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

Registration

Registration

NCT07550816

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

RECRUITING

Enrollment

60

Start

2026-05-27

Primary completion

2026-12-05

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Conditions

Overweight,Obesity

Interventions

DRUG:ZT002 injection, metformin, warfarin; DRUG:ZT002 injection, rosuvastatin, digoxin

Results posted

FALSE

Registered primary outcomes

• 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]