Numerous clinical trials evaluate the therapeutic profile and clinical utility of ertugliflozin in type 2 diabetes mellitus, diabetic kidney disease, hypertension, heart failure, and hepatic or renal impairment. Ranging from Early Phase 1 through Phase 4, these studies include completed, recruiting, not yet recruiting, and terminated protocols, spanning large-scale safety and efficacy evaluations to specialized physiological assessments. These trials are sponsored by pharmaceutical corporations, including Merck Sharp & Dohme LLC and Pfizer, alongside academic institutions such as Amsterdam UMC, Yonsei University, and Stanford University.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07547878 | NOT_YET_RECRUITING | Chronic Kidney Disease; Type 2 Diabetes |
Baylor Research Institute |
2026-04-30 | PHASE4 |
| NCT07621380 | NOT_YET_RECRUITING | Type 2 Diabetes Mellitus Myocardial Infarction |
Shanghai Zhongshan Hospital |
2026-07-01 | PHASE4 |
| NCT04438213 | RECRUITING | Heart Failure |
Yale University |
2021-03-10 | PHASE2 |
| NCT06983054 | RECRUITING | Type 2 Diabetes |
Amsterdam UMC, location VUmc |
2023-07-25 | PHASE4 |
| NCT05727579 | COMPLETED | Diabetes Mellitus; Diabetic Kidney Disease; Hypertension |
Amsterdam UMC, location VUmc |
2023-07-03 | PHASE4 |
| NCT05644717 | RECRUITING | Liver Fat; Liver Fibrosis; Glycemic Control; Body Weight Changes; Waist Circumference; Tolerance |
Getz Pharma |
2023-03-01 | PHASE4 |
| NCT07266779 | COMPLETED | Type 2 Diabetes |
Humanis Saglık Anonim Sirketi |
2025-08-22 | PHASE1 |
| NCT04029480 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2019-10-08 | PHASE3 |
| NCT04167761 | COMPLETED | Cardiovascular Diseases; Atherosclerosis; Type 2 Diabetes; Insulin Resistance |
Stanford University |
2020-07-01 | EARLY_PHASE1 |
| NCT04231331 | COMPLETED | Mitral Valve Insufficiency; Left Ventricular Systolic Dysfunction |
Asan Medical Center |
2020-11-04 | PHASE3 |
| NCT05152940 | COMPLETED | Heart Failure With Reduced Ejection Fraction; Congestion |
Icahn School of Medicine at Mount Sinai |
2023-02-02 | PHASE4 |
| NCT04600921 | TERMINATED | Heart Failure With Reduced Ejection Fraction; Heart Failure With Mid Range Ejection Fraction; Implantable Cardioverter-Defibrillators; Cardiac Resynchronization Therapy |
Medical University of Graz |
2021-06-24 | PHASE3 |
| NCT05727579 | Not yet recruiting | Diabetes Mellitus|Diabetic Kidney Disease|Hypertension |
Amsterdam UMC location VUmc|Merck Sharp & Dohme LLC|University of Colorado Denver |
2023-06-01 | Phase 4 |
| NCT04071626 | TERMINATED | Heart Failure, Diastolic; Diabetes Mellitus, Type 2 |
University Hospitals Cleveland Medical Center |
2020-03-01 | PHASE4 |
| NCT04027530 | COMPLETED | Type 2 Diabetes Mellitus; Diabetic Kidney Disease; Diabetic Nephropathy; Renal Hypoxia; Renoprotection; SGLT2 Inhibitor; Ertugliflozin |
Amsterdam UMC, location VUmc |
2020-12-10 | PHASE4 |
| NCT03717194 | COMPLETED | Type2 Diabetes; Heart Failure |
Soo Lim |
2019-06-01 | PHASE3 |
| NCT04490681 | UNKNOWN | Heart Failure With Nonischemic Cardiomyopathy |
Yonsei University |
2020-08 | PHASE3 |
| NCT03416270 | COMPLETED | Type 2 Diabetes Mellitus; Heart Failure |
University Health Network, Toronto |
2018-06-28 | PHASE2 |
| NCT04490681 | Unknown status | Heart Failure With Nonischemic Cardiomyopathy |
Yonsei University |
2020-08 | Phase 3 |
| NCT03640221 | WITHDRAWN | Hypertension; Diabetes Mellitus, Type 2 |
Cedars-Sinai Medical Center |
2018-09-01 | PHASE4 |
| NCT01986881 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-11-04 | PHASE3 |
| NCT02630706 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2015-12-16 | PHASE3 |
| NCT02033889 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-12-13 | PHASE3 |
| NCT01999218 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-12-16 | PHASE3 |
| NCT01986855 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-12-02 | PHASE3 |
| NCT01958671 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-10-09 | PHASE3 |
| NCT02036515 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-03-12 | PHASE3 |
| NCT02099110 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-04-22 | PHASE3 |
| NCT02226003 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-09-23 | PHASE3 |
| NCT02411929 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-10-29 | PHASE1 |
| NCT02115347 | COMPLETED | Type 2 Diabetes Mellitus; Hepatic Impairment |
Merck Sharp & Dohme LLC |
2014-09-19 | PHASE1 |
| NCT01948986 | COMPLETED | Renal Impairment; Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-10-01 | PHASE1 |
| NCT02115347 | Completed | Type 2 Diabetes Mellitus|Hepatic Impairment |
Merck Sharp & Dohme LLC|Pfizer |
2014-09-19 | Phase 1 |
| NCT01096667 | COMPLETED | Diabetes Mellitus, Type 2; Hypertension |
Merck Sharp & Dohme LLC |
2010-05-17 | PHASE2 |
| NCT01223339 | COMPLETED | Diabetes Mellitus, Type 2 |
Merck Sharp & Dohme LLC |
2010-10 | PHASE1 |
| NCT01059825 | COMPLETED | Diabetes Mellitus, Type 2 |
Merck Sharp & Dohme LLC |
2010-02-24 | PHASE2 |
| NCT01127308 | COMPLETED | Type 2 Diabetes Mellitus (T2DM) |
Merck Sharp & Dohme LLC |
2010-06 | PHASE1 |
| NCT01114568 | COMPLETED | Healthy |
Merck Sharp & Dohme LLC |
2010-05 | PHASE1 |
| NCT01054300 | COMPLETED | Diabetes Mellitus, Type 2; Adult |
Merck Sharp & Dohme LLC |
2010-02-17 | PHASE1 |
| NCT01018823 | COMPLETED | Healthy Volunteer |
Merck Sharp & Dohme LLC |
2009-12-14 | PHASE1 |
| NCT00989079 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2009-10-16 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-08)
Check the
Ertugliflozin
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.