Overweight , ObesityPhase 1NCT07443059
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
A Phase 1 study testing Zovaglutide in people with Overweight , Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- Zovaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesChina
- Study dates
- 13 Apr 2026to 19 Mar 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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;
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 250014
The First Affiliated Hospital Of Shandong First Medical Unversity
Jinan, Shandong, 250014
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
About this study
Official title: 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 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
- Being tested
- Zovaglutide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZovaglutideDrug
Also called ZT002 Injection
Receive a single dose , SC
ZovaglutideDrug
Also called ZT002 Injection
Receive a single dose , SC
ZovaglutideDrug
Also called ZT002 Injection
Receive a single dose , SC
ZovaglutideDrug
Also called ZT002 Injection
Receive a single dose , SC
| Study group | Role | What they receive |
|---|---|---|
| A group (Mild Renal Impairment) | Experimental | Not described Receives: Drug: Zovaglutide |
| B group (Moderate Renal Impairment) | Experimental | Not described Receives: Drug: Zovaglutide |
| C group (Severe Renal Impairment) | Experimental | Not described Receives: Drug: Zovaglutide |
| D group (Healthy Control) | Experimental | Not described Receives: Drug: Zovaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t).
Measured: Start of Treatment up to Day 50
Maximum Concentration of ZT002 (Cmax)
Measured: Start of Treatment up to Day 50
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
Measured: Start of Treatment up to Day 50
Time to maximum concentration (Tmax)
Measured: From baseline to Day 50
Apparent terminal half-life (t1/2)
Measured: From baseline to Day 50
Apparent clearance (CL/F)
Measured: From baseline to Day 50
Incidence and severity of adverse events
Measured: Screening period up to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start13 Apr 2026
- Primary completion3 Dec 2026 (estimated)
- Study completion19 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, PhD, Principal investigator, The First Affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443059
- Sponsor's protocol ID
- BJQL-ZT002-1006
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No