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

NCT07550816 | Not Yet Recruiting Phase 1

• 1 other identifier: BJQL-ZT002-1007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight,Obesity

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (11)

• Maximal observed concentration of metformin at steady state

  From Day 4 to Day 5, from Day 112 to Day 113

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

  From Day 6 to Day 13, from Day 126 to Day 133

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

  From Day 6 to Day 13, from Day 126 to Day 133

• Maximal observed concentration of rosuvastatin after single-dose administration

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

• Maximal observed concentration of digoxin after single-dose administration

  From Day 5 to Day 12, from Day 125 to Day 132

Study Arms (2)

cohort1

EXPERIMENTAL

ZT002 injection, metformin, warfarin

Drug: ZT002 injection, metformin, warfarin

cohort2

EXPERIMENTAL

ZT002 injection, rosuvastatin, digoxin

Drug: ZT002 injection, rosuvastatin, digoxin

Interventions

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

cohort1

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

cohort2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Medical history of hypoglycemia within 6 months before screening;
• History of acute or chronic pancreatitis;
• Cholelithiasis ≤ 1 cm, or history of cholecystitis or other symptomatic gallbladder disease, with the exception of cholecystectomy \> 6 months prior to screening;
• History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
• Glycated hemoglobin (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening;
• Aspartate aminotransferase ≥ 2 × upper limit of normal (ULN), Alanine aminotransferase ≥ 2 × ULN,
• Alkaline phosphatase total bilirubin ≥ 1.5 × ULN;
• Calcitonin above ULN at screening;
• Thyroid stimulating hormone (TSH) \< 0.4 or \>6.0 mIU/L;
• Use of hypoglycemic drugs (e.g. insulin, insulin secretagogues, thiazolidinedione, sodium-dependent glucose transporters 2 inhibitors \[SGLT2i\], dipeptidyl peptidase 4 inhibitor \[DPP-4i\], glucagon-like peptide-1 receptor agonist \[GLP-1RA\], metformin, α-glucosidase inhibitor) within 3 months before screening;
• Use of prescription drugs, over-the-counter drugs, dietary supplements, vitamins, or herbal medicines (excluding topical eye/nose drops and external use on the skin without systemic exposure risk) within 2 weeks before screening.

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd: lead

Study Sites (1)

West China Second Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Metformin; Warfarin; Rosuvastatin Calcium; Digoxin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Qin Yu, Master

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei Liu

CONTACT

+86-18810808386; liu.pei@qlbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): March 26, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)