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Clinical Trial Details

Trial ID: L5468
Source ID: NCT04916470
Associated Drug: Semaglutide
Title: Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
Acronym: STEP HFpEF DM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Placebo (Semaglutide)
Outcome Measures: Primary: 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: Change in 6-minute walking distance, Measured in metres, From baseline (week 0) to end of treatment (week 52)|Hierarchical composite of time to all-cause death, Measured as total wins for each treatment group., 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, Measured as total wins for each treatment group, 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, Measured as total wins for each treatment group., 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, Measured as total wins for each treatment group., From baseline (week 0) to end of study (week 57)|Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks, Measured as total wins for each treatment group., From baseline (week 0) to end of study (week 57)|Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks, Measured as total wins for each treatment group., From baseline (week 0) to end of study (week 57)|Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio), Measured as total wins for each treatment group., From baseline (week 0) to end of study (week 57)|Change in C-Reactive Protein, Presented as ratio to baseline, From baseline (week -2) to end of treatment (week 52)|Participant achieving 10% weight loss or more (Yes/No), Count of participants, From baseline (week 0) to end of treatment (week 52)|Participant achieving 15% weight loss or more (Yes/No), Count of participants, From baseline (week 0) to end of treatment (week 52)|Participant achieving 20% weight loss or more (Yes/No), Count of participants, From baseline (week 0) to end of treatment (week 52)|Participant improving 5 points or more in KCCQ clinical summary score, Count of participants, From baseline (week 0) to end of treatment (week 52)|Participant improving 10 points or more in KCCQ clinical summary score (Yes/No), Count of participants, From baseline (week 0) to end of treatment (week 52)|Change in KCCQ overall 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)|Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS, Count of participants, From baseline (week 0) to end of treatment (week 52)|Participant achieving threshold for clinically meaningful within-subject change in 6MWD, Count of participants, From baseline (week 0) to end of treatment (week 52)|Change in waist circumference, Measured in centimetre (cm), From baseline (week 0) to end of treatment (visit 52)|Change in systolic blood pressure, Measured in millimetre of mercury (mmHg), From baseline (week -2) to end of treatment (week 52)|Change in glycated haemoglobin (HbA1c), Measured in percentage (%)-point, From baseline (week 0) to end of treatment (week 52)|Number of treatment emergent severe or clinically significant hypoglycaemia episodes, Count of events, From baseline (week 0) to end of trial (week 57)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 617
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-06-15
Completion Date: 2023-10-11
Results First Posted:
Last Update Posted: 2024-10-09
Locations: Eastern Shore Rsrch Inst, LLC, Fairhope, Alabama, 36532, United States|Keck Medical Center of USC - Outpatient Clinic, Los Angeles, California, 90033, United States|Baptist Heart Specialists_Jacksonville, Jacksonville, Florida, 32258, United States|Northwest Heart Clin. Res., Arlington Heights, Illinois, 60005, United States|Chicago Medical Research LLC, Hazel Crest, Illinois, 60429, United States|Ascension St. Vincent Medical Group, Indianapolis, Indiana, 46260, United States|Cotton-O'Neil Heart Center, Topeka, Kansas, 66606, United States|Baptist Health Woodland, Elizabethtown, Kentucky, 42701, United States|Baptist Health Louisville, Louisville, Kentucky, 40207, United States|Grace Research, LLC, Bossier City, Louisiana, 71111, United States|Grace Research, LLC_Shreveport, Shreveport, Louisiana, 71105, United States|John Hopkins Hospital, Baltimore, Maryland, 21287, 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., Saint Louis, Missouri, 63136, United States|Bryan Heart, Lincoln, Nebraska, 68506, United States|CHI Health Clinic Cardiology (CUMC - Bergan Mercy), Omaha, Nebraska, 68124, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Wake Forest Baptist Health, Winston-Salem, North Carolina, 