Not yet recruitingPhase 1

A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants

A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single Dose of Zovaglutide (ZT002 Injection) in Participants With Varying Degrees of Hepatic Impairment and Matched Participants With Normal Hepatic Function

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 18-32

Primary endpoints

•AUC of ZT002•Cmax of ZT002(Cmax)

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 IDNCT07916194

Org study IDBJQL-ZT002-1009

Timeline

Milestones

Study first posted2026-11-04actual

Last update posted2026-11-04actual

Study start2026-11-13estimated

Primary completion2027-06-19estimated

Study completion2027-09-25estimated

Assets

Investigational agents

Zovaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

All participants:

•Male or female subjects aged≥18 years and≤75 years (both inclusive) at the time of signing the Informed Consent Form (ICF).

•Body Mass Index (Body mass index (BMI) 18.0 - 32.0 kg/m² (both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.

•Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent.

Participants with Hepatic Impairment:

• Participants with chronic mild and moderate hepatic impairment, assessed by Child-Pugh scoring

Exclusion criteria

All participants:

•History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.

•Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).or any GI disease which impacts gastric emptying

•Have a history of severe GI disease within 6 months before screening , or have received GI surgery (appendectomy, cholecystectomy are excepted), or clinically significant gastric emptying disorders.

•Medical history of hypoglycemia within 6 months before screening;

•eGFR<60 mL/min/1.73m²

Participants with Hepatic Impairment:

•Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;

•Have a severe portal shunt or prior portosystemic shunt within 3 months before screening;

•Severe ascites and/or pleural effusion requiring paracentesis;

•Have other causes of hepatic injury unrelated to hepatic parenchymal disease and/or cholestatic liver disease at screening;.

•History of acute liver failure, esophagogastric variceal bleeding within 6 months before screening;

•History of Hepatic encephalopathy of Grade 3 or 4.

•Have hemoglobin <70 grams per deciliter (g/L)

•Have platelet <50×10^9/L

•HbA1c ≥ 8.0% or fasting blood glucose ≥ 11.10 mmol/L at screening.

Endpoints (7)

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.