Risk of neoplasms with semaglutide in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

Zhong Y, Tan X, Zhang L, Wu C

Frontiers in pharmacology3 Sept 2026

PMID42757217PMCIDPMC13584767DOI10.3389/fphar.2026.1916932PepBankPUB-42757217

Summary

BackgroundSemaglutide is prescribed in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes (T2DM). However, its potential impact on tumorigenesis has prompted considerable debate.MethodsThe meta-analysis was conducted in accordance with PRISMA 2020 guidelines. We searched Web of Science, PubMed, Embase, and ScienceDirect for eligible randomized controlled trials (RCTs). The outcome was the risk of overall, benign and malignant neoplasms. The pooled results were expressed as odds ratio (OR) with 95% confidence interval (95% CI). Influential publication was determined by performing the sensitivity analysis. Publication bias was assessed using the funnel plot, Begg's and Egger's tests.ResultsNineteen RCTs conducted between 2016 and 2025 were included, enrolling of 38,160 patients with T2DM. The interventions involved subcutaneous semaglutide and oral semaglutide, with treatment durations ranging from 26 to 156 weeks. Fixed-effects meta-analysis revealed that semaglutide use was associated with an increased risk of overall neoplasms (OR = 1.19, 95% CI = 1.07 to 1.32, P = 0.001) and benign neoplasms (OR = 1.28, 95% CI = 1.02 to 1.61, P = 0.032), but showed no significant association with malignant neoplasms (OR = 1.12, 95% CI = 1.00 to 1.26, P = 0.054). No influential publications or significant publication bias were detected.ConclusionSemaglutide use in patients with T2DM is associated with a modestly increased risk of overall and benign neoplasms, but not malignant neoplasms. These findings highlight the importance of maintaining clinical awareness regarding potential neoplastic risks, and further long-term RCTs are warranted to clarify their clinical significance.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420261354386, Identifier CRD420261354386.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanSystematic reviewSafety outcome
In a meta-analysis of randomized trials in type 2 diabetes, semaglutide was associated with an increased risk of overall neoplasms.
In plain wordsIn a pooled analysis of trials in type 2 diabetes, semaglutide was linked to a higher risk of tumours overall.
Peptide
Semaglutide
Outcome
IncreaseRisk of overall neoplasms
Study
n = 38,160
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · subcutaneous and oral · 26 to 156 weeksAs given in this study (human).
Measurements
Odds ratio
1.19
overall neoplasms
Source sentences
Summary
Fixed-effects meta-analysis revealed that semaglutide use was associated with an increased risk of overall neoplasms (OR = 1.19, 95% CI = 1.07 to 1.32, P = 0.001)
2 context sentences(design, population, supporting numbers)
Summary · context
Nineteen RCTs conducted between 2016 and 2025 were included, enrolling of 38,160 patients with T2DM.
Summary · context
The interventions involved subcutaneous semaglutide and oral semaglutide, with treatment durations ranging from 26 to 156 weeks.
Show in the study text Report a problemFND-4275721701
02HumanSystematic reviewSafety outcome
In a meta-analysis of randomized trials in type 2 diabetes, semaglutide was associated with an increased risk of benign neoplasms.
In plain wordsIn a pooled analysis of trials in type 2 diabetes, semaglutide was linked to a higher risk of non-cancerous tumours.
Peptide
Semaglutide
Outcome
IncreaseRisk of benign neoplasms
Study
n = 38,160
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · subcutaneous and oral · 26 to 156 weeksAs given in this study (human).
Measurements
Odds ratio
1.28
benign neoplasms
Source sentences
Summary
benign neoplasms (OR = 1.28, 95% CI = 1.02 to 1.61, P = 0.032)
2 context sentences(design, population, supporting numbers)
Summary · context
Nineteen RCTs conducted between 2016 and 2025 were included, enrolling of 38,160 patients with T2DM.
Summary · context
The interventions involved subcutaneous semaglutide and oral semaglutide, with treatment durations ranging from 26 to 156 weeks.
Show in the study text Report a problemFND-4275721702
03HumanSystematic reviewSafety outcome
In a meta-analysis of randomized trials in type 2 diabetes, semaglutide showed no significant association with malignant neoplasms.
In plain wordsIn a pooled analysis of trials in type 2 diabetes, semaglutide was not significantly linked to cancerous tumours.
Peptide
Semaglutide
Outcome
No significant changeRisk of malignant neoplasms
Study
n = 38,160
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · subcutaneous and oral · 26 to 156 weeksAs given in this study (human).
Measurements
Odds ratio
1.12
malignant neoplasms
Source sentences
Summary
but showed no significant association with malignant neoplasms (OR = 1.12, 95% CI = 1.00 to 1.26, P = 0.054)
2 context sentences(design, population, supporting numbers)
Summary · context
Nineteen RCTs conducted between 2016 and 2025 were included, enrolling of 38,160 patients with T2DM.
Summary · context
The interventions involved subcutaneous semaglutide and oral semaglutide, with treatment durations ranging from 26 to 156 weeks.
Show in the study text Report a problemFND-4275721703

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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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