27157, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, 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|Instituto de Cardiología de Corrientes, Corrientes, Buenos Aires, W3400AMZ, 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, 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, A 5280, Austria|Medizinische Universität Graz, Graz, A 8036, Austria|Fließer-Görzer [Ordination], Saint Stefan, 8511, Austria|Imed 19- privat, Wien, 1190, Austria|Universitätsklinik für Innere Medizin II, Wien, A 1090, Austria|University of Calgary_Calgary, Calgary, Alberta, T2N 4Z6, Canada|Cambridge Cardiac Care Centre, Cambridge, Ontario, N1R 6V6, Canada|Partnrs Adv Cardio Eval (PACE), Newmarket, Ontario, L3Y 2P6, Canada|Heart Health Institute Research, Inc., Scarborough, Ontario, M1B 4Z8, Canada|Ctr de Med Metab de Lanaudiere, Terrebonne, Quebec, J6X 4P7, Canada|Institut universitaire de cardiologie, Quebec, G1V 4G5, Canada|Edumed Broumov, Broumov, 550 01, Czechia|Fakultní poliklinika VFN ambulance Srdecniho selhani, Praha 2, 120 00, Czechia|IKEM, Praha 4, 140 21, Czechia|Poliklinika Holešovice VISIONARY - MEDICON a.s., Praha 7, 170 00, Czechia|Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o., Praha 7, 170 00, Czechia|Charite Universitatsmedizin Berlin KöR, Berlin, 13353, Germany|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, 79106, Germany|University of Leipzig - Kardiologie, Leipzig, 04103, Germany|Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz, Würzburg, 97078, Germany|Lausmed Kft., Baja, Bács-Kiskun Vármegye, 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|G B Pant Institute of Postgraduate Medical Education and Research, New Delhi, Delhi, 110002, India|Max Super Speciality Hospital, Saket, New Delhi, Delhi, 110017, India|Lisie Hospital, Kochi, Kerala, 682018, India|Vijan Cardiac & Critical Care, Nashik, Maharashtra, 422005, India|Vijan Hospital & Research Centre, Nashik, Maharashtra, 422005, 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|Max Super Speciality Hospital_New Delhi, New Delhi, 110017, India|Sir Ganga Ram Hospital, New Delhi, 110060, India|Hadassah Ein Kerem MC - Cardio, Jerusalem, 91120, Israel|Cardiology department, Western Galilee Medical Center, Nahariya, 22100, Israel|Heart Failure Unit, Rabin Medical Center - Beilinson Campus, Petah-Tikva, 49100, Israel|Cardio Vascular Research Center Sourasky MC, Tel Aviv, 6423906, Israel|Sheba Medica Center - Clinical Research Unit, Tel Hashomer, 5265601, Israel|ASST Papa Giovanni XXIII, Bergamo, Bg, 24127, Italy|Spedali Civili Brescia, Brescia, Bs, 25123, Italy|A.O.U. Ferrara, Sant'Anna, Cona (Ferrara), Fe, 44124, Italy|Centro Cardiologico Monzino. Istituto di Ricovero e Cura, Milano, 20138, 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|Omihachiman Community Medical Center_Omihachiman-shi, Siga, Omihachiman-shi, Siga, 523-0082, Japan|Osaka City General Hospital, Osaka, 534-0021, Japan|Hanaoka Seishu Memorial Hospital, Sapporo-shi, Hokkaido, 062-0003, Japan|Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai, Tokyo, 140-8522, Japan|Rode Kruis Ziekenhuis Beverwijk, Beverwijk, 1942 LE, Netherlands|UMC Groningen, Groningen, 9713 GZ, Netherlands|Saxenburgh Medisch Centrum, Hardenberg, 7772 SE, Netherlands|Medisch Centrum Leeuwarden, Leeuwarden, 8934 AD, Netherlands|Bravis Ziekenhuis, Roosendaal, 4708 AE, Netherlands|Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow, Lodz, Lodzkie, 90-549, Poland|Malopolskie Centrum Sercowo-Naczyniowe, Chrzanow, Malopolskie, 32-500, Poland|Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio, Bialystok, Podlaskie, 15-276, Poland|Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman, Gdynia, 81-157, Poland|I Katedra i Klinika Kardiologii WUM SPCSK, Warsaw, 02-097, Poland|Pro Familia Altera Sp. z o.o., Katowice, Śląskie, 40-648, Poland|Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, 15706, Spain|Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Dept of Med Sahlgrenska/Östra, Göteborg, 416 50, Sweden|Hjärtmottagningen, Uppsala, 751 85, Sweden|Ninewells Hospital, Dundee, DD1 9SY, United Kingdom|Glasgow Clinical Research Facility, Glasgow, G31 2ER, United Kingdom|Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom|Wycombe General Hospital, High Wycombe, HP11 2TT, United Kingdom|University Hospital Aintree, Liverpool, L9 7AL, United Kingdom|Manchester Royal Infirmary_Manchester_0, Manchester, M13 9WL, United Kingdom|Great Western Hospital, Swindon, SN3 6BB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04916470

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress