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Subcutaneous · GLP-1 agonist

Lixisenatide

79 trials in this molecule. Source: ClinicalTrials.gov, as of July 1, 2026.

Trials

79

Active

9

Recruiting

1

Completed

57

Sites

2,091

Countries

63

Endpoints

906

Composite endpoints

82

Distinct sites and countries across this molecule's trials. A site running several of its trials counts once, matching the map.

Development

Where the program stands

Trials by phase

Phase 1
6
Phase 1/2
1
Phase 2
7
Phase 3
33
Phase 4
22
Not applicable
10

Trials by status

Not yet recruiting
3
By invitation
2
Recruiting
1
Active, not recruiting
3
Completed
57
Terminated
6
Unknown
7

Evidence coverage

What this asset has been measured on

Endpoints grouped into outcome categories, ranked by how often they are measured across this asset's trials.

Glycemic / diabetes
498
Safety / tolerability / PK
143
Weight & body composition
89
Other (unclassified)
46
Cardiometabolic biomarkers
34
Cardiovascular outcomes
25
Other clinical outcomes
22
Patient-reported / QoL
20
Renal / kidney
15
MASH / liver
10
Heart failure
4

Most-measured metrics

Top 20 metrics across this asset's endpoints

Postprandial glucoseGlycemic

81

HbA1c <7.0% achievementGlycemic

76

HbA1c, changeGlycemic

63

Body weight, absolute change (kg)Weight

53

Fasting glucose, changeGlycemic

50

Documented hypoglycemiaSafety/PK

44

Treatment-emergent AEs (any)Safety/PK

25

HbA1c <6.5% achievementGlycemic

18

C-peptide AUCGlycemic

16

CGM time-in-rangeGlycemic

15

≥5% weight-loss respondersWeight

11

CGM time-above-rangeGlycemic

8

Immunogenicity (ADA)Safety/PK

8

Severe hypoglycemiaSafety/PK

6

Waist circumference, changeWeight

6

Heart rate, changeBiomarker

5

AUC₀–∞Safety/PK

4

Total fat massWeight

4

BMI, changeWeight

3

eGFR, changeRenal

3

Trials

Programs for this asset

Every trial for this molecule, with the same search, filters, and sort as the Trials tab.

79 of 79

Asset / PopulationKey I/E criterionEvidence
ELIXAEvaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

Lixisenatide

Cardiovascular disease, Type 2 diabetes

Ph 3Completed829Feb 201512results
LixiLan-OEfficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

Lixisenatide

Type 2 diabetes

Ph 3Completed273Jun 20158results
LixiLan-LEfficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

Lixisenatide

Type 2 diabetes

Ph 3Completed236Jul 201510results
GetGoal-Duo-2Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

Lixisenatide

Type 2 diabetes

Ph 3Completed199Dec 20143results
GETGOAL-PGLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

Lixisenatide

Type 2 diabetes

Ph 3Completed150Jun 20111results
GetGoal-Duo124-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Lixisenatide

Type 2 diabetes

Ph 3Completed140Aug 20116results
LixiLan-GEfficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

Albiglutide, Dulaglutide, Exenatide, GLP-1 / incretin class catch-all, Liraglutide, Lixisenatide

Type 2 diabetes

Ph 3Completed124May 20185results
LIXILAN JP-LEfficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Lixisenatide

Type 2 diabetes

Ph 3Completed122Oct 20181
LIXILAN JP-O2Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Lixisenatide

Type 2 diabetes

Ph 3Completed113Mar 20181
NCT0097693724-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

Lixisenatide

Obesity / overweight, Type 2 diabetes

BMI ≤50Ph 3Completed92Mar 2011results
LixiLan-DEfficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

Lixisenatide

Type 2 diabetes

HbA1c 7.5-10%Ph 3Terminated85Jan 2019results
GetGoal-OEfficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

Lixisenatide

Type 2 diabetes

Age ≥70Ph 3Completed83Feb 20152results
NCT01517412Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Lixisenatide

Type 2 diabetes

Ph 3Completed82May 20131results
Lixilan-O-APEvaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

Lixisenatide

Type 2 diabetes

Ph 3Completed79Mar 20212
NCT01476475Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Lixisenatide

Type 2 diabetes

Ph 2Completed70Dec 20121results
LIRA-LIXI™Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

Liraglutide, Lixisenatide

Type 2 diabetes

BMI ≥20Ph 4Completed61Nov 20142results
LIXILAN JP-O1Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Lixisenatide

Type 2 diabetes

Ph 3Completed61May 20181
NCT05413369iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

Lixisenatide

Type 2 diabetes

BMI ≤40Ph 3Completed60Oct 2023results
NCT01632163Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Lixisenatide

Type 2 diabetes

Ph 3Completed51May 20152
Lixilan-L-CNComparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

