Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Hanmi Pharmaceutical Company Limited · Type 2 Diabetes Mellitus
Phase 3
Completed
406
2022-01
Evidence dashboardStudies since 2017Updated Jul 31, 2026
EfpeglenatideClinical Trials.
A source-linked view of every Efpeglenatide study in the current snapshot—status, phase, enrollment, results, publications, locations and changes over time.
- Total trials
- 5
- Recruiting
- 0
- Completed
- 1
- Terminated
- 4
- Results posted
- 5
- Average enrollment
- 1,214
- Countries
- 31
- Highest phase
- Phase 3
Largest indexed study
4,076 participants · NCT03496298 →Developer / research origin
Hanmi Pharmaceutical / Sanofi
Evidence summary
Activity is not efficacy.
Efpeglenatide appears in 5 indexed studies: 0 recruiting, 1 completed and 5 with registry results posted. The highest registered development stage in this snapshot is Phase 3. These counts measure registry activity; they do not establish that Efpeglenatide is safe or effective.
Review the design, endpoints, population, protocol changes, statistical analysis and publications before drawing conclusions.
Current studies
Recruiting or active
Completed studies
Finished records
Stopped studies
Withdrawn or terminated
No studies in this snapshot.
NCT IDStudyPhase / statusEnrollmentUpdated
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Terminated
370
2021-12
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Terminated
312
2021-12
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Terminated
908
2021-11
Effect of Efpeglenatide on Cardiovascular Outcomes
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Terminated
4,076
2021-10
Full study index
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Add status, phase, condition, country, result and publication filters inside this molecule’s indexed study set.
5 matching studies
Last registry update first
Latest publications
Follow the paper trail.
PMID 35671039 ↗Frias JP, Choi J, Rosenstock J, Popescu L, Niemoeller E, Muehlen-Bartmer I, Baek S. Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1592-1600. doi: 10.2337/dc21-2656.Linked from NCT03353350PMID 34215025 ↗Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K; AMPLITUDE-O Trial Investigators. Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28.Linked from NCT03496298PMID 39963952 ↗Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.Linked from NCT03496298PMID 36802715 ↗Gerstein HC, Li Z, Ramasundarahettige C, Baek S, Branch KRH, Del Prato S, Lam CSP, Lopes RD, Pratley R, Rosenstock J, Sattar N. Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial. Circulation. 2023 Mar 28;147(13):1004-1013. doi: 10.1161/CIRCULATIONAHA.122.063716. Epub 2023 Feb 20.Linked from NCT03496298PMID 34775781 ↗Lam CSP, Ramasundarahettige C, Branch KRH, Sattar N, Rosenstock J, Pratley R, Del Prato S, Lopes RD, Niemoeller E, Khurmi NS, Baek S, Gerstein HC. Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial. Circulation. 2022 Feb 22;145(8):565-574. doi: 10.1161/CIRCULATIONAHA.121.057934. Epub 2021 Nov 14.Linked from NCT03496298PMID 33026143 ↗Gerstein HC, Branch K, Heenan L, Del Prato S, Khurmi NS, Lam CSP, Pratley R, Rosenstock J, Sattar N. Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist. Diabetes Obes Metab. 2021 Feb;23(2):318-323. doi: 10.1111/dom.14223. Epub 2020 Oct 22.Linked from NCT03496298
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Commercial research listings, where present, are kept separate from clinical evidence and are not treatment recommendations.