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Peptide

Lixisenatide (Adlyxin)

Lixisenatide is a once-daily GLP-1 receptor agonist for type 2 diabetes. FDA-approved 2016 following ELIXA cardiovascular safety trial. GetGoal Phase 3 program (n>5,000): Significant HbA1c reductions across 13 trials. ELIXA (n=6,068): Confirmed CV safety (HR 1.02 for MACE, noninferiority P<0.001). Pronounced postprandial glucose effect - 75% reduction in glucose excursion (GetGoal-Mono). Effective add-on to basal insulin. Common side effects: nausea, vomiting (dose-dependent, resolve in 3-6 weeks).

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Best evidence
Grade A
Conditions studied
1
Outcomes
13
Graded outcomes
5431

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Type 2 Diabetes

Type 2 Diabetes: outcomes studied for Lixisenatide (Adlyxin)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Postprandial Glucose Control

GetGoal-Mono: 75% reduction in postprandial glucose excursion. GetGoal-L: Placebo-corrected PPG reduction of 3.8 mmol/L (P<0.0001). Pronounced prandial effect distinguishes from other GLP-1 RAs.

Improves (the measure goes down)Large effect18 studies

Studies that measured postprandial glucose control

and 8 more in the citations list

Add-on to Basal Insulin

GetGoal-L, GetGoal-L-Asia, GetGoal-Duo: Significant HbA1c and PPG improvements when added to basal insulin. Alternative to prandial insulin without weight gain. Less hypoglycemia than basal-bolus regimens.

Improves (the measure goes up)Moderate effect17 studies

Studies that measured add-on to basal insulin

and 7 more in the citations list

Cardiovascular Safety (MACE)

ELIXA (n=6,068): CV death/MI/stroke/UA hospitalization 13.4% vs 13.2% placebo (HR 1.02, noninferiority P<0.001, superiority P=0.81). No CV harm or benefit. Safe in high-risk post-ACS patients.

NoneNo effect16 studies

Studies that measured cardiovascular safety (mace)

and 6 more in the citations list

HbA1c Reduction

GetGoal program (13 trials, n>5,000): Consistent HbA1c reductions. ELIXA: 0.27% greater reduction vs placebo. GetGoal-L: Significant improvement when added to basal insulin. All trials met primary HbA1c endpoints.

Improves (the measure goes down)Moderate effect14 studies

Studies that measured hba1c reduction

and 4 more in the citations list

Gastrointestinal Side Effects

Most common: Nausea (dose-dependent), vomiting, diarrhea. Generally mild-moderate, resolve within 3-6 weeks. Similar GI profile to other GLP-1 RAs. Gradual dose titration recommended.

Changes; see studiesModerate effect14 studies

Studies that measured gastrointestinal side effects

and 4 more in the citations list

General

General: outcomes studied for Lixisenatide (Adlyxin)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Blood Glucose Control

59 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes down)Moderate effect19 studies

Studies that measured blood glucose control

and 9 more in the citations list

Safety/Tolerability

17 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect15 studies

Studies that measured safety/tolerability

and 5 more in the citations list

Neuroprotection

8 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect14 studies

Studies that measured neuroprotection

and 4 more in the citations list

Body Weight

6 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes down)Small effect12 studies

Studies that measured body weight

and 2 more in the citations list

Anti-Inflammatory Activity

3 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect11 studies

Studies that measured anti-inflammatory activity

and 1 more in the citations list

Kidney Function

4 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect10 studies
Liver Protection

3 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect9 studies
Cardiac Protection

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect8 studies

Key findings

  • Postprandial Glucose ControlType 2 DiabetesImproves (the measure goes down)
  • Add-on to Basal InsulinType 2 DiabetesImproves (the measure goes up)
  • Cardiovascular Safety (MACE)Type 2 Diabetes

Safety notes in the studies

  • Safe in high-risk post-ACS patients.

