Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM)

November 24, 2025 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1061AAS.
        • Centro de Investigación y Prevención Cardiovascular
      • CABA, Argentina, C1119ACN
        • Centro de Investigación y Prevención Cardiovascular
      • CABA, Argentina, C1440CFD
        • CEMEDIC
      • Ciudad Autónoma de Buenos Aire, Argentina, 1425
        • Cardiología Palermo
      • Ciudad Autónoma de Buenos Aire, Argentina, 1425
        • Cardiología Palermo Duplicate
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiologia de Corrientes
      • Morón, Argentina, B1708IFF
        • Consultorio Integral de Atención al Diabético
      • Rosario, Santa Fe, Argentina, S2000CVB
        • Sanatorio Britanico S.A.
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1440CFD
        • CEMEDIC
  • Austria
      • Braunau am Inn, Austria, 5280
        • Krankenhaus St. Josef Braunau
      • Graz, Austria, 8036
        • Medizinische Universitat Graz
      • Graz, Austria, A 8036
        • Medizinische Universitat Graz
      • Saint Stefan, Austria, 8511
        • Fließer-Görzer [Ordination]
      • Vienna, Austria, 1090
        • Medizinische Universitat Wien
      • Vienna, Austria, 1100
        • Klinik Favoriten
      • Vienna, Austria, 1190
        • Imed 19- privat
      • Vienna, Austria, A 1090
        • Universitätsklinik für Innere Medizin II
      • Vienna, Austria, A 1090
        • AKH Universitätsklinik für Innere Medizin II
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut universitaire de cardiologie
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary_Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • Univ of Alberta Hosp Edmonton
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7M 2H4
        • North Shore Heart Centre
      • Surrey, British Columbia, Canada, V3V 0C6
        • SMH Cardiology Clinical Trials Inc.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2HA6
        • St. Boniface Hospital
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cambridge Cardiac Care Centre
      • Newmarket, Ontario, Canada, L3Y 2P6
        • Partnrs Adv Cardio Eval (PACE)
      • Oakville, Ontario, Canada, L6K 3W7
        • Oakville Cardiovascular Research LP
      • Scarborough Village, Ontario, Canada, M1B 4Z8
        • Heart Health Institute Research, Inc.
      • Weston, Ontario, Canada, M9N 1W4
        • Dr. Louis Yao
    • Quebec
      • Brossard, Quebec, Canada, J4Z 2K9
        • ViaCar Recherche Clinique Inc
      • Montreal, Quebec, Canada, H4A 3T2
        • Applied Med Inf Res
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Ctr de Med Metab de Lanaudiere
  • Czechia
      • Broumov, Czechia, 550 01
        • Edumed Broumov
      • Prague, Czechia, 140 21
        • IKEM
      • Prague, Czechia, 120 00
        • Fakultní poliklinika VFN ambulance Srdecniho selhani
      • Prague, Czechia, 170 00
        • Medicon a.s.
      • Prague, Czechia, 170 00
        • Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.
  • Germany
      • Berlin, Germany, 13353
        • Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
      • Dresden, Germany, 01277
        • Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden)
      • Elsterwerda, Germany, 04910
        • Zentrum fuer Klinische Studien Suedbrandenburg GmbH
      • Frankfurt, Germany, 60389
        • MVZ CCB Frankfurt und Main-Taunus GbR
      • Freiburg im Breisgau, Germany, 79106
        • Medical Center - University of Freiburg
      • Freiburg im Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg - Medical Center
      • Kassel, Germany, 34121
        • B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz, Kardiologie I, Studienzentrum
      • Würzburg, Germany, 97078
        • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
  • Hungary
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
      • Budapest, Hungary, 1096
        • Gottsegen György Országos Kardiológiai Intézet
      • Budapest, Hungary, 1032
        • Szent Margit Rendelőintézet Nonprofit Kft.
      • Budapest, Hungary, 1122
        • Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem Szent Rókus Klinikai Tömb
      • Debrecen, Hungary, 4032
        • DE KK Kardiológiai és Szívsebészeti klinika
      • Miskolc, Hungary, 3526
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Szent Rafael Kórház
    • Bács-Kiskun county
      • Baja, Bács-Kiskun county, Hungary, 6500
        • Lausmed Kft.
    • Komárom-Esztergom
      • Komárom, Komárom-Esztergom, Hungary, 2921
        • Selye János Kórház
  • India
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110005
        • Dr. BL Kapur Memorial Hospital
      • New Delhi, India, 110002
        • G B Pant Institute of Postgraduate Medical Education and Res
      • New Delhi, India, 110017
        • Max Super Speciality Hospital_New Delhi
    • A.P.
