Drug-drug Interaction Study of ZT002 Injection in Overweight and Obese Participants
A Drug-drug Interaction Study to Evaluate the Impact of Multiple Subcutaneous Injections of ZT002 on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin and Digoxin in Overweight and Obese Participants
Beijing QL Biopharmaceutical Co.,Ltd
60 participants
May 27, 2026
INTERVENTIONAL
Conditions
Summary
ZT002 is an ultralong-acting glucagon-like peptide-1. This open-label, fixed sequence, two-period crossover drug-drug interaction study is designed to evaluate the impact of ZT002 on the PK of metformin, warfarin, rosuvastatin and digoxin. The study will include obese and overweight but otherwise healthy participants aged 18 - 45. The study consists of two cohorts. Each participant can only join one of the cohorts. Cohort 1 evaluates the impact of ZT002 on the PK of metformin at steady state and on the PK of a single dose of warfarin. Participants are screened within 2 weeks before study drug administration. In the first period, metformin is given twice daily for 3.5 days and warfarin is given as a single dose without ZT002. In the second period, metformin and warfarin are given, following the same dose and regimen as in the first period, concomitantly with ZT002, which reaches steady state by up-titration. The participants will be followed up for 6 weeks after the last dose of ZT002. Cohort 2 evaluates the impact of ZT002 on the PK of single doses of rosuvastatin and digoxin. Participants are screened within 2 weeks before study drug administration. In the first period, rosuvastatin and digoxin are given as single doses without ZT002. In the second period, rosuvastatin and digoxin are given, following the same dose and regimen as in the first period, concomitantly with ZT002, which reaches steady state by up-titration. The participants will be followed up for 6 weeks after the last dose of ZT002.
Eligibility
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Interventions
Drug: metformin Participants will receive metformin twice daily for 3.5 days in both periods Drug: warfarin Participants will receive a single dose of warfarin in both periods Drug: ZT002 Participants will receive multiple doses of ZT002 in the second period
Drug: rosuvastatin Participants will receive a single dose of rosuvastatin in both periods Drug: digoxin Participants will receive a single dose of digoxin in both periods Drug: ZT002 Participants will receive multiple doses of ZT002 in the second period
Locations(1)
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NCT07550816