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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 21, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07550816). This is a study registration, not published results. Lead sponsor: Beijing QL Biopharmaceutical Co.,Ltd. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Overweight,Obesity. Interventions: DRUG: ZT002 injection, metformin, warfarin; DRUG: ZT002 injection, rosuvastatin, digoxin. Primary outcome measures: Area under the concentration-time curve of metformin within dosing interval (12 hours) at steady state , From Day 4 to Day 5, from Day 112 to Day 113; Area under the concentration-time curve of S-warfarin from time zero to infinity after single-dose administration , From Day 6 to Day 13, from Day 126 to Day 133; Area under the concentration-time curve of R-warfarin from time zero to infinity after single-dose administration , From Day 6 to Day 13, from Day 126 to Day 133; Area under the concentration-time curve of rosuvastatin from time zero to infinity after single-dose administration , From Day 1 to Day 5, from Day 111 to Day 115; Area under the concentration-time curve of digoxin from time zero to infinity after single-dose administration , From Day 5 to Day 12, from Day 125 to Day 132. Brief 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.