      • Secunderabad, A.P., India, 500 003
        • Krishna Institute of medical sciences Ltd
    • Gujarat
      • Ahmedabad, Gujarat, India, 380060
        • CIMS- Care Institute of Medical Sciences
      • Vadodara, Gujarat, India, 390022
        • Rhythm Heart Institute
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • K R Hospital
    • Kerala
      • Kochi, Kerala, India, 682018
        • Lisie Hospital
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
        • Vijan Hospital & Research Centre
      • Nashik, Maharashtra, India, 422005
        • Vijan Cardiac & Critical Care
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Max Super Speciality Hospital, Saket
      • New Delhi, National Capital Territory of Delhi, India, 110002
        • G B Pant Institute of Postgraduate Medical Education and Research
      • New Delhi, National Capital Territory of Delhi, India, 110062
        • Batra Hospital and Medical Research Center
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • VMMC & Safdarjung Hospital
    • Rajasthan
      • Bikaner, Rajasthan, India, 334003
        • SP Medical College
      • Bikaner, Rajasthan, India, 334003
        • SP Medical College & A.G.Hospital Bikaner
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Apollo Hospitals Education & Research Foundation
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Gandhi Memorial Hospital- King George's Medical University
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Ein Karam MC - Cardio Department
      • Nahariya, Israel, 22100
        • Western Galilee MC - Cardiology Department
      • Petah Tikva, Israel, 49100
        • Rabin MC Beilinson - Heart Failure Unit
      • Tel Aviv, Israel, 6423906
        • Sourasky MC - Cardio Vascular Research Center
      • Tel Litwinsky, Israel, 5265601
        • Sheba MC - Cardiology Clinical Research Unit
  • Italy
      • Milan, Italy, 20138
        • Centro Cardiologico Monzino
      • Padua, Italy, 35128
        • Azienda Ospedaliera di Padova - MASTER
      • Roma, Italy, 00161
        • A.O.U. Policlinico Umberto I
      • Rome, Italy, 00168
        • Policlinico A. Gemelli IRCCS
    • Bs
      • Brescia, Bs, Italy, 25123
        • Spedali Civili Brescia
    • Fe
      • Cona (Ferrara), Fe, Italy, 44124
        • A.O.U. Ferrara, Sant'Anna
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Japan
      • Himeji-shi, Hyogo, Japan, 670-8560
        • Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
      • Kitakyushu-shi,Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital_Cardiology
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital_Cardiovascular Medicine
      • Omihachiman-shi, Siga, Japan, 523-0082
        • Omihachiman Community Medical Center_Omihachiman-shi, Siga
      • Osaka, Japan, 534-0021
        • Osaka City General Hospital_Endocrinology and Diabetes Mellitus
      • Osaka-shi, Osaka, Japan, 530-8480
        • Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
      • Sapporo-shi, Hokkaido, Japan, 062-0003
        • Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine
      • Tokyo, Japan, 140-8522
        • Tokyo Shinagawa Hospital_Cardiovascular Medicine
  • Netherlands
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen Apeldoorn
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate Ziekenhuis
      • Beverwijk, Netherlands, 1942 LE
        • Rode Kruis Ziekenhuis Beverwijk
      • Groningen, Netherlands, 9713 GZ
        • UMC Groningen
      • Hardenberg, Netherlands, 7772 SE
        • Saxenburgh Medisch Centrum
      • Leeuwarden, Netherlands, 8934 AD
        • Frisius MC Leeuwarden
      • Roosendaal, Netherlands, 4708 AE
        • Bravis ziekenhuis
  • Poland
      • Warsaw, Poland, 02-097
        • I Katedra i Klinika Kardiologii WUM SPCSK
    • Lesser Poland Voivodeship
      • Chrzanów, Lesser Poland Voivodeship, Poland, 32-500
        • Malopolskie Centrum Sercowo-Naczyniowe
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
      • Bialystok, Podlaskie Voivodeship, Poland, 15-540
        • Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-157
        • Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-648
        • Pro Familia Altera Sp. z o.o.
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-549
        • Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi
  • Spain
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Seville, Spain, 41003
        • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • Sweden
      • Gothenburg, Sweden, 416 50
        • Dept of Med Sahlgrenska/Östra
      • Jönköping, Sweden, 551 85
        • Medicinkliniken Ryhov
      • Uppsala, Sweden, 751 85
        • Hjärtmottagningen
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary
      • Glasgow, United Kingdom, G31 2ER
        • Glasgow Clinical Research Facility
      • High Wycombe, United Kingdom, HP11 2TT
        • Wycombe General Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital
      • Liverpool, United Kingdom, L9 7AL
        • University Hospital Aintree
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary_Manchester_0
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Eastern Shore Rsrch Inst, LLC
      • Mobile, Alabama, United States, 36608
        • Mobile Heart Specialists
    • California
      • Beverly Hills, California, United States, 90211
        • National Heart Institute Cal
      • Concord, California, United States, 94520
        • John Muir Physicians Network
      • Covina, California, United States, 91723
        • Valley Clinical Trials
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC - Outpatient Clinic
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Torrance, California, United States, 90502
        • Lundquist Inst-Biomed Innovtn
    • Colorado
      • Golden, Colorado, United States, 80401
        • New West Physicians,Inc.
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Med Ctr Clinical Trials
      • Brandon, Florida, United States, 33511
        • Bay Area Cardiology Associates, P.A.
