Effect of semaglutide on kidney outcomes in the SELECT, FLOW, and SOUL trials: a prespecified pooled analysis.

Mann JFE, Badve SV, Baeres FMM, Belmar N, Brown-Frandsen K, Buse JB, Colhoun HM, Deanfield JE, Engelmann MDM, Hovingh GK, Idorn T, Lincoff AM and 9 more

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Lingvay I, Mahaffey KW, McGuire DK, Pratley RE, Rasmussen S, Rossing P, Sattar N, Tuttle KR, Perkovic V

The lancet. Diabetes & endocrinology7 Aug 2026Cited by 1 (Europe PMC)

PMID42567173DOI10.1016/s2213-8587(26)00134-8PepBankPUB-42567173

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Summary

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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.

01HumanRandomized controlled trialEfficacy outcome
In 30 787 people with CKD or atherosclerotic cardiovascular disease, semaglutide reduced first events of the primary kidney composite versus placebo (HR 0.84).
In plain wordsIn people with kidney disease or heart disease, semaglutide lowered the risk of serious kidney outcomes compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseKidney composite (50% eGFR decline, kidney failure, kidney or cardiovascular death)
Study
n = 30,787
Comparator
Placebo
Analysis
Primary
Outcome group
Kidney function · Kidney and urinary
Studied dose
1.0 mg weekly (FLOW), 2.4 mg weekly (SELECT), 14 mg daily oral (SOUL) · subcutaneous or oral · mean follow-up 39·5-47·5 monthsAs given in this study (human).
Measurements
Hazard ratio
0.84
semaglutide vs placebo, primary kidney composite
Source sentences
Summary
Among participants assigned to semaglutide, 973 first events of the primary kidney composite occurred compared with 1134 first events for placebo (hazard ratio [HR] 0·84 [95% CI 0·77-0·91]).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with CKD (FLOW) or atherosclerotic cardiovascular disease (SELECT and SOUL) were randomly assigned semaglutide (once-weekly subcutaneous 1·0 mg [FLOW], once-weekly subcutaneous 2·4 mg [SELECT], or once-daily oral 14 mg [SOUL]) or matching placebo, added to standard of care.
Report a problemFND-4256717301
02HumanRandomized controlled trialEfficacy outcome
In 30 787 people with CKD or atherosclerotic cardiovascular disease, semaglutide reduced first events of the narrower secondary kidney composite versus placebo (HR 0.80).
In plain wordsIn people with kidney disease or heart disease, semaglutide lowered the risk of a narrower set of kidney outcomes compared with placebo.
Peptide
Semaglutide
Outcome
DecreaseNarrower kidney composite (excluding cardiovascular death)
Study
n = 30,787
Comparator
Placebo
Analysis
Secondary
Outcome group
Kidney function · Kidney and urinary
Studied dose
1.0 mg weekly (FLOW), 2.4 mg weekly (SELECT), 14 mg daily oral (SOUL) · subcutaneous or oral · mean follow-up 39·5-47·5 monthsAs given in this study (human).
Measurements
Hazard ratio
0.8
semaglutide vs placebo, narrower kidney composite
Source sentences
Summary
First events of a narrower secondary kidney composite (excluding cardiovascular-related death from the primary outcome) were also reduced with semaglutide versus placebo (347 and 416, respectively; 0·80 [0·69-0·92]).
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with CKD (FLOW) or atherosclerotic cardiovascular disease (SELECT and SOUL) were randomly assigned semaglutide (once-weekly subcutaneous 1·0 mg [FLOW], once-weekly subcutaneous 2·4 mg [SELECT], or once-daily oral 14 mg [SOUL]) or matching placebo, added to standard of care.
Report a problemFND-4256717302
03HumanRandomized controlled trialSafety outcome
In pooled participants from SELECT, FLOW and SOUL, safety outcomes were overall similar between semaglutide and placebo.
In plain wordsIn three large trials, safety outcomes with semaglutide were similar to those with placebo.
Peptide
Semaglutide
Outcome
No significant changeOverall safety outcomes
Study
n = 30,787
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg weekly (FLOW), 2.4 mg weekly (SELECT), 14 mg daily oral (SOUL) · subcutaneous or oral · mean follow-up 39·5-47·5 monthsAs given in this study (human).
Source sentences
Summary
Safety outcomes were overall similar between groups, and in line with other GLP-1 receptor agonist trials.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with CKD (FLOW) or atherosclerotic cardiovascular disease (SELECT and SOUL) were randomly assigned semaglutide (once-weekly subcutaneous 1·0 mg [FLOW], once-weekly subcutaneous 2·4 mg [SELECT], or once-daily oral 14 mg [SOUL]) or matching placebo, added to standard of care.
Report a problemFND-4256717303
04HumanRandomized controlled trialSafety outcome
In pooled participants from SELECT, FLOW and SOUL, serious adverse events were numerically lower with semaglutide than with placebo.
In plain wordsIn three large trials, serious adverse events were numerically lower with semaglutide than with placebo.
Peptide
Semaglutide
Outcome
DecreaseSerious adverse events
Study
n = 30,787
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg weekly (FLOW), 2.4 mg weekly (SELECT), 14 mg daily oral (SOUL) · subcutaneous or oral · mean follow-up 39·5-47·5 monthsAs given in this study (human).
Source sentences
Summary
Serious adverse events were numberically lower with semaglutide than with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants with CKD (FLOW) or atherosclerotic cardiovascular disease (SELECT and SOUL) were randomly assigned semaglutide (once-weekly subcutaneous 1·0 mg [FLOW], once-weekly subcutaneous 2·4 mg [SELECT], or once-daily oral 14 mg [SOUL]) or matching placebo, added to standard of care.
Report a problemFND-4256717304

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.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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