Overweight , Obesity
Conditions
Brief 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.
Interventions
DRUGZovaglutide
Receive a single dose , SC
Sponsors
Beijing QL Biopharmaceutical Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
* 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. 7. Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period; 8. 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). Participants in the normal renal function group will not be included in this study if they meet any of the following criteria: 9. Those who have suffered from diseases of other systems, such as the cardiovascular, respiratory, digestive, endocrine, hematologic, or neuropsychiatric systems, within 1 year prior to screening, and are considered by the investigator to be unsuitable for participation in this study. 10. Those with systolic blood pressure exceeding 90-140 mmHg (including both end values) or diastolic blood pressure exceeding 50-90 mmHg (including both end values) 11. Use of any medication, including prescription drugs, over-the-counter medication, Chinese herbal medicines, and dietary supplements (e.g., vitamins and minerals that may affect study outcomes) within 14 days or 5 half-lives (whichever is longer) prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t). | Start of Treatment up to Day 50 |
| Maximum Concentration of ZT002 (Cmax) | Start of Treatment up to Day 50 |
| Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞) | Start of Treatment up to Day 50 |
| Time to maximum concentration (Tmax) | From baseline to Day 50 |
| Apparent terminal half-life (t1/2) | From baseline to Day 50 |
| Apparent clearance (CL/F) | From baseline to Day 50 |
| Incidence and severity of adverse events | Screening period up to Day 50 |
Countries
China
Contacts
CONTACTYujie Deng, PhD
PRINCIPAL_INVESTIGATORWei Zhao, PhD
The First Affiliated of Shandong First Medical University
Outcome results
None listed