ClinicalTrials.gg
Active, not recruitingNCT07443059Updated Oct 21, 2026

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

A Phase 1 interventional study of Zovaglutide and Zovaglutide in Overweight , Obesity, sponsored by Beijing QL Biopharmaceutical Co.,Ltd. Active, not recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Beijing QL Biopharmaceutical Co.,Ltd · Phase 1, Interventional, and Treatment

Updated Oct 21, 2026Now Active, not recruitingGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd — 2 open to participants now, 7 under way, 1 of them phase 3. Obesity · Beijing QL Biopharmaceutical Co.,Ltd.

Planned enrollment
7th of 10
40 · median 77
Started
2026
with 5 others
Phase 1
6 of 10
1 open now
Registered
6th of 10
by date

Among the 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd, this one is the 7th largest by planned enrollment, is one of 6 that started in 2026, is one of 6 in phase 1, and was the 6th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

2 of the 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Overweight , Obesity

Browse trials for

04

In context

Obesity Reclassified

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

This study's planned enrollment of 40 is below the median of 67 across 9,016 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written ;
  2. Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
  3. (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 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

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 (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;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

06

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    A group (Mild Renal Impairment)

    Drug: Zovaglutide

  • Experimental
    B group (Moderate Renal Impairment)

    Drug: Zovaglutide

  • Experimental
    C group (Severe Renal Impairment)

    Drug: Zovaglutide

  • Experimental
    D group (Healthy Control)

    Drug: Zovaglutide

Interventions

  • DrugZovaglutide

    Receive a single dose , SC

    Also known as: ZT002 Injection

  • DrugZovaglutide

    Receive a single dose , SC

    Also known as: ZT002 Injection

  • DrugZovaglutide

    Receive a single dose , SC

    Also known as: ZT002 Injection

  • DrugZovaglutide

    Receive a single dose , SC

    Also known as: ZT002 Injection

07

What researchers measure

Primary outcomes

  1. Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t).

    Time frame: Start of Treatment up to Day 50

  2. Maximum Concentration of ZT002 (Cmax)

    Time frame: Start of Treatment up to Day 50

  3. Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)

    Time frame: Start of Treatment up to Day 50

  4. Time to maximum concentration (Tmax)

    Time frame: From baseline to Day 50

  5. Apparent terminal half-life (t1/2)

    Time frame: From baseline to Day 50

  6. Apparent clearance (CL/F)

    Time frame: From baseline to Day 50

  7. Incidence and severity of adverse events

    Time frame: Screening period up to Day 50

08

Study locations

3 sites
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 7 months is below that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2026
First posted
Mar 2, 2026
StartActual
Apr 13, 2026
Primary completionEst.
Dec 3, 2026
CompletionEst.
Mar 19, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07443059
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Apr 13, 2026
Primary completion
Dec 3, 2026 (estimated)
Completion
Mar 19, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Wei Zhao, PhD
principal investigator · The First Affiliated of Shandong First Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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