A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Health… (NCT07443059) | Clinical Trial Compass
RecruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
China40 participantsStarted 2026-04-13
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
✓. Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
✓. 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.
✓. Diagnosed as stable, chronic renal disease for at least 3 months.
✓. Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
✓. Stable renal function, assessed by two eGFR during screening.
Exclusion criteria
✕. 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, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
✕. 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)
✕. 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).
What they're measuring
1
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t).
Timeframe: Start of Treatment up to Day 50
2
Maximum Concentration of ZT002 (Cmax)
Timeframe: Start of Treatment up to Day 50
3
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
✕. 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.
✕. Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;
✕. Those who have received any medications known to alter renal tubular creatinine secretion (e.g., cimetidine, trimethoprim, or cibenzoline, or salicylates excluding topical formulations), competitive inhibitors of renal tubular secretion (e.g., probenecid), or nephrotoxic drugs (e.g., non-steroidal anti-inflammatory drugs, polymyxins, vancomycin) within 14 days prior to screening or 5 half-lives (whichever is longer).