Studies cited

59 studies from PubMed

  1. Obesity Treatment With Bariatric Surgery vs GLP-1 Receptor Agonists.JAMA surgery, 2025 · PMID 40960852
  2. Are glucagon-like peptide-1 (GLP-1) receptor agonists useful in treating Parkinson's disease (PD)? Does the clinical trial with lixisenatide add anything?Expert opinion on investigational drugs, 2025 · PMID 39864104
  3. Efficacy and safety of GLP-1 agonists in Parkinson's disease: a systematic review and meta-analysis of randomized controlled trials.Naunyn-Schmiedeberg's archives of pharmacology, 2025 · PMID 40067438
  4. Neuroprotective effects of lixisenatide against propagation of α-synuclein pathology in Parkinson's disease.Neural regeneration research, 2025 · PMID 40145958
  5. Association of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and neurogenesis: a systematic review.Acta neuropsychiatrica, 2025 · PMID 39950609
  6. Are Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Central Nervous System (CNS) Penetrant: A Narrative Review.Neurology and therapy, 2025 · PMID 40172827
  7. The effect of subcutaneous Lixisenatide on weight loss in patients with type 2 Diabetes Mellitus: Systematic review and Meta-Analysis of randomized controlled trials.Diabetes research and clinical practice, 2024 · PMID 38490492
  8. The association between glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and suicidality: reports to the Food and Drug Administration Adverse Event Reporting System (FAERS).Expert opinion on drug safety, 2024 · PMID 38087976
  9. Lixisenatide in early parkinson's disease: efficacy, safety, and future directions: a correspondence.Neurosurgical review, 2024 · PMID 38787469
  10. Trial of Lixisenatide in Early Parkinson's Disease.The New England journal of medicine, 2024 · PMID 38598572
  11. GLP-1 Receptor Agonists: A New Treatment in Parkinson's Disease.International journal of molecular sciences, 2024 · PMID 38612620
  12. Glucagon-like peptide-1 class drugs show clear protective effects in Parkinson's and Alzheimer's disease clinical trials: A revolution in the making?Neuropharmacology, 2024 · PMID 38677445
  13. Lixisenatide ameliorated lipopolysaccharide (LPS)-induced expression of mucin and inflammation in bronchial epithelial cells.Journal of biochemical and molecular toxicology, 2024 · PMID 38229325
  14. Rare cutaneous adverse reactions associated with GLP-1 agonists: a review of the published literature.Archives of dermatological research, 2024 · PMID 38795152
  15. Emerging Role of GLP-1 Agonists in Obesity: A Comprehensive Review of Randomised Controlled Trials.International journal of molecular sciences, 2023 · PMID 37445623
  16. Comparison of Efficacy and Safety of Commercially Available Fixed-Ratio Combinations of Insulin Degludec/Liraglutide and Insulin Glargine/Lixisenatide: A Network Meta-analysis.Canadian journal of diabetes, 2023 · PMID 36963632
  17. Retraction Note: Lixisenatide protects doxorubicin-induced renal fibrosis by activating wNF-κB/TNF-α and TGF-β/Smad pathways.European review for medical and pharmacological sciences, 2023 · PMID 37522656
  18. A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes.Pediatric diabetes, 2022 · PMID 35411611
  19. The Durable Safety and Effectiveness of Lixisenatide in Japanese People with Type 2 Diabetes: The Post-Marketing Surveillance PRANDIAL Study.Advances in therapy, 2022 · PMID 35449321
  20. Effects of GLP-1 and Its Analogs on Gastric Physiology in Diabetes Mellitus and Obesity.Advances in experimental medicine and biology, 2021 · PMID 32077010
  21. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled dataDiabetes Ther, 2020 · PMID 31956422
  22. Low-dose lixisenatide protects against early-onset nephropathy induced in diabetic rats.Life sciences, 2020 · PMID 33065146
  23. Lixisenatide Reduced Damage in Hippocampus CA1 Neurons in a Rat Model of Cerebral Ischemia-Reperfusion Possibly Via the ERK/P38 Signaling Pathway.Journal of molecular neuroscience : MN, 2020 · PMID 32040827
  24. Comparison of lixisenatide in combination with basal insulin vs other insulin regimens for the treatment of patients with type 2 diabetes inadequately controlled by basal insulin: Systematic review, network meta-analysis and cost-effectiveness analysis.Diabetes, obesity & metabolism, 2020 · PMID 31469217
  25. Insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with premix or addition of meal-time insulin to basal insulin in people with type 2 diabetes: A systematic review and Bayesian network meta-analysis.Diabetes, obesity & metabolism, 2020 · PMID 32700442
