drugset / Trial / NCT04345107
Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus
RandomizedSequentialDouble-blindTreatment
Summary
This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SY-009 after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).
Timeline
- Start
- 2020-05-01
- Primary completion
- 2021-04-29
- Completion
- 2021-09-21
Publications
- Yang H, Zhang Y, Hong Y, Wei Y, Zhu Y, Huang L, Yang Y, Sun R, Li J. Effect of SY009, a novel SGLT1 inhibitor, on the plasma metabolome and bile acids in patients with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2025 Jan 28;16:1487058. doi: 10.3389/fendo.2025.1487058. eCollection 2025.
- Huang L, Cao B, Geng Y, Zhou X, Yang Y, Ma T, Lin H, Huang Z, Zhuo L, Li J. A randomized double-blind phase Ib clinical trial of SY-009 in patients with type 2 diabetes mellitus. Eur J Pharm Sci. 2024 Jan 1;192:106644. doi: 10.1016/j.ejps.2023.106644. Epub 2023 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SY-009 | Unknown | 1 mg | Oral |
| Subject | SY-009 | Unknown | 2 mg | Oral |
| Subject | SY-009 | Unknown | 3 mg | Oral |
| Subject | SY-009 | Unknown | 4 mg | Oral |