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

NCT07144098 | Recruiting Phase 1

• 1 other identifier: GZR18-BWM-107
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity/Overweight

Outcome Measures

Primary Outcomes (3)

• Cmax:Maximum plasma concentration.

  through study completion, an average of 36 days

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

  through study completion, an average of 36 days

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

  through study completion, an average of 36 days

Secondary Outcomes (3)

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

  through study completion, an average of 36 days

• Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration

  through study completion, an average of 36 days

• TEAE：Treatment Emergent Adverse Event

  through study completion, an average of 36 days

Study Arms (1)

GZR18 injection

EXPERIMENTAL

Drug: GZR18 injection

Interventions

GZR18 injection DRUG

3 mg-Control group

GZR18 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Subjects:
• 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.
• Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing the ICF.
• 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).
• 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:
• 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.
• Determined as grade A, B or C according to the Child-Pugh score, and no albumin was used within 21 days before screening.
• 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:
• 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%).
• 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.

You may not qualify if:

• \. 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).
• \. History of acute or chronic pancreatitis and pancreatic injury before screening. Subjects with symptomatic gallbladder disorders at screening.
• \. History or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
• \. 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.
• \. During screening, 12-lead electrocardiogram: QTcF \> 470 msec (for males) or \> 480 msec (for females).
• \. Those with a history of severe active infection within one month prior to screening.
• \. 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).
• \. Subjects with severe trauma, gastrointestinal surgery, or other major surgical operations within 4 weeks before screening.
• \. 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.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Gan & Lee Pharmaceuticals

Beijing, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liyuan Zhao Ph.D

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Central Study Contacts

Li yuan Zhao, Ph.D

CONTACT

010-8059-5000; liyuan.zhao@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): July 12, 2026
• Study Completion (Estimated): January 26, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CN (1)