RecruitingOverweight , Obesity
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: Beijing QL Biopharmaceutical Co.,Ltd
You may qualify if…
- ✓ 1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- ✓ 2. Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
- ✓ 3. Body mass index (BMI) 19.0 - 32.0 kg/m²(both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
- ✓ 4. Diagnosed as stable, chronic renal disease for at least 3 months.
- ✓ 5. Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
- ✓ Normal renal function: 90-129 mL/min (inclusive); Mild impairment: 60-89 mL/min (inclusive); Moderate impairment: 30-59 mL/min (inclusive); Severe impairment: 15-29 mL/min (inclusive);
- ✓ 6. Stable renal function, assessed by two eGFR during screening.
You may not qualify if…
- ✕ All participants will not be included in this study if they meet any of the following criteria:
- ✕ 1. History of acute or chronic pancreatitis, or pancreatic injury.
- ✕ 2. History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- ✕ 3. History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
- ✕ 4. Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin)
- ✕ 5. Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- ✕ Participants in the renal insufficiency group will not be included in this study if they meet any of the following criteria:
- ✕ 6. Those with obstructive uropathy (e.g., urinary tract obstruction due to calculi or space-occupying lesions) or renal impairment caused by other etiologies unrelated to intrinsic renal dysfunction (e.g., renal tumors) and/or renal diseases (e.g., renal artery stenosis, nephrotoxic drugs, severe infections, hypovolemia, heart failure, etc.), and deemed by the investigator as unsuitable for participation in this clinical trial.
Source: ClinicalTrials.gov · NCT07443059 · last updated 2026-04-20