Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction: The STEP-HFpEF Program.

Schou M, Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Verma S, Patel S, Chinnakondepalli KM, Harring S, Abildstrøm SZ, Liisberg K, Kosiborod MN

Journal of the American College of Cardiology23 Jun 2024Cited by 45 (Europe PMC)

PMID38913004DOI10.1016/j.jacc.2024.04.038PepBankPUB-38913004

Publisher page PubMedAsk about this study

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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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, more semaglutide-treated than placebo-treated patients had an improvement in NYHA functional class at 52 weeks.
In plain wordsIn adults with obesity and heart failure, more people on semaglutide than on placebo moved to a better heart failure class after 52 weeks.
Peptide
Semaglutide
Outcome
IncreaseImprovement in NYHA functional class
Study
n = 1,145
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Measurements
Patients with NYHA improvement
32.6%
semaglutide
Patients with NYHA improvement
21.5%
placebo
OR
2.2 ratio
semaglutide vs placebo
Source sentences
Summary
More semaglutide-treated than placebo-treated patients had an improvement in NYHA functional class (32.6% vs 21.5%, respectively; OR: 2.20 [95% CI: 1.62-2.99; P < 0.001]) and fewer semaglutide-treated patients experienced deterioration in NYHA functional class (2.09% vs 5.24%, respectively; OR: 0.36…
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300401
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, fewer semaglutide-treated than placebo-treated patients had deterioration in NYHA functional class at 52 weeks.
In plain wordsIn adults with obesity and heart failure, fewer people on semaglutide than on placebo moved to a worse heart failure class after 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseDeterioration in NYHA functional class
Study
n = 1,145
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Measurements
Patients with NYHA deterioration
2.09%
semaglutide
Patients with NYHA deterioration
5.24%
placebo
OR
0.36 ratio
semaglutide vs placebo
Source sentences
Summary
and fewer semaglutide-treated patients experienced deterioration in NYHA functional class (2.09% vs 5.24%, respectively; OR: 0.36 [95% CI: 0.19-0.70; P = 0.003]) at 52 weeks.
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300402
03HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide consistently improved 6-minute walking distance across NYHA classes.
In plain wordsIn adults with obesity and heart failure, semaglutide improved walking distance across all heart failure classes, compared with placebo.
Peptide
Semaglutide
Outcome
Increase6-minute walking distance across NYHA classes
Study
n = 1,145
Comparator
Placebo
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 consistently improved 6-minute walking distance (6MWD), the hierarchical composite endpoint (death, HF events, differences in KCCQ-CSS, and 6MWD changes), and reduced C-reactive protein and N-terminal prohormone of brain natriuretic peptide across NYHA functional class categories (all P interactions = NS).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300405
04HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide consistently improved the hierarchical composite endpoint across NYHA classes.
In plain wordsIn adults with obesity and heart failure, semaglutide improved a combined score of death, heart failure events, symptoms and walking across all classes.
Peptide
Semaglutide
Outcome
IncreaseHierarchical composite endpoint across NYHA classes
Study
n = 1,145
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Semaglutide consistently improved 6-minute walking distance (6MWD), the hierarchical composite endpoint (death, HF events, differences in KCCQ-CSS, and 6MWD changes), and reduced C-reactive protein and N-terminal prohormone of brain natriuretic peptide across NYHA functional class categories (all P interactions = NS).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300406
05HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide reduced C-reactive protein across NYHA classes.
In plain wordsIn adults with obesity and heart failure, semaglutide lowered the inflammation marker C-reactive protein across all heart failure classes, compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseC-reactive protein across NYHA classes
Study
n = 1,145
Comparator
Placebo
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Semaglutide consistently improved 6-minute walking distance (6MWD), the hierarchical composite endpoint (death, HF events, differences in KCCQ-CSS, and 6MWD changes), and reduced C-reactive protein and N-terminal prohormone of brain natriuretic peptide across NYHA functional class categories (all P interactions = NS).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300407
06HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide reduced N-terminal prohormone of brain natriuretic peptide across NYHA classes.
In plain wordsIn adults with obesity and heart failure, semaglutide lowered a blood marker of heart strain across all heart failure classes, compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseNT-proBNP across NYHA classes
Study
n = 1,145
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Source sentences
Summary
Semaglutide consistently improved 6-minute walking distance (6MWD), the hierarchical composite endpoint (death, HF events, differences in KCCQ-CSS, and 6MWD changes), and reduced C-reactive protein and N-terminal prohormone of brain natriuretic peptide across NYHA functional class categories (all P interactions = NS).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300408
07HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide improved KCCQ-CCS versus placebo across NYHA classes, with larger gains in classes III/IV than in class II.
In plain wordsIn adults with obesity and heart failure, semaglutide improved symptom scores more than placebo in every class, especially in the sickest patients.
Peptide
Semaglutide
Outcome
IncreaseKCCQ-CSS change by NYHA class
Study
n: not reported in source
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Measurements
KCCQ-CCS difference
10.5 points
NYHA III/IV
KCCQ-CCS difference
6 points
NYHA II
Source sentences
Summary
Semaglutide (vs placebo) improved the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CCS) across NYHA functional class categories; this was especially pronounced in those in NYHA functional classes III/IV (10.5 points [95% CI: 6.6-14.4 points]) vs NYHA functional class II (6.0…
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300403
08HumanRandomized controlled trialEfficacy outcome
In adults with obesity-related HFpEF, semaglutide reduced body weight to a similar degree versus placebo regardless of baseline NYHA class.
In plain wordsIn adults with obesity and heart failure, semaglutide lowered body weight about equally compared with placebo, whatever the starting heart failure class.
Peptide
Semaglutide
Outcome
DecreaseBody weight change by NYHA class
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · 52 weeksAs given in this study (human).
Measurements
Body weight change
−8.4%
NYHA II
Body weight change
−8.3%
NYHA III/IV
Source sentences
Summary
By contrast, the degree of reduction in bodyweight was similar with semaglutide vs placebo regardless of baseline NYHA functional class category (NYHA functional class II, -8.4% [95% CI: -9.4% to -7.3%]; NYHA functional classes III/IV, -8.3% [95% CI: -9.9% to -6.8%]; P interaction = 0.96).
1 context sentence(design, population, supporting numbers)
Summary · context
This was a prespecified analysis of pooled data from 2 international, double-blind, randomized trials (STEP-HFpEF and STEP-HFpEF type 2 diabetes [STEP-HFpEF DM], comprising the STEP-HFpEF program), which collectively randomized 1,145 participants with obesity-related HFpEF to once-weekly semaglutide…
Report a problemFND-3891300404

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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