Active not recruitingPhase 1

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

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

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Asset

Zovaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 24-35•Healthy volunteers

Primary endpoints

•AUC of metformin within dosing interval (12 hours) at steady state•AUC of S-warfarin•AUC of R-warfarin

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07550816

Org study IDBJQL-ZT002-1007

Timeline

Milestones

Study first posted2026-04-24actual

Study start2026-05-27actual

Last update posted2026-10-21actual

Primary completion2026-12-05estimated

Study completion2027-03-26estimated

Assets

Investigational agents

Zovaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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.

Exclusion criteria

•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.

Exclusion criteria only applicable to Cohort 1:

•History that increases risk of bleeding, e.g. aneurysm, aortic dissection, cerebral vascular malformation, acute gastritis, gastric or duodenal ulcer; hemorrhoid bleeding within 1 month prior to screening;

•Hypersensitivity to metformin or warfarin;

•Prothrombin time (PT), international normalized ratio (INR) or activated partial thromboplastin time (APTT) above ULN and judged as clinically significant by investigator;

•Platelet < 100x109/L;

•Ventricular rate < 50 or > 100 bpm, second or third degree of atrioventricular block, left bundle branch block, complete right bundle branch block, or QT interval corrected by Fridericia's formula (QTcF) > 450 ms, or other abnormal electrocardiogram of clinical significance.

Exclusion criteria only applicable to Cohort 2:

•History of unexplained myalgia or myasthenia, or diagnosed with rhabdomyolysis;

•Hypersensitivity to rosuvastatin or digoxin;

•Unexplained creatine kinase above ULN;

•Serum potassium out of reference range;

•Ventricular rate < 55 or > 100 bpm, atrial fibrillation, atrioventricular block of any degree, preexcitation syndrome, left bundle branch block, complete right bundle branch block, or QT interval corrected by Fridericia's formula (QTcF) > 450 ms, or other abnormal electrocardiogram of clinical significance.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percentage change in body weight

Time frame:Day 13 and Day 133 in Cohort 1, Day 12 and Day 132 in Cohort 2

percent change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

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

Time frame:From Day 5 to Day 12, from Day 125 to Day 132

concentration, descriptive

Secondary/protocol endpoint

Proportion of participants with positive anti-drug antibody against ZT002

Time frame:From Day 13 to Day 167 in Cohort 1, from Day 12 to Day 166 in Cohort 2

threshold achievement, event

Secondary/protocol endpoint

Proportion of participants with treatment-emergent adverse events

Time frame:From baseline to Day 167 in Cohort 1, from baseline to Day 166 in Cohort 2

threshold achievement, event

Secondary/protocol endpoint

Proportion of participants with serious adverse events

Time frame:From baseline to Day 167 in Cohort 1, from baseline to Day 166 in Cohort 2

threshold achievement, event