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Study · Randomized controlled trial · n = 3,743 · 2024

4 results

Semaglutide 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, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC and 7 more

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Plutzky J, Rasmussen S, Rönnbäck C, Shah SJ, Verma S, Weeke PE, Lincoff AM

Lancet (London, England)30 Aug 2024Cited by 232 (Europe PMC)

PMID39222642 (opens in a new tab)DOI10.1016/s0140-6736(24)01643-x (opens in a new tab)PepBankPUB-39222642
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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In participants with a history of HFpEF, semaglutide reduced the risk of cardiovascular death or heart failure events versus placebo (hazard ratio 0.69).

    In plain wordsIn people with heart failure with preserved ejection fraction, semaglutide lowered the risk of heart failure events or cardiovascular death compared with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseCardiovascular death or first worsening heart failure event
    Study

    n = 3,743

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    2.4 mg once weekly (SELECT, STEP-HFpEF, STEP-HFpEF DM); 1.0 mg once weekly (FLOW) · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    In this group of participants with HFpEF, semaglutide reduced the risk of the combined endpoint of cardiovascular death or heart failure events (103 [5·4%] of 1914 in the semaglutide group had events vs 138 [7·5%] of 1829 in the placebo group; hazard ratio [HR] 0·69 [95% CI 0·53-0·89]; p=0·0045).
    2 context sentences
    Summary · context
    We conducted a post-hoc pooled, participant-level analysis of four randomised, placebo-controlled trials (SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM) to examine the effects of once-weekly subcutaneous semaglutide (2·4 mg in SELECT, STEP-HFpEF, and STEP-HFpEF DM; 1·0 mg in FLOW) on heart failure events.
    Summary · context
    Across the four trials, 3743 (16·8%) of 22 282 participants had a history of HFpEF (1914 assigned to semaglutide and 1829 assigned to placebo).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In participants with a history of HFpEF, semaglutide reduced the risk of worsening heart failure events versus placebo (hazard ratio 0.59).

    In plain wordsIn people with heart failure with preserved ejection fraction, semaglutide lowered the risk of worsening heart failure compared with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseWorsening heart failure events
    Study

    n = 3,743

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    2.4 mg once weekly (SELECT, STEP-HFpEF, STEP-HFpEF DM); 1.0 mg once weekly (FLOW) · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Semaglutide also reduced the risk of worsening heart failure events (54 [2·8%] vs 86 [4·7%]; HR 0·59 [0·41-0·82]; p=0·0019).
    2 context sentences
    Summary · context
    We conducted a post-hoc pooled, participant-level analysis of four randomised, placebo-controlled trials (SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM) to examine the effects of once-weekly subcutaneous semaglutide (2·4 mg in SELECT, STEP-HFpEF, and STEP-HFpEF DM; 1·0 mg in FLOW) on heart failure events.
    Summary · context
    Across the four trials, 3743 (16·8%) of 22 282 participants had a history of HFpEF (1914 assigned to semaglutide and 1829 assigned to placebo).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In participants with a history of HFpEF, semaglutide had no significant effect on cardiovascular death alone versus placebo (hazard ratio 0.82).

    In plain wordsIn people with heart failure with preserved ejection fraction, semaglutide did not change the risk of cardiovascular death alone compared with placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeCardiovascular death
    Study

    n = 3,743

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    2.4 mg once weekly (SELECT, STEP-HFpEF, STEP-HFpEF DM); 1.0 mg once weekly (FLOW) · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    No significant effect on cardiovascular death alone was seen (59 [3·1%] vs 67 [3·7%]; HR 0·82 [0·57-1·16]; p=0·25).
    2 context sentences
    Summary · context
    We conducted a post-hoc pooled, participant-level analysis of four randomised, placebo-controlled trials (SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM) to examine the effects of once-weekly subcutaneous semaglutide (2·4 mg in SELECT, STEP-HFpEF, and STEP-HFpEF DM; 1·0 mg in FLOW) on heart failure events.
    Summary · context
    Across the four trials, 3743 (16·8%) of 22 282 participants had a history of HFpEF (1914 assigned to semaglutide and 1829 assigned to placebo).
  4. 04HumanRandomized controlled trialSafety outcome

    In participants with a history of HFpEF, a lower proportion had serious adverse events with semaglutide than with placebo (29.9% vs 38.7%).

    In plain wordsIn people with heart failure with preserved ejection fraction, fewer had serious adverse events with semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseSerious adverse events
    Study

    n = 3,743

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2.4 mg once weekly (SELECT, STEP-HFpEF, STEP-HFpEF DM); 1.0 mg once weekly (FLOW) · subcutaneousAs given in this study (human).

    Measurements

    Serious adverse events
    29.9%
    semaglutide
    Serious adverse events
    38.7%
    placebo

    Source sentences

    Summary
    A lower proportion of patients treated with semaglutide had serious adverse events than did those who were treated with placebo (572 [29·9%] vs 708 [38·7%]).
    2 context sentences
    Summary · context
    We conducted a post-hoc pooled, participant-level analysis of four randomised, placebo-controlled trials (SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM) to examine the effects of once-weekly subcutaneous semaglutide (2·4 mg in SELECT, STEP-HFpEF, and STEP-HFpEF DM; 1·0 mg in FLOW) on heart failure events.
    Summary · context
    Across the four trials, 3743 (16·8%) of 22 282 participants had a history of HFpEF (1914 assigned to semaglutide and 1829 assigned to placebo).

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

Registered trials5

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

5 trials · 1 not yet recruiting · 4 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 3NCT07090343

Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Leiden University Medical Centern = 826est. 1 Apr 2026 to est. 1 Apr 2031

Aortic Stenosis · Heart Failure

Trial pageClinicalTrials.govUpdated 29 Jul 2025
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
CompletedPhase 3Results postedNCT04788511

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

Novo Nordisk A/Sn = 52916 Mar 2021 to 18 Apr 2023

Obesity

Trial pageClinicalTrials.govUpdated 5 Dec 2025
CompletedPhase 3Results postedNCT03819153

A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

Novo Nordisk A/Sn = 3,53317 Jun 2019 to 9 Jan 2024

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 20 Mar 2025
CompletedPhase 3Results postedNCT03574597

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

Novo Nordisk A/Sn = 17,60424 Oct 2018 to 29 Jun 2023

Overweight · Obesity

Trial pageClinicalTrials.govUpdated 30 Aug 2024

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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