  26. Lixisenatide protects doxorubicin-induced renal fibrosis by activating wNF-κB/TNF-α and TGF-β/Smad pathways.European review for medical and pharmacological sciences, 2019 · PMID 31115031
  27. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trialLancet Diabetes Endocrinol, 2018 · PMID 30292589
  28. PRISMA-efficacy and safety of lixisenatide for type 2 diabetes mellitus: A meta-analysis of randomized controlled trials.Medicine, 2018 · PMID 30572502
  29. Lixisenatide ameliorates cerebral ischemia-reperfusion injury via GLP-1 receptor dependent/independent pathways.European journal of pharmacology, 2018 · PMID 29864411
  30. An Evaluation of the Clinical Therapeutic Effect of Lixisenatide in Type 2 Diabetes Patients: A Systematic Literature Review.Current diabetes reviews, 2018 · PMID 28738763
  31. Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis.The lancet. Diabetes & endocrinology, 2018 · PMID 29221659
  32. Efficacy and safety of lixisenatide in patients with type 2 diabetes and renal impairment.Diabetes, obesity & metabolism, 2017 · PMID 28449324
  33. Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme.Diabetes, obesity & metabolism, 2017 · PMID 27762096
  34. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 TrialDiabetes Care, 2016 · PMID 27222510
  35. Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: An Individual Patient Data Meta-Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders, 2016 · PMID 27796905
  36. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary SyndromeN Engl J Med, 2015 · PMID 26630143
  37. Pronounced reduction of postprandial glucagon by lixisenatide: a meta-analysis of randomized clinical trialsDiabetes Obes Metab, 2015 · PMID 24641271
  38. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placeboAm Heart J, 2015 · PMID 25965710
  39. Effects of the GLP-1 receptor agonist lixisenatide on postprandial glucose and gastric emptying--preclinical evidence.Journal of diabetes and its complications, 2014 · PMID 23992745
  40. Lixisenatide, a novel GLP-1 receptor agonist: efficacy, safety and clinical implications for type 2 diabetes mellitus.Diabetes, obesity & metabolism, 2014 · PMID 24373190
  41. Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes.Diabetes/metabolism research and reviews, 2014 · PMID 24687427
  42. Lixisenatide improves recognition memory and exerts neuroprotective actions in high-fat fed mice.Peptides, 2014 · PMID 25195184
  43. Effects of lixisenatide on elevated liver transaminases: systematic review with individual patient data meta-analysis of randomised controlled trials on patients with type 2 diabetes.BMJ open, 2014 · PMID 25526792
  44. A systematic review and meta-analysis of the efficacy of lixisenatide in the treatment of patients with type 2 diabetes.Diabetes, obesity & metabolism, 2014 · PMID 24476092
  45. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis.Journal of diabetes and its complications, 2014 · PMID 25130920
  46. Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials.Advances in therapy, 2014 · PMID 25143188
  47. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L)Diabetes Care, 2013 · PMID 23628617
  48. Mechanisms and clinical efficacy of lixisenatide for the management of type 2 diabetesAdv Ther, 2013 · PMID 23423907
  49. Lixisenatide: a review of its use in patients with type 2 diabetes mellitus.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2013 · PMID 23918699
  50. Lixisenatide for the treatment of type 2 diabetes.Drugs of today (Barcelona, Spain : 1998), 2013 · PMID 24086950
  51. Pharmacological profile, efficacy and safety of lixisenatide in type 2 diabetes mellitus.Expert opinion on pharmacotherapy, 2013 · PMID 24087882
  52. Lixisenatide as add-on therapy to basal insulin.Drug design, development and therapy, 2013 · PMID 24363554
  53. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono)Diabetes Care, 2012 · PMID 22432104
  54. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia)Diabetes Obes Metab, 2012 · PMID 22564709
  55. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus.Nature reviews. Endocrinology, 2012 · PMID 22945360
  56. Effects of glucagon-like peptide-1 receptor agonists on body weight: a meta-analysis.Experimental diabetes research, 2012 · PMID 22675341
  57. Lixisenatide for type 2 diabetes mellitus.Expert opinion on investigational drugs, 2011 · PMID 21391833
  58. Pharmacological profile of lixisenatide: A new GLP-1 receptor agonist for the treatment of type 2 diabetes.Regulatory peptides, 2010 · PMID 20570597
  59. Lixisenatide, a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus.IDrugs : the investigational drugs journal, 2009 · PMID 19629885