Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF)

November 30, 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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
529

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • San Carlos de Bolívar, Buenos Aires, Argentina, 1334
        • Master Centre for Argentina
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital_Garran
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital - Cardiology Department
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Geelong Cardiology Research Unit
  • Canada
      • Québec, Canada, G1V 4G5
        • Unv de Cardiologie et dePneum
    • 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)
      • North York, Ontario, Canada, M6B 3H7
        • North York Diagn & Cardiac Ctr
      • Oakville, Ontario, Canada, L6K 3W7
        • Oakville Cardiovascular Research LP
      • Oshawa, Ontario, Canada, L1J 2K1
        • Dr James Cha
      • Scarborough Village, Ontario, Canada, M1B 4Z8
        • Heart Health Institute Research, Inc.
      • Weston, Ontario, Canada, M9N 1W4
        • Dr. Louis Yao
    • Quebec
      • Montreal, Quebec, Canada, H1T 3Y7
        • Clinique Sante Cardio MC
  • Czechia
      • Jihlava, Czechia, 586 33
        • Nemocnice Jihlava
      • Jihlava, Czechia, 586 33
        • Nemocnice Jihlava Kardiologie
      • Prague, Czechia, 128 00
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 140 21
        • IKEM
      • Prague, Czechia, 170 00
        • Medicon a.s.
      • Prague, Czechia, 170 00
        • Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.
      • Prague, Czechia, 128 00
        • Vseobecna fakultni nemocnice a 1 LF UK v Praze
      • Slaný, Czechia, 274 01
        • Nemocnice Slany Kardiologie
      • Tábor, Czechia, 390 03
        • Nemocnice Tábor a.s.
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Hjertesygdomme
      • Svendborg, Denmark, 5700
        • Kardiologisk Odense & Svendborg
    • Capital Region
      • Hellerup, Capital Region, Denmark, 2900
        • Herlev og Gentofte Hospital
  • 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
        • Appel
      • Kassel, Germany, 34121
        • B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH
      • 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
      • 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
  • 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
  • Netherlands
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen Apeldoorn
      • 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, 15-540
        • 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
      • Madrid, Spain, 28023
        • Hospital Universitario La Zarzuela
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Barnet Hospital - Cardiology Department
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • 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, M23 9LT
        • Wythenshawe Hospital_North West Heart Centre
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Taunton, United Kingdom, TA1 5DA
        • Musgrove Park Hospital
      • Tooting, United Kingdom, SW17 0QT
        • St George's Hospital
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Yeovil District Hospital - Clinical Research Unit
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6SE
        • St. Richards Hospital_Cardiology
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Eastern Shore Rsrch Inst, LLC
    • California
      • Beverly Hills, California, United States, 90211
        • National Heart Institute Cal
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC - Outpatient Clinic
      • Torrance, California, United States, 90502
        • Lundquist Inst-Biomed Innovtn
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Ctr For Clin Res
      • Jacksonville, Florida, United States, 32258
        • Baptist Heart Specialists_Jacksonville
      • Jacksonville, Florida, United States, 32257
        • First Coast Cardiovascular Institute
      • Miami, Florida, United States, 33173
        • CV Res Ctr of S Florida
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Endeavor Health Clinical Operations-NCH
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine
      • 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
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent Medical Group
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center_Kansas City
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
      • Madisonville, Kentucky, United States, 42431
        • Baptist Health Madisonville, Inc
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research, LLC
      • Hammond, Louisiana, United States, 70403
        • Heart Clinic of Hammond
      • Shreveport, Louisiana, United States, 71105
        • Grace Research, LLC_Shreveport
      • Slidell, Louisiana, United States, 70458
        • LOUISIANA HEART Center
      • 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
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester
    • 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
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine
    • 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 the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Univ of South Carolina_Charleston_0
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Health_Sioux Falls
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine
    • Virginia
      • Danville, Virginia, United States, 24541
        • Cardiology Consultants of Danville Inc.
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart
      • Norfolk, Virginia, United States, 23507
        • Sentara Health Research Center
      • Richmond, Virginia, United States, 23298-5058
        • Virginia Commonwealth University Health System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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 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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Semaglutide
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
Drug: Semaglutide

Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.

Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.
Placebo Comparator: Placebo (semaglutide)
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
Drug: Placebo (semaglutide)

Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.

The study will last for approximately 59 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time Frame: From baseline (week 0) to end of treatment (week 52)
The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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)
Change in body weight from baseline (week 0) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Six-minute Walking Distance (6MWD)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Observed mean change from baseline (week 0) in 6 minutes walking distance (6MWD) test to end of treatment (week 52) is presented. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs
Time Frame: From baseline (week 0) to end of study (week 57)
The hierarchical composite outcome measure from baseline (week 0) to end of study (week 57) consists of the components: time to all-cause death, number of heart failure events requiring hospitalization or urgent heart failure visit, time to first heart failure event requiring hospitalization or urgent heart failure visit, difference at least 15 in KCCQ CSS change from baseline to 52 weeks, difference at least 10 in KCCQ CSS change from baseline to 52 weeks, difference at least 5 in KCCQ CSS change from baseline to 52 weeks and difference at least 30 meters in six-minute walking distance change from baseline to 52 weeks. It was analyzed by the win-ratio approach using all participants pairs across treatment groups. Overall summary of wins in each treatment group is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of study (week 57)
Change in C-Reactive Protein (CRP): Ratio to Baseline
Time Frame: From baseline (week -2) to end of treatment (week 52)
Change in high sensitivity C-reactive protein measured in ratio of C-reactive protein to baseline (week -2) at end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week -2) to end of treatment (week 52)
Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Percentage of participants who achieved 10% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 10% weight loss whereas 'No' infers percentage of participants who have not achieved 10% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
Percentage of Participants Achieving 15% Weight Loss (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Percentage of participants who achieved 15% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 15% weight loss whereas 'No' infers percentage of participants who have not achieved 15% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
Percentage of Participants Achieving 20% Weight Loss (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Percentage of participants who achieved 20% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 20% weight loss whereas 'No' infers percentage of participants who have not achieved 20% weight loss The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Percentage of participants improving 5 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In the reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 5 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Percentage of participants improving 10 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 10 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
Change in KCCQ Overall Summary Score (KCCQ-OSS)
Time Frame: From baseline (week 0) to end of treatment (week 52)
The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ while KCCQ-OSS includes the symptom, physical limitation, quality of life, and social limitation domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (week 52)
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S)
Time Frame: From baseline (week 0) to end of treatment (week 52)
The patient global impression of status (PGI-S) for KCCQ was used to rate participants' symptoms of heart failure using 4-category ordinal scale (no symptoms, mild, moderate, severe). KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. OSS and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. Outcome measure was evaluated based on data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site. The threshold was defined as mean change in KCCQ-CSS in those participants with one-category improvement in PGI-S from baseline to week 52.
From baseline (week 0) to end of treatment (week 52)
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S)
Time Frame: From baseline (week 0) to end of treatment (week 52)
Observed mean change from baseline in 6 minutes walking distance (6MWD) test using PGI-S is evaluated for this outcome measure. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. The threshold was defined as the mean change in 6MWD in those participants with an one-category improvement in PGI-S from baseline to week 52.
From baseline (week 0) to end of treatment (week 52)
Change in Systolic Blood Pressure (SBP)
Time Frame: From baseline (week -2) to end of treatment (week 52)
Observed mean change in systolic blood pressure from baseline (week -2) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week -2) to end of treatment (week 52)
Change in Waist Circumference
Time Frame: From baseline (week 0) to end of treatment (visit 52)
Change waist circumference from baseline (week 0) to end of the treatment (visit 52) presented. Waist circumference is defined as the abdominal circumference located midway between the lower rib margin and the iliac crest. Measurement must be obtained in standing position with a non-stretchable measuring tape and to the nearest cm or inch. The tape should touch the skin but not compress soft tissue and twists in the tape should be avoided. The participant should be asked to breathe normally. The same measuring tape should be used throughout the trial. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
From baseline (week 0) to end of treatment (visit 52)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX9536-4665
  • U1111-1243-4358 (Other Identifier: World Health Organization (WHO))
  • 2019-004452-11 (Registry Identifier: European Medicines Agency (EudraCT))

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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