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A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants | Clinical Trials | Clareo Health

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

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

NCT07443059•Beijing QL Biopharmaceutical Co.,Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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).
+4 more criteria

Locations (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The First Affiliated Hospital Of Shandong First Medical Unversity

Jinan, Shandong, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

April 10, 2026

Primary Completion Date

December 3, 2026

Completion Date

March 19, 2027

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Overweight , Obesity

Interventions

Zovaglutide

DRUG

Zovaglutide

DRUG

Zovaglutide

DRUG

Zovaglutide

DRUG

Contacts

Yujie Deng, PhD

CONTACT

+86-010-61702599 yujie@qlbiopharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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