Safety issues with glucagon‐like peptide‐1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): D ata from randomized controlled trials
Abstract
AIM: Glucagon-like peptide 1 receptor agonists (GLP1-RA) have been associated with an increased risk of pancreatitis and pancreatic cancer. Prior meta-analyses of randomized controlled trials failed to show any significant increase of risk; however, those meta-analyses did not include the recently published cardiovascular outcome trials (CVOT) with GLP1-RA, which provide a substantial additional body of data. The aim of the present meta-analysis is to assess the effect of GLP1-RA on pancreatitis, pancreatic cancers and cholelithiasis. MATERIALS AND METHODS: A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide or semaglutide) was performed, collecting all randomized clinical trials with a duration >11 weeks, enrolling patients with type 2 diabetes and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. RESULTS: Of the 113 trials fulfilling inclusion criteria, 13 did not report information on pancreatitis, whereas 72 reported no events in all treatment groups. The incidence of pancreatitis and pancreatic cancer with GLP1-RA was not significantly different from that observed in comparator arms (MH-OR [95% CI] 0.93 [0.65-1.34], P = .71, and 0.94 [0.52-1.70], P = .84, respectively), whereas, a significantly increased risk of cholelithiasis (MH-OR [95% CI] 1.30 [1.01-1.68], P = .041) was detected. CONCLUSIONS: Presently available data confirm the safety of GLP-1 receptor agonists for pancreatitis. Conversely, therapy with those drugs is associated with an increased risk of cholelithiasis, which deserves further investigation.
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The same meta-analysis of 113 RCTs identified a notable increase in cholelithiasis risk (MH-OR 1.30).
“A meta-analysis of 113 RCTs comprising 33,167 patients in the GLP-1 RA cohort and 26,683 in the comparator cohort revealed no significant elevation in pancreatitis or pancreatic cancer risk relative to control groups (Mantel-Haenszel odds ratio [MH-OR] of 0.93 and 0.94, respectively), but identified a notable increase in cholelithiasis risk (MH-OR, 1.30) [58].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [58]
A meta-analysis of 113 RCTs comprising 33,167 patients in the GLP-1 RA cohort and 26,683 in the comparator cohort revealed no significant elevation in pancreatitis or pancreatic cancer risk relative to control groups (MH-OR 0.93 and 0.94, respectively).
“A meta-analysis of 113 RCTs comprising 33,167 patients in the GLP-1 RA cohort and 26,683 in the comparator cohort revealed no significant elevation in pancreatitis or pancreatic cancer risk relative to control groups (Mantel-Haenszel odds ratio [MH-OR] of 0.93 and 0.94, respectively), but identified a notable increase in cholelithiasis risk (MH-OR, 1.30) [58].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [58]
Monami et al. found that GLP-1 RAs significantly increase the risk of gallstone disease in patients with T2DM.
“On the contrary, Monami et al. found that GLP-1RAs significantly increase the risk of gallstone disease in patients with T2DM [61].”
From Gastrointestinal adverse events associated with GLP-1 RA in non-diabetic patients with overweight or obesity: a systematic review and network meta-analysis (2025) · cites this paper as [61]
Large-scale real-world studies indicate that GLP-1 class drugs may cause severe adverse reactions, such as acute pancreatitis, cholelithiasis, and acute kidney injury.
“Additionally, large-scale real-world studies indicate that GLP-1 class drugs may cause severe adverse reactions, such as acute pancreatitis, cholelithiasis, and acute kidney injury [[32], [33], [34], [35]].”
From Comparative efficacy and safety of GLP-1 receptor agonists for weight reduction: A model-based meta-analysis of placebo-controlled trials (2025) · cites this paper as [33]
Recent meta-analyses of randomized control trials indicate the lack of signals related to increased risk of pancreatic and breast cancer in subjects treated with GLP-1 RAs either for T2D or obesity.
“In contrast, recent meta-analyses of randomized control trials indicate the lack of signals related to the increase in the risk of pancreatic and breast cancer, in subjects treated with GLP-1 RAs either for T2D or for obesity [133].”
From Adipose Tissue: A Novel Target of the Incretin Axis? A Paradigm Shift in Obesity-Linked Insulin Resistance (2024) · cites this paper as [133]
Long-term trials reported that the risk of acute pancreatitis does not notably increase with liraglutide use.
“Initially, there were concerns about the risk of acute pancreatitis; however, long-term trials reported that the risk does not notably increase with the use of liraglutide [52, 53].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [52]
The overall risk of malignant and benign neoplasms was higher in the liraglutide group than in the placebo group.
“However, the overall risk of malignant and benign neoplasms was higher in the liraglutide group than in the placebo group [52, 53, 59].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [52]
Nreu et al. and Monami et al. found that the incidence of pancreatitis and pancreatic cancer with GLP-1 receptor agonists including semaglutide was not significantly different from that observed in comparator arms.
“Both Nreu et al. (39), Monami et al. (40) found that the incidence of pancreatitis and pancreatic cancer with GLP-1 RAs including semaglutide was not significant from that observed in comparator arms.”
From Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system (2022) · cites this paper as [40]
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- Authors
- Monami, M., Nreu, B., Scatena, A., Cresci, B., Andreozzi, F., Sesti, G., & Mannucci, E.
- Affiliations
- Azienda Ospedaliero-Universitaria Careggi (IT)
- Ospedale San Donato (IT)
- Magna Graecia University (IT)
- Corresponding author
- Monami, Matteo
- ORCID
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2017-06-20
- Volume
- 19
- Issue
- 9
- Pages
- 1233-1241
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W2592954074
- Semantic Scholar
- dc85c171f21d7b3aa05890175d1c0c6ffb132a12
- Cited by
- 243
- References
- 38
- Citations by year
- 2026: 26 · 2025: 34 · 2024: 31 · 2023: 26 · 2022: 26 · 2021: 25 · 2020: 21 · 2019: 24 · 2018: 19 · 2017: 11
- FWCI
- 2.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Florence Research (University of Florence) (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Keywords
- GLP-1 receptor agonists, pancreatitis, pancreatic cancer, gallstones, drug safety, type 2 diabetes, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide, cardiovascular outcome trials
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Glucagon-Like Peptide-1 Receptor Agonists, Biliary Tract, Cholelithiasis, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Pancreas, Pancreatic Neoplasms, Pancreatitis, Risk, Reproducibility of Results, Incidence, Randomized Controlled Trials as Topic, Evidence-Based Medicine
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