A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants

NCT07443059 | Recruiting Phase 1

• 1 other identifier: BJQL-ZT002-1006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (4)

A group (Mild Renal Impairment)

EXPERIMENTAL

Drug: Zovaglutide

B group (Moderate Renal Impairment)

EXPERIMENTAL

Drug: Zovaglutide

C group (Severe Renal Impairment)

EXPERIMENTAL

Drug: Zovaglutide

D group (Healthy Control)

EXPERIMENTAL

Drug: Zovaglutide

Interventions

Zovaglutide DRUG

Receive a single dose , SC

Also known as: ZT002 Injection

A group (Mild Renal Impairment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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);
• 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:
• 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).
• Participants in the renal insufficiency group will not be included in this study if they meet any of the following criteria:
• 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).
• Participants in the normal renal function group will not be included in this study if they meet any of the following criteria:
• 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.
• 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)
• 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;

Sponsors & Collaborators

• Beijing QL Biopharmaceutical Co.,Ltd: lead

Study Sites (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

NOT YET RECRUITING

The First Affiliated Hospital Of Shandong First Medical Unversity

Jinan, Shandong, 250014, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 250014, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Zhao, PhD

  The First Affiliated of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Deng, PhD

CONTACT

+86-010-61702599; yujie@qlbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): March 19, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (3)