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

This study is a single-dose, open-label, non-randomized, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with varying degrees of Hepatic Impairment and matched participants with normal hepatic function.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight, Obesity
• Intervention / Treatment: Drug: Zovaglutide; Drug: Zovaglutide

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Donglei Wang; Phone Number: +8613932155055; Email: wang.donglei@qlbiopharm.com
• Study Contact Backup: Name: Kun Guan; Phone Number: +8615040353238; Email: guan.kun@qlbiopharm.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400000
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Xian Yu, Doctor; Phone Number: 18512356862; Email: 22168398@qq.com
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Infectious Diseases Hospital & The Sixth People's Hospital of Zhengzhou
      • Contact: Shuang Li, Master; Phone Number: 13938529645; Email: li36918@163.com
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
      • Contact: Mengchang Yang, Doctor; Phone Number: 18140049936; Email: ymc681@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Mild Hepatic Impairment)	Drug: Zovaglutide; All subjects will be treated with a single subcutaneous injection of Zovaglutide; Drug: Zovaglutide; All subjects will be treated with a single subcutaneous injection of Zovaglutide.
Experimental: Group B (Moderate Hepatic Impairment)	Drug: Zovaglutide; All subjects will be treated with a single subcutaneous injection of Zovaglutide; Drug: Zovaglutide; All subjects will be treated with a single subcutaneous injection of Zovaglutide.
Experimental: Group C (Normal hepatic function)	Drug: Zovaglutide; All subjects will be treated with a single subcutaneous injection of Zovaglutide; Drug: Zovaglutide; All subjects will be treated with a single subcutaneous injection of Zovaglutide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)	Start of treatment up to Day 36
Maximum Concentration of ZT002 (Cmax)	Start of treatment up to Day 36
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t)	Start of treatment up to Day 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximum concentration (Tmax)	Start of treatment up to Day 36
Apparent terminal half-life (t1/2)	Start of treatment up to Day 36
Apparent clearance (CL/F)	Start of treatment up to Day 36
Incidence and severity of adverse events	Start of treatment up to Day 36

Collaborators and Investigators

• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd
• Investigators: Principal Investigator: Mengchang Yang, Doctor, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 13, 2026
• Primary Completion (Estimated): June 19, 2027
• Study Completion (Estimated): September 25, 2027

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: BJQL-ZT002-1009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No