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Study · Randomized controlled trial · n = 529 · 2023

6 results

Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity.

Kosiborod MN, Abildstrøm SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, Hovingh GK, Kitzman DW, Lindegaard ML, Møller DV, Shah SJ, Treppendahl MB and 19 more

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Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Núñez J, Perna E, Schou M, Senni M, Sharma K, Van der Meer P, von Lewinski D, Wolf D, Petrie MC

The New England journal of medicine25 Aug 2023Cited by 1,372 (Europe PMC)

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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with heart failure with preserved ejection fraction and obesity, semaglutide improved the KCCQ clinical summary score more than placebo.

    In plain wordsIn adults with obesity and heart failure, semaglutide improved symptom scores more than placebo.

    Outcome
    IncreaseKCCQ-CSS change
    Study

    n = 529

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

    Measurements

    KCCQ-CSS change
    16.6 points
    semaglutide
    KCCQ-CSS change
    8.7 points
    placebo
    estimated difference
    7.8 points
    semaglutide vs placebo

    Source sentences

    Summary
    The mean change in the KCCQ-CSS was 16.6 points with semaglutide and 8.7 points with placebo (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; P<0.001)
    1 context sentence
    Summary · context
    We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with heart failure with preserved ejection fraction and obesity, semaglutide reduced body weight more than placebo.

    In plain wordsIn adults with obesity and heart failure, semaglutide led to more weight loss than placebo.

    Outcome
    DecreaseBody weight percentage change
    Study

    n = 529

    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 change
    −13.3%
    semaglutide
    body weight change
    −2.6%
    placebo
    estimated difference
    −10.7 percentage points
    semaglutide vs placebo

    Source sentences

    Summary
    and the mean percentage change in body weight was -13.3% with semaglutide and -2.6% with placebo (estimated difference, -10.7 percentage points; 95% CI, -11.9 to -9.4; P<0.001).
    1 context sentence
    Summary · context
    We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with heart failure with preserved ejection fraction and obesity, semaglutide increased 6-minute walk distance more than placebo.

    In plain wordsIn adults with obesity and heart failure, semaglutide increased walking distance more than placebo.

    Outcome
    Increase6-minute walk distance change
    Study

    n = 529

    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).

    Measurements

    6-minute walk distance change
    21.5 m
    semaglutide
    6-minute walk distance change
    1.2 m
    placebo
    estimated difference
    20.3 m
    semaglutide vs placebo

    Source sentences

    Summary
    The mean change in the 6-minute walk distance was 21.5 m with semaglutide and 1.2 m with placebo (estimated difference, 20.3 m; 95% CI, 8.6 to 32.1; P<0.001).
    1 context sentence
    Summary · context
    We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with heart failure with preserved ejection fraction and obesity, semaglutide produced more wins than placebo in the hierarchical composite end point.

    In plain wordsIn adults with obesity and heart failure, a combined measure of outcomes favored semaglutide over placebo.

    Outcome
    IncreaseHierarchical composite end point
    Study

    n = 529

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    2.4 mg once weekly · 52 weeksAs given in this study (human).

    Measurements

    win ratio
    1.72 ratio
    semaglutide vs placebo

    Source sentences

    Summary
    In the analysis of the hierarchical composite end point, semaglutide produced more wins than placebo (win ratio, 1.72; 95% CI, 1.37 to 2.15; P<0.001).
    1 context sentence
    Summary · context
    We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with heart failure with preserved ejection fraction and obesity, semaglutide lowered C-reactive protein more than placebo.

    In plain wordsIn adults with obesity and heart failure, semaglutide lowered an inflammation marker more than placebo.

    Outcome
    DecreaseC-reactive protein percentage change
    Study

    n = 529

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    2.4 mg once weekly · 52 weeksAs given in this study (human).

    Measurements

    CRP change
    −43.5%
    semaglutide
    CRP change
    −7.3%
    placebo
    estimated treatment ratio
    0.61 ratio
    semaglutide vs placebo

    Source sentences

    Summary
    The mean percentage change in the CRP level was -43.5% with semaglutide and -7.3% with placebo (estimated treatment ratio, 0.61; 95% CI, 0.51 to 0.72; P<0.001).
    1 context sentence
    Summary · context
    We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with heart failure with preserved ejection fraction and obesity, fewer participants had serious adverse events with semaglutide than with placebo.

    In plain wordsIn adults with obesity and heart failure, fewer people had serious adverse events with semaglutide than with placebo.

    Outcome
    DecreaseSerious adverse events
    Study

    n = 529

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2.4 mg once weekly · 52 weeksAs given in this study (human).

    Measurements

    participants with serious adverse events
    35 participants
    semaglutide
    participants with serious adverse events
    71 participants
    placebo

    Source sentences

    Summary
    Serious adverse events were reported in 35 participants (13.3%) in the semaglutide group and 71 (26.7%) in the placebo group.
    1 context sentence
    Summary · context
    We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.

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

Registered trials2

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

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

Not yet recruitingPhase 3NCT07738276

Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity

Shahid Beheshti University of Medical Sciencesn = 60est. 18 Jul 2026 to est. 22 Dec 2027

Heart Failure and Reduced Ejection Fraction · Obesity & Overweight · Tirzepatide

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

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

    9 Oct 2026, 18:17 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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