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Drug-drug Interaction Study of ZT002 Injection in Overweight and Obese Participants

ConditionOverweight,Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing QL Biopharmaceutical Co.,Ltd

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 - 45 years (both inclusive) at the time of signing of the informed consent;

Male (body weight >60.0 kg) or female (body weight >55.0 kg). Body mass index (BMI) 24.0 - 35.0 kg/m²(both inclusive);

Considered to be generally healthy based on physical examination, and the results of vital signs, 12-lead electrocardiogram and clinical laboratory tests (hematology, urinalysis, chemistry, coagulation), as judged by the investigator.

Disqualifiers

Clinically significant diseases detected within 6 months before screening (including but not limited to neurological, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, hematological, immunological diseases), judged by the investigator as possible to influence the study result or introduce safety risk to study drug administration;

History of dysphagia or any gastrointestinal tract disease that affects drug absorption;

Known hypersensitivity (asthma, hypersensitivity to GLP-1 receptor agonists or excipients), or known hypersensitivity to ZT002 injection;

History of inspirational pneumonia within 5 years before screening;

Trial design

Design model

Crossover

Treatments tested in this trial

  • ZT002 injection, metformin, warfarin

    Drug

    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

  • ZT002 injection, rosuvastatin, digoxin

    Drug

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: cohort1Experimental treatment 1 intervention
Group B: cohort2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under the concentration-time curve of metformin within dosing interval (12 hours) at steady state

Time frame
From Day 4 to Day 5, from Day 112 to Day 113
2

Area under the concentration-time curve of S-warfarin from time zero to infinity after single-dose administration

Time frame
From Day 6 to Day 13, from Day 126 to Day 133
3

Area under the concentration-time curve of R-warfarin from time zero to infinity after single-dose administration

Time frame
From Day 6 to Day 13, from Day 126 to Day 133
4

Area under the concentration-time curve of rosuvastatin from time zero to infinity after single-dose administration

Time frame
From Day 1 to Day 5, from Day 111 to Day 115

Secondary outcomes

1

Maximal observed concentration of metformin at steady state

Time frame
From Day 4 to Day 5, from Day 112 to Day 113
2

Maximal observed concentration of S-warfarin after single-dose administration

Time frame
From Day 6 to Day 13, from Day 126 to Day 133
3

Maximal observed concentration of R-warfarin after single-dose administration

Time frame
From Day 6 to Day 13, from Day 126 to Day 133
4

Maximal observed concentration of rosuvastatin after single-dose administration

Time frame
From Day 1 to Day 5, from Day 111 to Day 115

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing QL Biopharmaceutical Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
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