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Study · Randomized controlled trial · n = 616 · 2025

10 results

Semaglutide 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, van der Meer P, Verma S, Patel S, Chinnakondepalli KM, Borlaug BA, Butler J, Kitzman DW, Shah SJ, Harring S, Salsali A, Rasmussen S and 4 more

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von Lewinski D, Abhayaratna W, Petrie MC, Kosiborod MN

The lancet. Diabetes & endocrinology20 Jan 2025Cited by 20 (Europe PMC)

PMID39848268 (opens in a new tab)DOI10.1016/s2213-8587(24)00304-8 (opens in a new tab)PepBankPUB-39848268
Publisher pagePubMedAsk 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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    The effect of semaglutide on KCCQ-CSS did not differ significantly across baseline HbA1c categories (interaction and trend tests).

    In plain wordsThe heart failure symptom benefit of semaglutide was similar across baseline HbA1c levels.

    Peptide
    Semaglutide
    Outcome
    No significant changeKCCQ-CSS effect across baseline HbA1c categories
    Study

    n = 616

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    (pinteraction=0·64; ptrend=0·46)
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  2. 02HumanRandomized controlled trialEfficacy outcome

    The effect of semaglutide on bodyweight did not differ significantly across baseline HbA1c categories (interaction and trend tests).

    In plain wordsThe weight loss benefit of semaglutide was similar across baseline HbA1c levels.

    Peptide
    Semaglutide
    Outcome
    No significant changeBodyweight effect across baseline HbA1c categories
    Study

    n = 616

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    (pinteraction=0·22; ptrend=0·083)
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related HFpEF and type 2 diabetes with low baseline HbA1c, semaglutide improved the KCCQ-CSS more than placebo at 52 weeks.

    In plain wordsIn adults with heart failure, obesity and diabetes with low HbA1c, semaglutide improved heart failure symptoms more than placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseKCCQ-CSS change at week 52, low baseline HbA1c
    Study

    n = 227

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean difference KCCQ-CSS
    6.7 points
    low baseline HbA1c

    Source sentences

    Summary
    The change in KCCQ-CSS from baseline to 52 weeks was 12·4 points (95% CI 8·8 to 16·0) with semaglutide versus 5·7 points (2·1 to 9·2) with placebo (mean difference 6·7 points [1·6 to 11·8]) in the low baseline HbA1c group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related HFpEF and type 2 diabetes with low baseline HbA1c, semaglutide reduced bodyweight more than placebo at 52 weeks.

    In plain wordsIn adults with heart failure, obesity and diabetes with low HbA1c, semaglutide reduced body weight more than placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseBodyweight change at week 52, low baseline HbA1c
    Study

    n = 227

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean difference bodyweight
    −7.5%
    low baseline HbA1c

    Source sentences

    Summary
    The change in bodyweight percentage from baseline to 52 weeks was -10·8 (95% CI -12·1 to -9·5) with semaglutide versus -3·3% (-4·6 to -2·0) with placebo (mean difference -7·5% [-9·4 to -5·6]) in the low baseline HbA1c group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related HFpEF and type 2 diabetes with medium baseline HbA1c, semaglutide improved the KCCQ-CSS more than placebo at 52 weeks.

    In plain wordsIn adults with heart failure, obesity and diabetes with medium HbA1c, semaglutide improved heart failure symptoms more than placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseKCCQ-CSS change at week 52, medium baseline HbA1c
    Study

    n = 226

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean difference KCCQ-CSS
    6 points
    medium baseline HbA1c

    Source sentences

    Summary
    14·5 points (11·0 to 17·9) versus 8·5 points (4·8 to 12·2; 6·0 points [0·9 to 11·1]) in the medium baseline HbA1c group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related HFpEF and type 2 diabetes with medium baseline HbA1c, semaglutide reduced bodyweight more than placebo at 52 weeks.

