A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants

April 15, 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 Different Degrees of Renal Insufficiency and Matched Participants With Normal Renal Function

This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • The First Affiliated Hospital Of Shandong First Medical Unversity
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 250014
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
  2. Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
  3. Body mass index (BMI) 19.0 - 32.0 kg/m²(both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
  4. Diagnosed as stable, chronic renal disease for at least 3 months.

  5. Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):

    Normal renal function: 90-129 mL/min (inclusive); Mild impairment: 60-89 mL/min (inclusive); Moderate impairment: 30-59 mL/min (inclusive); Severe impairment: 15-29 mL/min (inclusive);

  6. Stable renal function, assessed by two eGFR during screening.

Exclusion Criteria:

  • All participants will not be included in this study if they meet any of the following criteria:

    1. History of acute or chronic pancreatitis, or pancreatic injury.
    2. History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
    3. History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
    4. Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin)

    5. 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).

      Participants in the renal insufficiency group will not be included in this study if they meet any of the following criteria:

    6. Those with obstructive uropathy (e.g., urinary tract obstruction due to calculi or space-occupying lesions) or renal impairment caused by other etiologies unrelated to intrinsic renal dysfunction (e.g., renal tumors) and/or renal diseases (e.g., renal artery stenosis, nephrotoxic drugs, severe infections, hypovolemia, heart failure, etc.), and deemed by the investigator as unsuitable for participation in this clinical trial.
    7. Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;

    8. Those who have received any medications known to alter renal tubular creatinine secretion (e.g., cimetidine, trimethoprim, or cibenzoline, or salicylates excluding topical formulations), competitive inhibitors of renal tubular secretion (e.g., probenecid), or nephrotoxic drugs (e.g., non-steroidal anti-inflammatory drugs, polymyxins, vancomycin) within 14 days prior to screening or 5 half-lives (whichever is longer).

      Participants in the normal renal function group will not be included in this study if they meet any of the following criteria:

    9. Those who have suffered from diseases of other systems, such as the cardiovascular, respiratory, digestive, endocrine, hematologic, or neuropsychiatric systems, within 1 year prior to screening, and are considered by the investigator to be unsuitable for participation in this study.
    10. Those with systolic blood pressure exceeding 90-140 mmHg (including both end values) or diastolic blood pressure exceeding 50-90 mmHg (including both end values)
    11. Use of any medication, including prescription drugs, over-the-counter medication, Chinese herbal medicines, and dietary supplements (e.g., vitamins and minerals that may affect study outcomes) within 14 days or 5 half-lives (whichever is longer) prior to 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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group (Mild Renal Impairment)
Drug: Zovaglutide
Receive a single dose , SC
Other Names:
  • ZT002 Injection
Experimental: B group (Moderate Renal Impairment)
Drug: Zovaglutide
Receive a single dose , SC
Other Names:
  • ZT002 Injection
Experimental: C group (Severe Renal Impairment)
Drug: Zovaglutide
Receive a single dose , SC
Other Names:
  • ZT002 Injection
Experimental: D group (Healthy Control)
Drug: Zovaglutide
Receive a single dose , SC
Other Names:
  • ZT002 Injection

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 Tlast (AUC0-t).
Time Frame: Start of Treatment up to Day 50
Start of Treatment up to Day 50
Maximum Concentration of ZT002 (Cmax)
Time Frame: Start of Treatment up to Day 50
Start of Treatment up to Day 50
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
Time Frame: Start of Treatment up to Day 50
Start of Treatment up to Day 50
Time to maximum concentration (Tmax)
Time Frame: From baseline to Day 50
From baseline to Day 50
Apparent terminal half-life (t1/2)
Time Frame: From baseline to Day 50
From baseline to Day 50
Apparent clearance (CL/F)
Time Frame: From baseline to Day 50
From baseline to Day 50
Incidence and severity of adverse events
Time Frame: Screening period up to Day 50
Screening period up to Day 50

Collaborators and Investigators

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

Sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Investigators

  • Principal Investigator: Wei Zhao, PhD, The First Affiliated of Shandong First Medical University

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 (Actual)

April 13, 2026

Primary Completion (Estimated)

December 3, 2026

Study Completion (Estimated)

March 19, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJQL-ZT002-1006

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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