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RecruitingPhase 1

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

To Assess the Pharmacokinetic (PK) Differences of GZR18 Injection Between Subjects With Renal Impairment and Those With Normal Renal Function, Providing a Basis for Establishing a Clinical Dosing Regimen for Patients With Renal Impairment

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

32

estimated

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

BMI ≤40

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 IDNCT07141030
Org study IDGZR18-BWM-106

Timeline

Milestones

Study start2025-04-11actual
Study first posted2025-08-26actual
Primary completion2025-10-09actual
Last update posted2025-11-21actual
Study completion2026-03-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

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.