NCT07144098 Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
| NCT ID | NCT07144098 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Gan & Lee Pharmaceuticals. |
| Condition | Obesity/Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2026-07-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-08-12 with a primary completion date of 2026-07-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency. The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).
Eligibility 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.
Contact & Investigator
Liyuan Zhao Ph.D
STUDY DIRECTOR
Gan & Lee Pharmaceuticals.
Frequently Asked Questions
Who can join the NCT07144098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity/Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07144098 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07144098 currently recruiting?
Yes, NCT07144098 is actively recruiting participants. Contact the research team at liyuan.zhao@ganlee.com for enrollment information.
Where is the NCT07144098 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07144098 clinical trial?
NCT07144098 is sponsored by Gan & Lee Pharmaceuticals.. The principal investigator is Liyuan Zhao Ph.D at Gan & Lee Pharmaceuticals.. The trial plans to enroll 24 participants.
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