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Subcutaneous · GLP-1 agonist

Lixisenatide

79 trials in this molecule. Source: ClinicalTrials.gov, as of July 6, 2026.

Trials

79

Ongoing

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.

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

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

Programs for this asset

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

79 of 79

GLP-1 and incretin trials
Asset / PopulationEligibility highlightEvidence
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 2011-results
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 2019-results
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 2023-results
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

Showing 1-25 of 79 trials