Actively Recruiting
A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single-dose of Zovaglutide (ZT002 Injection) in Participants With Different Degrees of Renal Insufficiency and Matched Participants With Normal Renal Function
Led by Beijing QL Biopharmaceutical Co.,Ltd · Updated on 2026-04-20
40
Participants Needed
3
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetic (PK) characteristics and safety of a single subcutaneous injection of Zovaglutide (ZT002 Injection) in adults with different levels of kidney function, including those with normal renal function and varying degrees of renal insufficiency. This phase I, open-label study aims to understand how the drug behaves in the body and its safety profile across these groups. Participants are assigned to one of four groups based on kidney function: mild, moderate, severe renal impairment, or healthy controls. Each participant receives a single dose of Zovaglutide by subcutaneous injection. The study monitors how the drug is processed in the body over time, with follow-up lasting up to 50 days after treatment. During the study, participants will undergo regular assessments including blood sampling to measure drug concentration and kidney function, and monitoring for any adverse events. The primary outcomes include measurements such as the drug's concentration over time, maximum concentration, half-life, clearance, and time to maximum concentration. Safety is closely observed from screening through day 50, ensuring comprehensive monitoring during the study period.
CONDITIONS
Brief 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...
- Ability to understand the trial procedures and possible adverse events and provide written informed consent
- Male or female, aged 18 to 75 years at the time of consent
- Body mass index (BMI) between 19.0 and 32.0 kg/m²
- Body weight at least 50 kg for males and 45 kg for females
- Diagnosed with stable, chronic renal disease for at least 3 months
- Renal function assessed by estimated glomerular filtration rate (eGFR) within specified ranges for different groups
- 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
- History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history
- History of depression, anxiety disorder, moderate-to-severe anxiety/depressive state, 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 caused by non-intrinsic kidney issues and deemed unsuitable for the trial
- Systolic blood pressure over 160 mmHg or diastolic over 100 mmHg during screening
- Use of medications affecting renal tubular creatinine secretion or nephrotoxic drugs within 14 days prior to screening
- For normal renal function group: diseases of cardiovascular, respiratory, digestive, endocrine, hematologic, or neuropsychiatric systems within 1 year prior to screening
- Blood pressure outside 90-140 mmHg systolic or 50-90 mmHg diastolic in normal renal function group
- Use of any medication including supplements affecting study outcomes within 14 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 50 days
Participants receive a single dose of Zovaglutide by subcutaneous injection.
Multiple visits for pharmacokinetic sampling and safety assessments up to Day 50
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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