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Study · Randomized controlled trial · n = 616 · 2024

6 results

Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.

Kosiborod MN, Petrie MC, Borlaug BA, Butler J, Davies MJ, Hovingh GK, Kitzman DW, Møller DV, Treppendahl MB, Verma S, Jensen TJ, Liisberg K and 20 more

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Lindegaard ML, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Melenovský V, Merkely B, Núñez J, Perna E, Schou M, Senni M, Sharma K, van der Meer P, Von Lewinski D, Wolf D, Shah SJ

The New England journal of medicine6 Apr 2024Cited by 622 (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 obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide improved the KCCQ clinical summary score more than placebo.

    In plain wordsIn adults with obesity, type 2 diabetes and heart failure, semaglutide improved symptom scores more than placebo.

    Outcome
    IncreaseKCCQ-CSS change at 52 weeks
    Study

    n = 616

    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
    13.7 points
    semaglutide
    KCCQ-CSS change
    6.4 points
    placebo
    estimated difference
    7.3 points
    semaglutide vs placebo

    Source sentences

    Summary
    The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001)
    1 context sentence
    Summary · context
    We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide reduced body weight more than placebo.

    In plain wordsIn adults with obesity, type 2 diabetes and heart failure, semaglutide led to more weight loss than placebo.

    Outcome
    DecreaseBody weight percentage change
    Study

    n = 616

    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
    −9.8%
    semaglutide
    body weight change
    −3.4%
    placebo
    estimated difference
    −6.4 percentage points
    semaglutide vs placebo

    Source sentences

    Summary
    and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001).
    1 context sentence
    Summary · context
    We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide increased 6-minute walk distance more than placebo.

    In plain wordsIn adults with obesity, type 2 diabetes and heart failure, semaglutide increased walking distance more than placebo.

    Outcome
    Increase6-minute walk distance change
    Study

    n = 616

    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 difference
    14.3 m
    semaglutide vs placebo

    Source sentences

    Summary
    estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]
    1 context sentence
    Summary · context
    We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, the hierarchical composite end point favored semaglutide over placebo.

    In plain wordsIn adults with obesity, type 2 diabetes and heart failure, a combined measure of outcomes favored semaglutide over placebo.

    Outcome
    IncreaseHierarchical composite end point
    Study

    n = 616

    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
    1.58 ratio
    semaglutide vs placebo

    Source sentences

    Summary
    win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]
    1 context sentence
    Summary · context
    We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide lowered C-reactive protein more than placebo.

    In plain wordsIn adults with obesity, type 2 diabetes and heart failure, semaglutide lowered an inflammation marker more than placebo.

    Outcome
    DecreaseC-reactive protein change
    Study

    n = 616

    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 treatment ratio
    0.67 ratio
    semaglutide vs placebo

    Source sentences

    Summary
    estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]).
    1 context sentence
    Summary · context
    We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, fewer participants had serious adverse events with semaglutide than with placebo.

    In plain wordsIn adults with obesity, type 2 diabetes and heart failure, fewer people had serious adverse events with semaglutide than with placebo.

    Outcome
    DecreaseSerious adverse events
    Study

    n = 616

    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
    55 participants
    semaglutide
    participants with serious adverse events
    88 participants
    placebo

    Source sentences

    Summary
    Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group.
    1 context sentence
    Summary · context
    We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes 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 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

    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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