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

October 29, 2026 updated by: Beijing QL Biopharmaceutical Co.,Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400000
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Infectious Diseases Hospital & The Sixth People's Hospital of Zhengzhou
        • Contact:
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36
Maximum Concentration of ZT002 (Cmax)
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t)
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to maximum concentration (Tmax)
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36
Apparent terminal half-life (t1/2)
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36
Apparent clearance (CL/F)
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36
Incidence and severity of adverse events
Time Frame: Start of treatment up to Day 36
Start of treatment up to Day 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing QL Biopharmaceutical Co.,Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mengchang Yang, Doctor, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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