Actively Recruiting
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
Led by Beijing QL Biopharmaceutical Co.,Ltd · Updated on 2026-04-20
40
Participants Needed
3
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.
CONDITIONS
Official Title
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand study procedures and provide written informed consent
- Male or female aged 18 to 75 years at consent
- Body mass index between 19.0 and 32.0 kg/m²
- Body weight of at least 50 kg for males and 45 kg for females
- Diagnosed with stable chronic kidney disease for at least 3 months
- Renal function classified by estimated glomerular filtration rate (eGFR) as normal (90-129 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), or severe impairment (15-29 mL/min)
- Stable renal function confirmed by two eGFR measurements during screening
You will not qualify if you...
- History of acute or chronic pancreatitis or pancreatic injury
- Personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2)
- History of moderate-to-severe anxiety, depression, or severe psychiatric disorders
- Any treated or untreated malignancy within 5 years before screening except basal cell carcinoma of the skin
- Obstructive uropathy or renal impairment from causes unrelated to intrinsic renal dysfunction in the renal insufficiency group
- Systolic blood pressure over 160 mmHg or diastolic pressure over 100 mmHg during screening
- Use of medications affecting renal tubular creatinine secretion or nephrotoxic drugs within 14 days or 5 half-lives before screening
- For normal renal function group: diseases of cardiovascular, respiratory, digestive, endocrine, hematologic, or neuropsychiatric systems within 1 year before screening
- Blood pressure outside 90-140 mmHg systolic or 50-90 mmHg diastolic range in the normal renal function group
- Use of any medications, including supplements, that may affect study outcomes within 14 days or 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
2
The First Affiliated Hospital Of Shandong First Medical Unversity
Jinan, Shandong, China, 250014
Actively Recruiting
3
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 250014
Actively Recruiting
Research Team
Y
Yujie Deng, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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