Actively Recruiting
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-11-21
32
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects sign informed consent and understand the study and possible side effects
- Male or female subjects aged 18 to 75 years
- Women of childbearing potential are not pregnant or breastfeeding, have a negative pregnancy test, and agree to use effective contraception for 8 weeks after dosing
- Subjects weigh at least 50 kg and have a BMI between 20 and 40 at screening
- Subjects with normal kidney function have a glomerular filtration rate (GFR) between 90 and less than 130 mL/min and normal lab tests, vital signs, ECG, physical exam, chest X-ray, and abdominal ultrasound
- Subjects with renal impairment have GFR between 15 and less than 90 mL/min, meeting criteria for mild, moderate, or severe impairment
- Subjects with moderate or severe impairment have documented chronic kidney disease and stable medication regimen for at least 2 weeks before dosing
You will not qualify if you...
- History of severe drug allergy or allergy to GLP-1 drugs or their ingredients
- History of acute or chronic pancreatitis or pancreatic injury; liver diseases such as hepatitis, cirrhosis, or autoimmune hepatitis; or symptomatic gallbladder disease
- Routine dialysis or history of kidney or other organ transplantation
- Severe infection, major surgery, or trauma within 6 months before screening
- History of moderate or major depression, suicidal behavior, schizophrenia, bipolar disorder, or other serious mental illness
- History of drug abuse within 1 year or positive drug abuse screening at screening
- Vaccination within 2 weeks before screening or planned vaccination during the study and 1 month after dosing
- Positive for HIV, syphilis, hepatitis B, or hepatitis C at screening
- Other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gan & Lee Pharmaceuticals
Beijing, China
Actively Recruiting
Research Team
L
Li yuan Zhao, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here