Clinical Trial

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection

Recruiting Phase 1
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Record status
This record was last updated December 12, 2025 (before its estimated July 5, 2026 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-11; most recent amendment 2025-12-10.
Status change: Not Yet Recruiting → Recruiting 2025-11-20
Trial Details
NCT Number NCT07128888
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Obesity or Overweight
Enrollment 60 participants
Start Date 2025-11-17
Primary Completion 2026-07-05 (estimated)
Study Completion 2026-07-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-12