVEDButler J, Shah SJ, Petrie MC, Borlaug BA, Abildstrom SZ, Davies MJ, Hovingh GK, Kitzman DW, Moller DV, Verma S, Einfeldt MN, Lindegaard ML, Rasmussen S, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials. Lancet. 2024 Apr 27;403(10437):1635-1648. doi: 10.1016/S0140-6736(24)00469-0. Epub 2024 Apr 7.
PMID: 38599221DERIVEDKosiborod MN, Petrie MC, Borlaug BA, Butler J, Davies MJ, Hovingh GK, Kitzman DW, Moller DV, Treppendahl MB, Verma S, Jensen TJ, Liisberg K, Lindegaard ML, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, Shah SJ; STEP-HFpEF DM Trial Committees and Investigators. Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes. N Engl J Med. 2024 Apr 18;390(15):1394-1407. doi: 10.1056/NEJMoa2313917. Epub 2024 Apr 6.
PMID: 38587233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (Dept.1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 7, 2021
Study Start
June 15, 2021
Primary Completion
October 11, 2023
Study Completion
October 11, 2023
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com