Efficacy of Semaglutide by Sex in Obesity-Related Heart Failure With Preserved Ejection Fraction: STEP-HFpEF Trials.

Verma S, Butler J, Borlaug BA, Davies M, Kitzman DW, Shah SJ, Petrie MC, Barros E, Rönnbäck C, Vestergaard LS, Schou M, Ezekowitz JA and 4 more

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Sharma K, Patel S, Chinnakondepalli KM, Kosiborod MN

Journal of the American College of Cardiology23 Jun 2024Cited by 48 (Europe PMC)

PMID38913003DOI10.1016/j.jacc.2024.06.001PepBankPUB-38913003

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide improved the KCCQ-CSS score similarly in women and men.
In plain wordsIn adults with obesity and heart failure, semaglutide improved heart failure symptom scores about equally in women and men, compared with placebo.
Peptide
Semaglutide
Outcome
IncreaseKCCQ-CSS change by sex
Study
n = 1,145
Comparator
Placebo
Analysis
Primary
Outcome group
Heart function · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Measurements
KCCQ-CSS mean difference
7.6 points
women
KCCQ-CSS mean difference
7.5 points
men
Source sentences
Summary
Semaglutide improved KCCQ-CSS regardless of sex (mean difference in women +7.6 points [95% CI: 4.5-10.7 points]; men +7.5 points [95% CI: 4.3-10.6 points]; P interaction = 0.94)
1 context sentence(design, population, supporting numbers)
Summary · context
patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m², and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks.
Report a problemFND-3891300301
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide reduced body weight more in women than in men.
In plain wordsIn adults with obesity and heart failure, semaglutide lowered body weight more in women than in men, compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseBody weight change by sex
Study
n = 1,145
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Measurements
Body weight mean difference
−9.6%
women
Body weight mean difference
−7.2%
men
Source sentences
Summary
but reduced body weight more in women (mean difference in women -9.6% [95% CI: -10.9% to -8.4%]; men -7.2% [95% CI: -8.4% to -6.0%]; P interaction = 0.006).
1 context sentence(design, population, supporting numbers)
Summary · context
patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m², and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks.
Report a problemFND-3891300302
03HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide improved 6-minute walking distance in both sexes.
In plain wordsIn adults with obesity and heart failure, semaglutide improved walking distance in both women and men, compared with placebo.
Peptide
Semaglutide
Outcome
Increase6-minute walking distance by sex
Study
n = 1,145
Comparator
Placebo
Analysis
Secondary
Outcome group
Exercise and physical function · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Semaglutide improved 6MWD (P interaction = 0.21) and the hierarchical composite endpoint (P interaction = 0.66) in both sexes.
1 context sentence(design, population, supporting numbers)
Summary · context
patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m², and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks.
Report a problemFND-3891300303
04HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide improved the hierarchical composite endpoint in both sexes.
In plain wordsIn adults with obesity and heart failure, semaglutide improved a combined score of death, heart failure events, symptoms and walking in both sexes.
Peptide
Semaglutide
Outcome
IncreaseHierarchical composite endpoint by sex
Study
n = 1,145
Comparator
Placebo
Analysis
Secondary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Semaglutide improved 6MWD (P interaction = 0.21) and the hierarchical composite endpoint (P interaction = 0.66) in both sexes.
1 context sentence(design, population, supporting numbers)
Summary · context
patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m², and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks.
Report a problemFND-3891300304
05HumanRandomized controlled trialSafety outcome
In adults with obesity-related HFpEF, fewer serious adverse events were reported with semaglutide than with placebo.
In plain wordsIn adults with obesity and heart failure, fewer serious adverse events were reported with semaglutide than with placebo.
Peptide
Semaglutide
Outcome
DecreaseSerious adverse events
Study
n = 1,145
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Fewer serious adverse events were reported with semaglutide vs placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
patients with heart failure (HF), left ventricular ejection fraction ≥45%, body mass index ≥30 kg/m², and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) <90 points were randomized 1:1 to once-weekly semaglutide 2.4 mg or matched placebo for 52 weeks.
Report a problemFND-3891300305

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT04916470

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

Novo Nordisk A/Sn = 61715 Jun 2021 to 11 Oct 2023

Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 26 Nov 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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