Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function

NCT ID: NCT07141030

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-11
• Study Completion Date: 2026-03-31

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 renal function and those with mild, moderate or severe renal impairment.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GZR18 injection

Group Type: EXPERIMENTAL

GZR18 injection

Intervention Type: DRUG

GZR18 injection:3mg

Interventions

GZR18 injection

GZR18 injection:3mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1.Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.

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

3.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; 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.

4.Subjects weighing ≥ 50 kg and 20 ≤ BMI ≤ 40 kg/m2 at screening.

5.Subjects with normal renal function must also meet the following conditions:

1. 90 mL/min ≤ individual's GFR < 130 mL/min at screening (see Appendix 2: Formulas Involved in the Protocol for the calculation formula).

2. Subjects with normal laboratory test results, vital signs, ECG, physical examination, chest AP view, abdominal B-ultrasound, and other examination results at screening or without clinically significant abnormalities as assessed by the investigator.

6.Subjects with renal impairment must also meet all of the following:

1. Mild renal impairment group: 60 mL/min ≤ individual's GFR < 90 mL/min at screening; moderate renal impairment group: 30 mL/min ≤ individual's GFR < 60 mL/min at screening; severe renal impairment group: 15 mL/min ≤ individual's GFR < 30 mL/min at screening.

2. Subjects with moderate and severe renal impairment should meet the diagnostic criteria for chronic kidney disease (outpatient medical records, hospitalization medical records or laboratory test results can be used as evidence). If the subject is receiving drug therapy, a stable medication regimen (at least within 2 weeks before administration) is required.

Exclusion Criteria

• 1.Subjects with allergic constitution, including those with a history of severe drug allergy or hypersensitivity reactions, and those known or suspected to be allergic to GLP-1 drugs or their excipients as considered by the investigator.

2.Subjects with a history of acute or chronic pancreatitis and pancreatic injury before screening; subjects with viral hepatitis, alcoholic liver disease, hepatic cirrhosis, autoimmune hepatitis and other liver diseases before screening; subjects with symptomatic gallbladder disease at screening.

3.Subjects who routinely receive dialysis or have a history of kidney transplantation or other organ transplantation before screening.

4.Subjects with severe infection, severe trauma, gastrointestinal surgery, or other major surgical operations within 6 months before screening.

5.Subjects with a history of moderate or major depression, suicidal tendency or suicidal behavior before screening; or other serious mental disorders (schizophrenia, bipolar affective disorder, etc.); or other psychiatric diseases that the investigator considers inappropriate for this study.

6. Subjects with a history of drug abuse or drug use within 1 year before screening; or subjects with positive result in a drug abuse screening (urine) (which cannot be justified by concurrent medications, such as those used for treating pain, anxiety, or insomnia as complications of renal disorder) at screening.

7.Subjects who have received a vaccine within 2 weeks before screening or are planning to be vaccinated during the study or within 1 month postdose.

8.Subjects who are positive for any indicator of human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening.

9.Subjects deemed unsuitable for inclusion by the investigator for other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gan & Lee Pharmaceuticals.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gan & Lee Pharmaceuticals

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Li yuan Zhao, Ph.D

Role: CONTACT

liyuan.zhao@ganlee.com

010-8059-5000

Other Identifiers

GZR18-BWM-106

Identifier Type: -

Identifier Source: org_study_id