ZT002 Injection Phase 1 Drug-Drug Interaction Study in Overweight Participants
Summary
A Phase 1 open-label, fixed-sequence, two-period crossover drug-drug interaction study (NCT07550816) evaluating ZT002 injection, an ultralong-acting glucagon-like peptide-1, in obese and overweight but otherwise healthy participants aged 18-45. Cohort 1 assesses ZT002 impact on steady-state metformin PK and single-dose warfarin PK; Cohort 2 evaluates ZT002 impact on single doses of rosuvastatin and digoxin. Participants in each cohort receive drugs without ZT002 in Period 1, then with ZT002 (up-titrated to steady state) in Period 2, followed by 6-week follow-up.
“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.”
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What changed
This ClinicalTrials.gov registry entry documents a Phase 1 drug-drug interaction study of ZT002 injection, an ultralong-acting GLP-1, in overweight and obese but otherwise healthy adults aged 18-45. The two-cohort, fixed-sequence, two-period crossover design evaluates ZT002's impact on the pharmacokinetics of four common medications: metformin (steady state), warfarin (single dose), rosuvastatin (single dose), and digoxin (single dose). Each participant undergoes screening, receives study drugs without ZT002 in Period 1, then receives study drugs with up-titrated ZT002 in Period 2, followed by 6-week follow-up.
Affected parties include clinical investigators conducting early-phase obesity and metabolic research, pharmaceutical companies developing GLP-1-based therapies, and institutional review boards overseeing study protocols. The study provides foundational PK interaction data that may inform future labeling, prescribing guidance, or contraindication updates for ZT002 if it advances to later-stage trials or approval.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Drug-drug Interaction Study of ZT002 Injection in Overweight and Obese Participants
Phase 1 NCT07550816 Kind: PHASE1 Apr 24, 2026
Abstract
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 a...
Conditions: Overweight,Obesity
Interventions: ZT002 injection, metformin, warfarin, ZT002 injection, rosuvastatin, digoxin
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