drugset / Trial / NCT03861039
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
Timeline
- Start
- 2019-03-30
- Primary completion
- 2021-01-26
- Completion
- 2021-02-16
Publications
- Mimura H, Oura T, Chin R, Hirase T, Shimono D. Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Diabetes Ther. 2025 Sep;16(9):1871-1885. doi: 10.1007/s13300-025-01775-y. Epub 2025 Jul 25.
- Kadowaki T, Chin R, Ozeki A, Imaoka T, Ogawa Y. Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):634-644. doi: 10.1016/S2213-8587(22)00187-5. Epub 2022 Jul 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirzepatide | Peptide | 5 mg | — |
| Subject | Tirzepatide | Peptide | 10 mg | — |
| Subject | Tirzepatide | Peptide | 15 mg | — |