drugset / Trial / NCT07128888
Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets. A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender. The study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)
Timeline
- Start
- 2025-11-17
- Primary completion
- 2026-07-05
- Completion
- 2026-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bofanglutide | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Subject | Bofanglutide | Protein / enzyme biologic | 36 mg | Subcutaneous |
| Subject | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | Warfarin | Small molecule | 2.5 mg | Oral |