Lixisenatide

Type 2 diabetes

Ph 3Completed45Dec 20203
GetGoal-M-AsiaEfficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Lixisenatide

Type 2 diabetes

Ph 3Completed35Dec 20112results
LixilanOne CANStudy Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

Lixisenatide

Type 2 diabetes

BMI 20-40Ph 3Completed32Oct 20202
NCT01960179Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

Lixisenatide

Type 2 diabetes

Ph 3Completed30Mar 2015
NCT01940965Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Lixisenatide

Type 2 diabetes

Ph 3Completed27Jul 2015
NCT02200991Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

Lixisenatide

Type 2 diabetes

HbA1c 7-10%Ph 4Completed20Nov 20151
LixiParkStudy to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease

Lixisenatide

Parkinson's disease

Ph 2Completed20Apr 20211
GETGOAL-XGLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Exenatide, GLP-1 / incretin class catch-all, Lixisenatide

Type 2 diabetes

Ph 3Completed18Nov 20102results
Soli-CGMEffect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

Lixisenatide

Type 2 diabetes

HbA1c 9-13%Ph 4Completed18Mar 2023results
GETGOAL-MGLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Lixisenatide

Type 2 diabetes

Ph 3Completed16Mar 20114results
GETGOAL-SGLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

Lixisenatide

Type 2 diabetes

Ph 3Completed16Jan 20114results
LixiRamSafety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

Lixisenatide

Type 2 diabetes

Ph 4Completed16Aug 20172
GETGOAL-LGLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

Lixisenatide

Type 2 diabetes

Ph 3Completed15Feb 20114results
GETGOAL-F1GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Lixisenatide

Type 2 diabetes

Ph 3Completed15Jan 20113results
NCT03529123Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

Lixisenatide

Type 2 diabetes

BMI 19-40Ph 3Completed13Nov 2019
GETGOAL-MONOGLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

Lixisenatide

Type 2 diabetes

Ph 3Completed12Dec 20092results
NCT02803918A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

Lixisenatide

Obesity / overweight, Type 2 diabetes

HbA1c 6.5-11%Ph 1Completed11Jan 20201
SEVERALSEMAGLUTIDE VERSUS GLP-1 RECEPTOR AGONISTS. EFFECTIVENESS , SAFETY AND QUALITY OF LIFE IN PATIENTS WITH DIABETES MELLITUS 2. OBSERVATIONAL, PROSPECTIVE AND MULTICENTER STUDY. SEVERAL STUDY.

Dulaglutide, Exenatide, GLP-1 / incretin class catch-all, Liraglutide, Lixisenatide, Semaglutide

Obesity / overweight, Type 2 diabetes

BMI ≥30Completed11Nov 202314
NCT06716424A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus

Lixisenatide

Type 2 diabetes

BMI ≥25Ph 4Active, not recruiting10Jun 2026
NCT01596504Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

Liraglutide, Lixisenatide

Type 2 diabetes

BMI 20-40Ph 2Completed8Jul 20131results
REMIT-iGLRemission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi

Lixisenatide

Type 2 diabetes

HbA1c 6.5-9.5%Ph 3Completed8Jun 2019
NCT00299871Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

Lixisenatide

Type 2 diabetes

BMI 25-40Ph 2Completed7Aug 20071
NCT01175473Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

Liraglutide, Lixisenatide

Type 2 diabetes

Ph 2Completed7Nov 20101results
GLP-1REWINGLP-1 REceptor Agonists and Real World EvIdeNce

Dulaglutide, Exenatide, Liraglutide, Lixisenatide

Type 2 diabetes

Unknown6Feb 20196
NCT01572649Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

Lixisenatide

Type 2 diabetes

HbA1c 7-10%Ph 1Completed6Mar 2014
GETGOAL-L-ASIAGLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)

Lixisenatide

Type 2 diabetes

Ph 3Completed4Jun 20103results
VARIATION 2 SAThe Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians

Lixisenatide

Type 2 diabetes

BMI 20-40Ph 4Completed3Nov 201922
NCT02231658Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

Liraglutide, Lixisenatide

Type 2 diabetes

Ph 1Terminated2Jul 20181
NCT01910194Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying

Lixisenatide

Type 2 diabetes

Ph 2Completed2Oct 2014
CER-4-T2DComparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study

Albiglutide, Dulaglutide, Exenatide, Liraglutide, Lixisenatide, Semaglutide

Type 2 diabetes

Active, not recruiting1May 2026
NCT06449235Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh

Albiglutide, Dulaglutide, Exenatide, GLP-1 / incretin class catch-all, Liraglutide, Lixisenatide, Semaglutide

Type 2 diabetes

HbA1c 7-10%Ph 4Not yet recruiting1Apr 2025
China Soli-CGMiGlarLixi CGM Study in Chinese T2D Individuals After OADs

Lixisenatide

Type 2 diabetes

BMI 20-40Ph 4Recruiting1Sep 2026
NCT07117240Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes

Lixisenatide

Diabetes (other / unspecified), Type 2 diabetes

Ph 4By invitation1Feb 2028
DASH-CKMHUsing Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

Albiglutide, Dulaglutide, Exenatide, Liraglutide, Lixisenatide, Semaglutide, Tirzepatide

Metabolic syndrome

Active, not recruiting1Jun 2029
NCT07274644Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease

Lixisenatide

MASH / NAFLD / liver fibrosis, Type 2 diabetes

BMI 25-35Ph 4By invitation1May 2026
GETGOAL-MONOGLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)

Lixisenatide

Type 2 diabetes

Ph 3Completed1Jan 20111results
NCT01146678Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

Lixisenatide

Type 1 diabetes

HbA1c ≤9%Ph 1Completed1Sep 2010
NCT02020629Study on Lixisenatide and Counterregulation to Hypoglycemia

Lixisenatide

Type 2 diabetes

HbA1c ≤10%Ph 4Completed1Aug 20141
NCT02049034Lixisenatide-The Effects on Glucose and Lipid Metabolism in Type 2 Diabetes

Lixisenatide

Type 2 diabetes

BMI 27-40Ph 4Completed1Jan 20161
LixiBITFeasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin

Lixisenatide

Type 2 diabetes

HbA1c 7-10%Ph 3Completed1Jul 20151results
NCT02244164Pathophysiological Study of the Increase in Pancreatic Volume in Type 2 Diabetes Treatments.

Exenatide, Liraglutide, Lixisenatide

Type 2 diabetes

BMI 20-45Not applicableTerminated1Feb 20234
ELIXIRSEffect of LIXIsenatide on the Renal System

Lixisenatide

Type 2 diabetes

BMI ≥25Ph 4Completed1Apr 20161
LixiDrug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

Lixisenatide

Healthy volunteers, Type 2 diabetes

BMI 19-30Ph 1/2Unknown1Apr 201638
EGLIPAThe Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)

Exenatide, Liraglutide, Lixisenatide

Type 2 diabetes

Ph 4Unknown1Jul 20153
NCT02713477Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

Lixisenatide

Type 2 diabetes

BMI ≤35Ph 1Completed1Jun 20161
NCT02767596Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog

Lixisenatide

Type 2 diabetes

Ph 4Terminated1Feb 2017
NCT03492580A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Albiglutide, Dulaglutide, Exenatide, GLP-1 / incretin class catch-all, Liraglutide, Lixisenatide

Cardiovascular disease, Type 2 diabetes

Established CVDCompleted1Apr 2018
Lixibrain01Effects of Insulin Glargine and Lixisenatide on the Brain

Lixisenatide

Obesity / overweight, Type 2 diabetes

BMI 25-45Ph 4Terminated1Jun 2020
NCT04184947Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists

Dulaglutide, Exenatide, GLP-1 / incretin class catch-all, Liraglutide, Lixisenatide

Type 2 diabetes

Completed1Dec 20181
BEYONDDurability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)

GLP-1 / incretin class catch-all, Liraglutide, Lixisenatide

Type 2 diabetes

HbA1c ≥7.5%Ph 4Completed1Sep 20203
IDEALINSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

Lixisenatide

Type 2 diabetes

Ph 4Unknown1Jan 20231
RESTORELixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2

Lixisenatide

Type 2 diabetes

BMI 25-35Ph 1Completed1Aug 2009
NCT02745470Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain

Lixisenatide

Obesity / overweight, Type 2 diabetes

BMI ≤23Not applicableCompleted1Dec 2016
NCT04893148Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Dulaglutide, Lixisenatide

Type 2 diabetes

Ph 4Unknown1Dec 2021
NCT05591391The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi

Lixisenatide

Type 2 diabetes

HbA1c ≥7%Not applicableUnknown1Jun 2025
NCT05804513The Effect of Lixisenatide on the Effect of Pituitary Hormones

Lixisenatide

Healthy volunteers, Type 1 diabetes

HbA1c ≤8.5%Ph 4Unknown1Oct 2023
NCT07307235Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents

Lixisenatide

Type 2 diabetes

HbA1c 7.5-11%Ph 4Not yet recruiting0Jun 2027
NCT02274740Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Lixisenatide

Dyslipidemia, Obesity / overweight, Type 2 diabetes

BMI ≥30Ph 2Terminated0Aug 2015
Px-LixiThe Impact of Lixisenatide on Postprandial Glucose Tolerance in Pancreatectomised Subjects

Lixisenatide

Diabetes (other / unspecified), Healthy volunteers

Healthy volunteersNot applicableCompleted0Jul 20161
NCT07173712Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes

Lixisenatide

Type 2 diabetes

BMI 20-35Ph 4Not yet recruiting0Jun 2027