Lixisenatide has been evaluated in numerous Phase 1 through Phase 4 clinical trials, primarily targeting Type 2 Diabetes Mellitus alongside Type 1 Diabetes, steroid-induced hyperglycemia, and Parkinson disease. Sponsored by pharmaceutical entities like Sanofi and academic institutions such as the University of Tartu and Toulouse University Hospital, these studies encompass completed, actively recruiting, terminated, and prospective protocols. Collectively, these evaluations assess the metabolic impacts, glycemic control, and safety profile of lixisenatide across diverse patient populations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07117240 | ENROLLING_BY_INVITATION | Steroid-Induced Diabetes; Steroid-Induced Hyperglycemia; Diabetes |
Medical University of Warsaw |
2025-07-10 | PHASE4 |
| NCT07307235 | RECRUITING | Type 2 Diabetes |
Shanghai Zhongshan Hospital |
2025-12-13 | PHASE4 |
| NCT07173712 | NOT_YET_RECRUITING | Type 2 Diabetes |
Yanbing Li |
2026-03-15 | PHASE4 |
| NCT06671587 | RECRUITING | Type 2 Diabetes (T2D) |
Sanofi |
2024-12-10 | PHASE4 |
| NCT06716424 | COMPLETED | Type 2 Diabetes |
Sanofi |
2025-01-06 | PHASE4 |
| NCT05804513 | UNKNOWN | Healthy; Type 1 Diabetes |
University of Tartu |
2023-04-17 | PHASE4 |
| NCT05413369 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2022-07-07 | PHASE3 |
| NCT05114590 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2022-01-27 | PHASE4 |
| NCT03439943 | COMPLETED | Parkinson Disease |
University Hospital, Toulouse |
2018-06-13 | PHASE2 |
| NCT03798054 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2019-02-15 | PHASE3 |
| NCT03798080 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2019-02-19 | PHASE3 |
| NCT03767543 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2019-03-11 | PHASE3 |
| NCT03881995 | TERMINATED | Diabetes Mellitus, Type 2 |
University Hospital Tuebingen |
2019-03-18 | PHASE4 |
| NCT02803918 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2017-05-17 | PHASE1 |
| NCT03529123 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2018-06-19 | PHASE3 |
| NCT03819790 | COMPLETED | Diabetes Mellitus, Type 2 |
LMC Diabetes & Endocrinology Ltd. |
2018-10-02 | PHASE4 |
| NCT03434119 | TERMINATED | Type 2 Diabetes Mellitus |
Sanofi |
2018-02-20 | PHASE3 |
| NCT02752412 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2016-05-17 | PHASE3 |
| NCT02231658 | TERMINATED | Diabetes Mellitus |
Profil Institut für Stoffwechselforschung GmbH |
2015-07-16 | PHASE1 |
| NCT02787551 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2016-07-06 | PHASE3 |
| NCT02749890 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2016-05-09 | PHASE3 |
| NCT02752828 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2016-05-23 | PHASE3 |
| NCT02941367 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2017-02-23 | PHASE4 |
| NCT02767596 | TERMINATED | Diabetes Mellitus Type 2 |
Laniado Hospital |
2016-07-12 | PHASE4 |
| NCT02745470 | COMPLETED | Diabetes Mellitus |
Seoul National University Hospital |
2016-02 | |
| NCT02640118 | COMPLETED | Diabetes After Total Pancreatectomy |
University Hospital, Gentofte, Copenhagen |
2015-08 | |
| NCT02713477 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2016-04 | PHASE1 |
| NCT02276196 | COMPLETED | Diabetic Kidney Disease; Diabetic Nephropathy; Diabetes Mellitus; Glucagon-Like Peptide 1 |
Amsterdam UMC, location VUmc |
2014-09 | PHASE4 |
| NCT02308254 | UNKNOWN | Diabetes Mellitus; Gastroparesis |
Royal Adelaide Hospital |
2013-11 | PHASE1; PHASE2 |
| NCT02049034 | COMPLETED | Type 2 Diabetes |
University of Surrey |
2014-01 | PHASE4 |
| NCT02200991 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2014-08 | PHASE4 |
| NCT02274740 | TERMINATED | Type II Diabetes Mellitus |
Sanofi |
2015-04 | PHASE2 |
| NCT02168491 | COMPLETED | Type 2 Diabetes Mellitus |
Medical University of Vienna |
2014-11 | PHASE3 |
| NCT02058160 | COMPLETED | Type 2 Diabetes |
Sanofi |
2014-01 | PHASE3 |
| NCT01940965 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2013-09 | PHASE3 |
| NCT02058147 | COMPLETED | Type 2 Diabetes |
Sanofi |
2014-02 | PHASE3 |
| NCT01632163 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2012-10 | PHASE3 |
| NCT02274740 | Terminated | Type II Diabetes Mellitus |
Sanofi |
2015-04 | Phase 2 |
| NCT01960179 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2013-11 | PHASE3 |
| NCT01147250 | COMPLETED | Acute Coronary Syndrome |
Sanofi |
2010-06 | PHASE3 |
| NCT01798706 | COMPLETED | Type 2 Diabetes |
Sanofi |
2013-06 | PHASE3 |
| NCT01768559 | COMPLETED | Type 2 Diabetes |
Sanofi |
2013-01 | PHASE3 |
| NCT01973231 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2013-10 | PHASE4 |
| NCT01910194 | COMPLETED | Diabetes Mellitus |
Profil Institut für Stoffwechselforschung GmbH |
2013-12 | PHASE2 |
| NCT02020629 | COMPLETED | Type 2 Diabetes |
Lund University |
2013-12 | PHASE4 |
| NCT01572649 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2012-05 | PHASE1 |
| NCT01596504 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2012-05 | PHASE2 |
| NCT01517412 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2012-02 | PHASE3 |
| NCT01476475 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2011-11 | PHASE2 |
| NCT01169779 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2010-07 | PHASE3 |
| NCT00975286 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2009-10 | PHASE3 |
| NCT00763815 | COMPLETED | Diabetes Mellitus Type 2 |
Sanofi |
2008-09 | PHASE3 |
| NCT00976937 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2009-08 | PHASE3 |
| NCT00712673 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2008-06 | PHASE3 |
| NCT00715624 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2008-07 | PHASE3 |
| NCT00763451 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2008-09 | PHASE3 |
| NCT00713830 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2008-07 | PHASE3 |
| NCT00905255 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2009-05 | PHASE3 |
| NCT00707031 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2008-06 | PHASE3 |
| NCT01175473 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2010-08 | PHASE2 |
| NCT01146678 | COMPLETED | Type 1 Diabetes Mellitus |
Sanofi |
2010-06 | PHASE1 |
| NCT00866658 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2009-03 | PHASE3 |
| NCT00688701 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2008-05 | PHASE3 |
| NCT00931372 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2009-06 | PHASE1 |
| NCT00299871 | COMPLETED | Type 2 Diabetes |
Sanofi |
2006-02 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-09-19)
Check the
Lixisenatide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.