NCT07128888

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

A Study to Evaluate the Effect of GZR18 Injection on Gastric Emptying and Its Drug-Drug Interactions With Digoxin, Rosuvastatin Calcium and Warfarin Sodium in Obese or Overweight Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets	GZR18 injection: 3 mg-36 mg，16 weeks; Warfarin Sodium Tablets:2.5mg，twice; Rosuvastatin Calcium Tablets：10mg，twice; Digoxin Tablets:0.25mg，twice

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-07-05
• Completion: 2026-07-05
• First posted: 2025-08-19
• Last updated: 2025-12-12

Locations

1 site across 1 country: China