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Study · Randomized controlled trial · n = 3,533 · 2025

7 results

Cardiovascular outcomes with semaglutide by severity of chronic kidney disease in type 2 diabetes: the FLOW trial.

Mahaffey KW, Tuttle KR, Arici M, Baeres FMM, Bakris G, Charytan DM, Cherney DZI, Chernin G, Correa-Rotter R, Gumprecht J, Idorn T, Pugliese G and 7 more

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Rasmussen IKB, Rasmussen S, Rossing P, Sokareva E, Mann JFE, Perkovic V, Pratley R

European heart journal1 Mar 2025Cited by 40 (Europe PMC)

PMID39211948 (opens in a new tab)PMCIDPMC11931213 (opens in a new tab)DOI10.1093/eurheartj/ehae613 (opens in a new tab)PepBankPUB-39211948
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Summary

Background and aimsIn the FLOW trial, semaglutide reduced the risks of kidney and cardiovascular (CV) outcomes and death in participants with type 2 diabetes and chronic kidney disease (CKD). These prespecified analyses assessed the effects of semaglutide on CV outcomes and death by CKD severity.MethodsParticipants were randomized to subcutaneous semaglutide 1 mg or placebo weekly. The main outcome was a composite of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (CV death/MI/stroke) as well as death due to any cause by baseline CKD severity. CKD was categorized by estimated glomerular filtration rate < or ≥60 mL/min/1.73 m2, urine albumin-to-creatinine ratio < or ≥300 mg/g, or Kidney Disease Improving Global Outcomes (KDIGO) risk classification.ResultsThree thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years. Low/moderate KDIGO risk was present in 242 (6.8%), while 878 (24.9%) had high and 2412 (68.3%) had very high KDIGO risk. Semaglutide reduced CV death/MI/stroke by 18% [hazard ratio (HR) 0.82 (95% confidence interval 0.68-0.98); P = .03], with consistency across estimated glomerular filtration rate categories, urine albumin-to-creatinine ratio levels, and KDIGO risk classification (all P-interaction > .13). Death due to any cause was reduced by 20% [HR 0.80 (0.67-0.95); P = .01], with consistency across estimated glomerular filtration rate categories and KDIGO risk class (P-interaction .21 and .23, respectively). The P-interaction treatment effect for death due to any cause by urine albumin-to-creatinine ratio was .01 [<300 mg/g HR 1.17 (0.83-1.65); ≥300 mg/g HR 0.70 (0.57-0.85)].ConclusionsSemaglutide significantly reduced the risk of CV death/MI/stroke regardless of baseline CKD severity in participants with type 2 diabetes.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes and chronic kidney disease, semaglutide reduced CV death, non-fatal MI or non-fatal stroke by 18% versus placebo (HR 0.82).

    In plain wordsIn adults with type 2 diabetes and kidney disease, semaglutide lowered heart-related death, heart attack and stroke compared with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseCV death, non-fatal MI or non-fatal stroke
    Study

    n = 3,533

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Measurements

    HR
    0.82 ratio
    CV death/MI/stroke

    Source sentences

    Summary
    Semaglutide reduced CV death/MI/stroke by 18% [hazard ratio (HR) 0.82 (95% confidence interval 0.68-0.98); P = .03], with consistency across estimated glomerular filtration rate categories, urine albumin-to-creatinine ratio levels, and KDIGO risk classification (all P-interaction > .13).
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes and chronic kidney disease, semaglutide reduced death from any cause by 20% versus placebo (HR 0.80).

    In plain wordsIn adults with type 2 diabetes and kidney disease, semaglutide lowered deaths from any cause compared with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseAll-cause death
    Study

    n = 3,533

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Measurements

    HR
    0.8 ratio
    all-cause death

    Source sentences

    Summary
    Death due to any cause was reduced by 20% [HR 0.80 (0.67-0.95); P = .01], with consistency across estimated glomerular filtration rate categories and KDIGO risk class (P-interaction .21 and .23, respectively).
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.
  3. 03HumanRandomized controlled trialEfficacy outcome

    The reduction in CV death, MI or stroke with semaglutide was consistent across eGFR categories, albuminuria levels and KDIGO risk classes (all P-interaction >.13).

    In plain wordsThe heart benefit of semaglutide over placebo was similar across levels of kidney disease severity.

    Peptide
    Semaglutide
    Outcome
    No significant changeCV outcome effect by CKD severity
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Source sentences

    Summary
    with consistency across estimated glomerular filtration rate categories, urine albumin-to-creatinine ratio levels, and KDIGO risk classification (all P-interaction > .13).
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.
  4. 04HumanRandomized controlled trialEfficacy outcome

    The reduction in all-cause death with semaglutide was consistent across eGFR categories and KDIGO risk classes (P-interaction .21 and .23).

    In plain wordsThe survival benefit of semaglutide over placebo was similar across kidney function levels and risk classes.

    Peptide
    Semaglutide
    Outcome
    No significant changeAll-cause death effect by eGFR and KDIGO class
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Source sentences

    Summary
    with consistency across estimated glomerular filtration rate categories and KDIGO risk class (P-interaction .21 and .23, respectively).
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In participants with urine albumin-to-creatinine ratio below 300 mg/g, semaglutide did not significantly change all-cause death versus placebo (HR 1.17, 95% CI 0.83-1.65).

    In plain wordsIn people with lower urine albumin, semaglutide did not clearly change deaths from any cause compared with placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeAll-cause death, UACR below 300 mg/g
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Measurements

    HR
    1.17 ratio
    UACR <300 mg/g

    Source sentences

    Summary
    The P-interaction treatment effect for death due to any cause by urine albumin-to-creatinine ratio was .01 [<300 mg/g HR 1.17 (0.83-1.65); ≥300 mg/g HR 0.70 (0.57-0.85)].
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In participants with urine albumin-to-creatinine ratio of 300 mg/g or above, semaglutide reduced all-cause death versus placebo (HR 0.70).

    In plain wordsIn people with higher urine albumin, semaglutide lowered deaths from any cause compared with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseAll-cause death, UACR 300 mg/g or above
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Measurements

    HR
    0.7 ratio
    UACR >=300 mg/g

    Source sentences

    Summary
    The P-interaction treatment effect for death due to any cause by urine albumin-to-creatinine ratio was .01 [<300 mg/g HR 1.17 (0.83-1.65); ≥300 mg/g HR 0.70 (0.57-0.85)].
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.
  7. 07HumanRandomized controlled trialEfficacy outcome

    The effect of semaglutide on all-cause death differed by albuminuria level (P-interaction .01).

    In plain wordsThe effect of semaglutide on deaths from any cause differed between people with lower and higher urine albumin.

    Peptide
    Semaglutide
    Outcome
    MixedAll-cause death effect by UACR (interaction)
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Mortality · Cardiovascular
    Studied dose
    1 mg weekly · subcutaneous · median follow-up 3.4 yearsAs given in this study (human).

    Source sentences

    Summary
    The P-interaction treatment effect for death due to any cause by urine albumin-to-creatinine ratio was .01 [<300 mg/g HR 1.17 (0.83-1.65); ≥300 mg/g HR 0.70 (0.57-0.85)].
    2 context sentences
    Summary · context
    Participants were randomized to subcutaneous semaglutide 1 mg or placebo weekly.
    Summary · context
    Three thousand, five hundred and thirty-three participants were randomized with a median follow-up of 3.4 years.

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

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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