Pharmacokinetics and safety of GZR18 injection in adults with and without liver insufficiency
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
This will test a single dose of GZR18 injection to see how the drug is processed and whether it is safe in adults with normal liver function and in adults with mild, moderate, or severe liver insufficiency.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Gan & Lee Pharmaceuticals. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07144098 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, open-label, single-dose, parallel Phase 1 trial comparing pharmacokinetics and safety of GZR18 in participants with normal liver function and those with varying degrees of chronic liver insufficiency. Each participant is followed for up to 50 days, including up to 14 days of screening, an 8-day dosing and observation period, and a 28-day follow-up. The study collects blood samples for PK analysis and monitors adverse events and laboratory measures to characterize safety across liver-function groups. Enrollment criteria include adults aged 18–75 with specified weight and BMI ranges, and women of childbearing potential must use effective contraception.
Who should consider this trial
Good fit: Adults aged 18–75 years with weight ≥50 kg (men) or ≥45 kg (women), BMI 19.0–32.0 kg/m2, and either normal liver function or chronic liver insufficiency of mild, moderate, or severe degree are the intended participants.
Not a fit: People who are pregnant or breastfeeding, outside the specified age or BMI/weight ranges, or with acute unstable medical conditions are unlikely to benefit from participating in this single-dose PK/safety study.
Why it matters
Potential benefit: If successful, results could clarify safe dosing and expected drug levels of GZR18 in people with liver impairment and guide dosing recommendations for future studies.
How similar studies have performed: Single-dose PK and safety studies in patients with liver impairment are a standard first step and have historically helped adjust dosing for many drugs, but GZR18's profile in liver-impaired patients is being characterized here for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Gan & Lee Pharmaceuticals — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Li yuan Zhao, Ph.D
- Email: liyuan.zhao@ganlee.com
- Phone: 010-8059-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.