LivingGLP1
Study S000161

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

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT04916470
Acronym
STEP HFpEF DM
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
617
Start
2021-06-15
Primary completion
2023-10-11
Lead sponsor
Novo Nordisk A/S
Conditions
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
Interventions
DRUG:Semaglutide; DRUG:Placebo (Semaglutide)
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1257-5069; EUDRACT_NUMBER:2020-004170-22

Registered primary outcomes

  • Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score [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 (14)

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:NCT04916470; registry reference DERIVED:40956259
R0015844Semaglutide and Exercise Function in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.
Borlaug BA, JACC. Heart failure
2025Randomized trialPMID 41045908DOIcites ClinicalTrials.gov:NCT04916470; registry reference DERIVED:41045908
R0018972Semaglutide 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.
Davies MJ, The lancet. Diabetes & endocrinology
2025Randomized trialPMID 39848268DOIcites ClinicalTrials.gov:NCT04916470; registry reference DERIVED:39848268
R0042191Semaglutide 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
Melanie Davies (20342379), Figshare
2025Randomized trialcites ClinicalTrials.gov:NCT04916470
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:NCT04916470; 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:NCT04916470; registry reference DERIVED:39217567
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:NCT04916470; 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:NCT04916470; registry reference DERIVED:38913004
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:NCT04916470; registry reference DERIVED:39217565
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:NCT04916470; registry reference DERIVED:38913003
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:NCT04916470; 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:NCT04916470; registry reference DERIVED:39217564
R0020223Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.
Kosiborod MN, The New England journal of medicine
2024Randomized trialPMID 38587233DOIcites ClinicalTrials.gov:NCT04916470; registry reference DERIVED:38587233
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:NCT04916470; registry reference BACKGROUND:37294245