      • Jacksonville, Florida, United States, 32258
        • Baptist Heart Specialists_Jacksonville
      • Miami, Florida, United States, 33173
        • CV Res Ctr of S Florida
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Endeavor Health Clinical Operations-NCH
      • Evanston, Illinois, United States, 60208
        • Northwestern University_Chicago_0
      • Evanston, Illinois, United States, 60201
        • Endeavor Health Glenbook Hosp
      • Hazel Crest, Illinois, United States, 60429
        • Chicago Medical Research LLC
    • Indiana
      • Evansville, Indiana, United States, 47747
        • Deaconess Specialty Physicians
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent Medical Group
      • Munster, Indiana, United States, 46321
        • Cardiovascular Rsrch of NW_IN
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Heart Center
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Baptist Health Woodland
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research, LLC
      • Hammond, Louisiana, United States, 70403
        • Heart Clinic of Hammond
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of Ame, LLC
      • Shreveport, Louisiana, United States, 71105
        • Grace Research, LLC_Shreveport
      • Slidell, Louisiana, United States, 70458
        • Louisiana Heart Center_Slidell
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Hospital
      • Baltimore, Maryland, United States, 21229
        • Ascension Saint Agnes Heart Ca
      • Baltimore, Maryland, United States, 21239
        • MedStar Good Samaritan Hosp
    • Michigan
      • Flint, Michigan, United States, 48532
        • Elite Research Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Univ of Mississippi Med Ctr
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, United States, 63136
        • St Louis Heart & Vascular, P.C.
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Heart
      • Omaha, Nebraska, United States, 68124
        • CHI Health Clinic Cardiology (CUMC - Bergan Mercy)
    • New York
      • Greenvale, New York, United States, 11548
        • St Francis Hospital Lindner Research Center
      • New York, New York, United States, 10021
        • NY Presbyt Hosp-W Cornell Med
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Lindner Center,Christ Hospital
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of University of Pennsylvania
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Health_Sioux Falls
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77025
        • Angio Cardiac Care of Texas
    • Virginia
      • Danville, Virginia, United States, 24541
        • Cardiology Consultants of Danville Inc.
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23298-5058
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide 2.4 mg once weekly (OW)
Participants will receive semaglutide injections for 52 weeks.
Drug: Semaglutide
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.
Placebo Comparator: Semaglutide placebo OW
Participants will receive semaglutide placebo injections for 52 weeks.
Drug: Placebo (Semaglutide)
Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Time Frame: 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.
From baseline (week 0) to end of treatment (week 52)
Change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 52)
Percentage (%)
From baseline (week 0) to end of treatment (week 52)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-minute walking distance
Time Frame: From baseline (week 0) to end of treatment (week 52)
Measured in metres
From baseline (week 0) to end of treatment (week 52)
Hierarchical composite of time to all-cause death
Time Frame: From baseline (week 0) to end of study (week 57)
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
Time Frame: From baseline (week 0) to end of study (week 57)
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
Time Frame: From baseline (week 0) to end of study (week 57)
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
Time Frame: From baseline (week 0) to end of study (week 57)
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
Time Frame: From baseline (week 0) to end of study (week 57)
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
Time Frame: From baseline (week 0) to end of study (week 57)
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)
Time Frame: From baseline (week 0) to end of study (week 57)
Measured as total wins for each treatment group.
From baseline (week 0) to end of study (week 57)
Change in C-Reactive Protein
Time Frame: From baseline (week -2) to end of treatment (week 52)
Presented as ratio to baseline
From baseline (week -2) to end of treatment (week 52)
Participant achieving 10% weight loss or more (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Count of participants
From baseline (week 0) to end of treatment (week 52)
Participant achieving 15% weight loss or more (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Count of participants
From baseline (week 0) to end of treatment (week 52)
Participant achieving 20% weight loss or more (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Count of participants
From baseline (week 0) to end of treatment (week 52)
Participant improving 5 points or more in KCCQ clinical summary score
Time Frame: From baseline (week 0) to end of treatment (week 52)
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)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Count of participants
From baseline (week 0) to end of treatment (week 52)
Change in KCCQ overall summary score
Time Frame: 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.
From baseline (week 0) to end of treatment (week 52)
Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS
Time Frame: From baseline (week 0) to end of treatment (week 52)
Count of participants
From baseline (week 0) to end of treatment (week 52)
Participant achieving threshold for clinically meaningful within-subject change in 6MWD
Time Frame: From baseline (week 0) to end of treatment (week 52)
Count of participants
From baseline (week 0) to end of treatment (week 52)
Change in waist circumference
Time Frame: From baseline (week 0) to end of treatment (visit 52)
Measured in centimetre (cm)
From baseline (week 0) to end of treatment (visit 52)
Change in systolic blood pressure
Time Frame: From baseline (week -2) to end of treatment (week 52)
Measured in millimetre of mercury (mmHg)
From baseline (week -2) to end of treatment (week 52)
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Measured in percentage (%)-point
From baseline (week 0) to end of treatment (week 52)
Number of treatment emergent severe or clinically significant hypoglycaemia episodes
Time Frame: From baseline (week 0) to end of trial (week 57)
Count of events
From baseline (week 0) to end of trial (week 57)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (Dept.1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX9536-4773
  • U1111-1257-5069 (Other Identifier: World Health Organization (WHO))
  • 2020-004170-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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