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RecruitingPhase 1

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

24

estimated

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

BMI 19-32

Primary endpoints

CmaxAUC at 0 h to last observation time-point after a single doseAUC at 0 h to infinity after a single dose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07144098
Org study IDGZR18-BWM-107

Timeline

Milestones

Study start2025-08-12actual
Study first posted2025-08-27actual
Last update posted2025-08-27actual
Primary completion2026-07-12estimated
Study completion2027-01-26estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

All Subjects:

1. Subjects who fully understand the study contents, study procedures and possible risks, can follow the contraindications and restrictions specified in this protocol, and voluntarily sign the informed consent form.

2. Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing the ICF.

3. Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 19.0-32.0 kg/m2 (both inclusive).

4. Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation or egg donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening.

Only for Subjects with Liver Dysfunction:

5. Chronic liver insufficiency caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis or other reasons, and after comprehensive assessment by researchers, the disease is not in the rapid progression stage.

6. Determined as grade A, B or C according to the Child-Pugh score, and no albumin was used within 21 days before screening.

7. Researchers determine the physical condition of those who are eligible for this test based on medical history inquiry, physical examination, vital signs, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.), 12-lead electrocardiogram, chest X-ray, B-ultrasound, etc.

Only for Subjects with Normal Liver Function:

1. Matched with the subjects in the liver insufficiency group in terms of mean age (±10 years), sex ±1, mean weight (±10 kg), and mean BMI (±20%).

2. Those whose clinical laboratory tests, vital signs, physical examinations, electrocardiograms, chest X-rays, B-ultrasound and other tests are normal, or who are evaluated as abnormal by the researcher but have no clinical significance.

Exclusion criteria

1. Subjects with an allergic constitution, including those with a history of severe drug hypersensitivity or allergy, and known to be allergic to the investigational drug or GLP-1 drugs or any component in the investigational drug (citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid and sodium hydroxide).

2. History of acute or chronic pancreatitis and pancreatic injury before screening. Subjects with symptomatic gallbladder disorders at screening.

3. History or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B before screening.

4. Have the following cardiovascular and cerebrovascular diseases within 6 months before screening: Decompensated cardiac insufficiency (New York Heart Association NYHA Class III or IV), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack.

5. During screening, 12-lead electrocardiogram: QTcF > 470 msec (for males) or > 480 msec (for females).

6. Those with a history of severe active infection within one month prior to screening.

7. Subjects with a history of malignant tumors within the past 5 years (except for basal cell carcinoma of ski, squamous cell carcinoma of skin or in situ cancer of cervix).

8. Subjects with severe trauma, gastrointestinal surgery, or other major surgical operations within 4 weeks before screening.

9. Subjects who are unwilling or unable to comply with the study procedures specified in the protocol, or who are deemed unsuitable for participating in this clinical study by any investigator.

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Cmax:Maximum plasma concentration.

Time frame:through study completion, an average of 36 days

concentration, descriptive

Primary/protocol endpoint

AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.

Time frame:through study completion, an average of 36 days

concentration, descriptive

Primary/protocol endpoint

AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.

Time frame:through study completion, an average of 36 days

concentration, descriptive

Secondary/protocol endpoint

AUC0-336 h:Area under the plasma concentration-time curve from time zero to 336 hours

Time frame:through study completion, an average of 36 days

concentration, descriptive

Secondary/protocol endpoint

Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration

Time frame:through study completion, an average of 36 days

time to event, event

Secondary/protocol endpoint

TEAE:Treatment Emergent Adverse Event

Time frame:through study completion, an average of 36 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.