LivingGLP1
Study S002012

Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT04788511
Acronym
STEP-HFpEF
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
529
Start
2021-03-16
Primary completion
2023-04-18
Lead sponsor
Novo Nordisk A/S
Conditions
Obesity
Interventions
DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1243-4358; REGISTRY:2019-004452-11; NIH:2019

Registered primary outcomes

  • Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [From baseline (week 0) to end of treatment (week 52)]
  • Change in Body Weight [From baseline (week 0) to end of treatment (week 52)]

Linked records (16)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0015625Frailty and Effects of Semaglutide in Obesity-Related HFpEF: Findings From the STEP-HFpEF Program.
Pandey A, JACC. Heart failure
2025Randomized trialPMID 40956259DOIcites ClinicalTrials.gov:NCT04788511
R0015844Semaglutide and Exercise Function in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.
Borlaug BA, JACC. Heart failure
2025Randomized trialPMID 41045908DOIcites ClinicalTrials.gov:NCT04788511
R0016793Semaglutide 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.
Butler J, Lancet (London, England)
2024Randomized trialPMID 38599221DOIcites ClinicalTrials.gov:NCT04788511; registry reference DERIVED:38599221
R0018369Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure.
Solomon SD, Journal of the American College of Cardiology
2024Randomized trialPMID 39217567DOIcites ClinicalTrials.gov:NCT04788511
R0018556Semaglutide and diuretic use in obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF-DM trials.
Shah SJ, European heart journal
2024Randomized trialPMID 38739118DOIcites ClinicalTrials.gov:NCT04788511; registry reference DERIVED:38739118
R0018703Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction: The STEP-HFpEF Program.
Schou M, Journal of the American College of Cardiology
2024Randomized trialPMID 38913004DOIcites ClinicalTrials.gov:NCT04788511
R0018948Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Program.
Verma S, Journal of the American College of Cardiology
2024Randomized trialPMID 39217565DOIcites ClinicalTrials.gov:NCT04788511
R0019167Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Trials.
Verma S, Journal of the American College of Cardiology
2024Randomized trialPMID 38913003DOIcites ClinicalTrials.gov:NCT04788511
R0019192Semaglutide 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.
Kosiborod MN, Lancet (London, England)
2024Randomized trialPMID 39222642DOIcites ClinicalTrials.gov:NCT04788511; registry reference DERIVED:39222642
R0019395Inflammation in Obesity-Related HFpEF: The STEP-HFpEF Program.
Verma S, Journal of the American College of Cardiology
2024Randomized trialPMID 39217564DOIcites ClinicalTrials.gov:NCT04788511
R0020409Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial.
Kosiborod MN, Circulation
2024Randomized trialPMID 37952180DOIcites ClinicalTrials.gov:NCT04788511; registry reference DERIVED:37952180
R0042678Tackling metabolic defects in HFpEF
Rongling Wang, European Heart Journal
2024Other trialPMID 38367012DOIcites ClinicalTrials.gov:NCT04788511
R0009684Design and Baseline Characteristics of STEP-HFpEF Program Evaluating Semaglutide in Patients With Obesity HFpEF Phenotype.
Kosiborod MN, JACC. Heart failure
2023ProtocolPMID 37294245DOIcites ClinicalTrials.gov:NCT04788511
R0020386Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection Fraction.
Butler J, Journal of the American College of Cardiology
2023Randomized trialPMID 37993201DOIcites ClinicalTrials.gov:NCT04788511; registry reference DERIVED:37993201
R0020464Semaglutide in HFpEF across obesity class and by body weight reduction: a prespecified analysis of the STEP-HFpEF trial.
Borlaug BA, Nature medicine
2023Other trialPMID 37635157DOIcites ClinicalTrials.gov:NCT04788511; registry reference BACKGROUND:37635157
R0020837Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity.
Kosiborod MN, The New England journal of medicine
2023Randomized trialPMID 37622681DOIcites ClinicalTrials.gov:NCT04788511; registry reference RESULT:37622681