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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  3. Eligibility criteria expanded, about 27 words Secondary endpoints: details revised at 5 of 5 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 5 of 5 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT07128888
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Obesity or Overweight
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov