Zovaglutide injection for people with reduced kidney function and healthy volunteers

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

This phase 1 test gives a single subcutaneous dose of Zovaglutide to adults with varying degrees of kidney impairment and to healthy adults to see how the drug is processed and whether it is safe.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd (industry)
• Locations: 3 sites (Xiamen, Fujian and 2 other locations)
• Trial ID: NCT07443059 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-dose, parallel phase 1 trial comparing pharmacokinetics and safety of ZT002 (Zovaglutide) in adults with normal renal function and those with mild, moderate, or severe chronic renal impairment. Participants receive one subcutaneous injection of Zovaglutide and undergo timed blood sampling to measure drug concentrations and PK parameters. Safety monitoring includes adverse event reporting, laboratory tests, and clinical assessments, with key exclusions such as a history of pancreatitis. Enrollment targets adults aged 18–75 with BMI 19.0–32.0 kg/m² and stable renal function categorized by eGFR ranges.

Who should consider this trial

Good fit: Adults 18–75 years old with BMI 19.0–32.0 kg/m² who either have stable chronic kidney disease for at least three months across specified eGFR categories or are matched healthy volunteers with normal eGFR, and who can provide informed consent and attend study visits.

Not a fit: People with recent acute kidney injury, those on dialysis, a history of pancreatitis, pregnant people, or anyone outside the specified age, BMI, or eGFR ranges are unlikely to benefit from or be eligible for this single-dose PK study.

Why it matters

Potential benefit: If successful, the results could help define safer dosing recommendations for Zovaglutide in people with reduced kidney function.

How similar studies have performed: Single-dose PK and safety studies of other GLP-1 receptor agonists have informed dosing in renal impairment, but published data specific to Zovaglutide in this population are limited.

Eligibility criteria

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;

Where this trial is running

Xiamen, Fujian and 2 other locations

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital Of Shandong First Medical Unversity — Jinan, Shandong, China (RECRUITING)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Wei Zhao, PhD — The First Affiliated of Shandong First Medical University
• Study coordinator: Yujie Deng, PhD

Conditions: Overweight , Obesity