Phase 1 Study to Assess How GZR18 Injection Affects Stomach Emptying and Interacts With Digoxin, Rosuvastatin, and Warfarin in Overweight or Obese Adults

What this Trial Is About

Researchers are evaluating the effects of GZR18 Injection on gastric emptying and its interactions with oral drugs digoxin, rosuvastatin calcium, and warfarin sodium in obese or overweight adults. This is a phase I, single-center, open-label study involving 60 participants with an equal gender distribution, aged 18 to 50 years, focusing on how repeated subcutaneous injections of GZR18 influence these oral medications behavior in the body. Participants receive GZR18 injections ranging from 3 mg to 36 mg over 16 weeks, alongside oral administration of warfarin sodium tablets 2.5 mg twice daily, rosuvastatin calcium tablets 10 mg twice daily, and digoxin tablets 0.25 mg twice daily. The study includes a 4-week screening period, followed by 16 weeks of single-drug administration and dose escalation, and concludes with a 6-week combined drug administration phase. Throughout the approximately 26-week participation, subjects undergo physical exams, vital signs monitoring, lab tests including blood chemistry and coagulation, ECGs, and imaging of internal organs. Researchers measure drug concentration levels in the blood and other pharmacokinetic parameters up to 16 weeks. Safety and drug interaction effects are closely monitored during and after treatment.

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