    In plain wordsIn adults with heart failure, obesity and diabetes with medium HbA1c, semaglutide reduced body weight more than placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseBodyweight change at week 52, medium baseline HbA1c
    Study

    n = 226

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean difference bodyweight
    −6.3%
    medium baseline HbA1c

    Source sentences

    Summary
    -9·6% (-10·8 to -8·3) versus -3·3% (-4·7 to -1·9; -6·3 [-8·2 to -4·4]) in the medium baseline HbA1c group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related HFpEF and type 2 diabetes with high baseline HbA1c, semaglutide improved the KCCQ-CSS more than placebo at 52 weeks.

    In plain wordsIn adults with heart failure, obesity and diabetes with high HbA1c, semaglutide improved heart failure symptoms more than placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseKCCQ-CSS change at week 52, high baseline HbA1c
    Study

    n = 163

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean difference KCCQ-CSS
    9.6 points
    high baseline HbA1c

    Source sentences

    Summary
    14·5 points (10·0 to 19·0) versus 4·8 points (0·7 to 8·9; 9·6 points [3·5 to 15·7]) in the high baseline HbA1c group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related HFpEF and type 2 diabetes with high baseline HbA1c, semaglutide reduced bodyweight more than placebo at 52 weeks.

    In plain wordsIn adults with heart failure, obesity and diabetes with high HbA1c, semaglutide reduced body weight more than placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseBodyweight change at week 52, high baseline HbA1c
    Study

    n = 163

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean difference bodyweight
    −5%
    high baseline HbA1c

    Source sentences

    Summary
    -8·6% (-10·2 to -7·0) versus -3·6% (-5·2 to -2·1; -5·0 [-7·2 to -2·7]) in the high baseline HbA1c group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  9. 09HumanRandomized controlled trialSafety outcome

    In adults with obesity-related HFpEF and type 2 diabetes, hypoglycaemia occurred in 10% of semaglutide participants and 7% of placebo participants.

    In plain wordsIn adults with heart failure, obesity and diabetes, 10% on semaglutide and 7% on placebo had low blood sugar events.

    Peptide
    Semaglutide
    Outcome
    IncreaseParticipants with hypoglycaemia events
    Study

    n = 616

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with hypoglycaemia
    10%
    semaglutide
    Participants with hypoglycaemia
    7%
    placebo

    Source sentences

    Summary
    Hypoglycaemia events occurred in 30 (10%) of 310 participants (70 events; 22·9 events per 100 person-years) in the semaglutide group compared with 21 (7%) of 306 participants in the placebo group
    2 context sentences
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).
  10. 10HumanRandomized controlled trialSafety outcome

    The hypoglycaemia event rate was lower with semaglutide (22.9 per 100 person-years) than with placebo (29.5 per 100 person-years).

    In plain wordsLow blood sugar events per person-year were fewer with semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseHypoglycaemia event rate
    Study

    n = 616

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    2.4 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia event rate
    22.9 events per 100 person-years
    semaglutide
    Hypoglycaemia event rate
    29.5 events per 100 person-years
    placebo

    Source sentences

    Summary
    Hypoglycaemia events occurred in 30 (10%) of 310 participants (70 events; 22·9 events per 100 person-years) in the semaglutide group compared with 21 (7%) of 306 participants in the placebo group (90 events; 29·5 events per 100 person-years).
    3 context sentences
    Summary · context
    Semaglutide 2·4 mg improved heart failure-related symptoms and physical limitations, and reduced bodyweight in patients with obesity-related HFpEF and type 2 diabetes, all independently of baseline HbA1c, and resulted in lower rates of hypoglycaemia than placebo, despite a well controlled…
    Summary · context
    Participants were randomly assigned (1:1), with a block size of four within each stratum using an interactive web response system, stratified by baseline BMI (2vs ≥35 kg/m2), to receive either semaglutide 2·4 mg or placebo subcutaneously.
    Summary · context
    The effects of semaglutide versus placebo on the efficacy endpoints were evaluated by HbA1c categories at baseline: low (<6·5%; <48 mmol/mol), medium (6·5% to <7·5%; 48 mmol/mol to <58 mmol/mol), and high (≥7·5%; ≥58 mmol/mol).

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 pageClinicalTrials.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.

  1. Version 2Current

    11 Oct 2026, 00:04 UTC

    Study results updated

  2. 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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