Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial.

Mann JFE, Marx N, Deanfield JE, Emerson SS, Inzucchi SE, McGuire DK, Mulvagh SL, Pop-Busui R, Poulter NR, Engelmann MDM, Hovingh GK, Belmar N and 10 more

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Idorn T, Jeppesen OK, Birkenfeld AL, Amod A, Mankovsky B, Desouza C, Gorgojo-Martinez JJ, Arechavaleta R, Tu ST, Buse JB

Diabetes care1 Feb 2026Cited by 9 (Europe PMC)

PMID41380027PMCIDPMC12824789DOI10.2337/dc25-1080PepBankPUB-41380027

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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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease, oral semaglutide did not significantly reduce the five-point kidney composite versus placebo (HR 0.91; P = 0.19).
In plain wordsIn people with type 2 diabetes and heart or kidney disease, oral semaglutide did not clearly lower serious kidney events more than placebo.
Peptide
Semaglutide
Outcome
No significant changeFive-point kidney composite outcome
Study
n = 9,650
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
Hazard ratio
0.91 ratio
oral semaglutide vs placebo, five-point outcome
Participants with event
8.4%
oral semaglutide
Participants with event
9%
placebo
Source sentences
Summary
The five-point outcome occurred in 403 (8.4%) and 435 (9.0%) participants taking oral semaglutide versus placebo, respectively (hazard ratio [HR] 0.91; 95% CI 0.80, 1.05; P = 0.19).
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the effects of oral semaglutide on kidney outcomes in people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Summary · context
Among 9,650 participants, mean eGFR was 73.8 mL/min/1.73 m2, and follow-up was 47.5 months.
Report a problemFND-4138002701
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease, oral semaglutide did not significantly reduce the four-point kidney composite versus placebo (HR 0.86; P = 0.22).
In plain wordsIn people with type 2 diabetes and heart or kidney disease, oral semaglutide did not clearly lower the four-point kidney outcome more than placebo.
Peptide
Semaglutide
Outcome
No significant changeFour-point kidney composite outcome
Study
n = 9,650
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
Hazard ratio
0.86 ratio
oral semaglutide vs placebo, four-point outcome
Participants with event
2.3%
oral semaglutide
Participants with event
2.7%
placebo
Source sentences
Summary
The four-point outcome occurred in 112 (2.3%) and 129 (2.7%) participants, respectively (HR 0.86; 95% CI 0.66, 1.10; P = 0.22).
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the effects of oral semaglutide on kidney outcomes in people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Summary · context
Among 9,650 participants, mean eGFR was 73.8 mL/min/1.73 m2, and follow-up was 47.5 months.
Report a problemFND-4138002702
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease, oral semaglutide slowed annual eGFR decline versus placebo (-1.67 vs -2.06 mL/min/1.73 m2; P < 0.0001).
In plain wordsIn people with type 2 diabetes and heart or kidney disease, kidney filtering fell more slowly with oral semaglutide than with placebo.
Peptide
Semaglutide
Outcome
DecreaseMean annual eGFR decline
Study
n = 9,650
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
Mean annual eGFR decline
−1.67 mL/min/1.73 m2
oral semaglutide
Mean annual eGFR decline
−2.06 mL/min/1.73 m2
placebo
Estimated treatment difference
0.4 mL/min/1.73 m2
oral semaglutide vs placebo
Source sentences
Summary
Mean annual eGFR decline was less with oral semaglutide than placebo (-1.67 vs. -2.06 mL/min/1.73 m2; estimated treatment difference 0.40 [95% CI 0.27, 0.53; P < 0.0001).
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the effects of oral semaglutide on kidney outcomes in people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Summary · context
Among 9,650 participants, mean eGFR was 73.8 mL/min/1.73 m2, and follow-up was 47.5 months.
Report a problemFND-4138002703
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, serious adverse events occurred at similar rates with oral semaglutide and placebo.
In plain wordsIn people with type 2 diabetes, serious side effects were about as common with oral semaglutide as with placebo.
Peptide
Semaglutide
Outcome
No significant changeSerious adverse events
Study
n = 9,650
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
Serious adverse events occurred at similar rates in both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
To examine the effects of oral semaglutide on kidney outcomes in people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Summary · context
Among 9,650 participants, mean eGFR was 73.8 mL/min/1.73 m2, and follow-up was 47.5 months.
Report a problemFND-4138002705
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the kidney effects of oral semaglutide were similar across most prespecified subgroups, including baseline eGFR below 60 mL/min/1.73 m2.
In plain wordsIn people with type 2 diabetes, oral semaglutide had similar kidney effects across most subgroups, including people with lower kidney function.
Peptide
Semaglutide
Outcome
Not applicableKidney effects in subgroups including baseline eGFR below 60
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
These effects were similar across most subgroups, including those with eGFR <60 mL/min/1.73 m2.
3 context sentences(design, population, supporting numbers)
Summary · context
Prespecified subgroups were also assessed, including those with eGFR <60 mL/min/1.73 m2 at baseline.
Summary · context
To examine the effects of oral semaglutide on kidney outcomes in people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Summary · context
Among 9,650 participants, mean eGFR was 73.8 mL/min/1.73 m2, and follow-up was 47.5 months.
Report a problemFND-4138002704

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03914326

A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Novo Nordisk A/Sn = 9,65117 Jun 2019 to 23 Aug 2024

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 11 Dec 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.

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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Terms as the source lists them.

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