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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
Lead sponsor
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
•Cmax•AUC at 0 h to last observation time-point after a single dose•AUC 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
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
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 endpointsCmax:Maximum plasma concentration
Time frame:through study completion, an average of 36 days
concentration, descriptive
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
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
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
Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration
Time frame:through study completion, an average of 36 days
time to event, event
TEAE:Treatment Emergent Adverse Event
Time frame:through study completion, an average of 36 days
descriptive
Provenance
Sources
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.