ClinicalTrials.gg
Not yet recruitingNCT07916194Updated Nov 4, 2026

A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants

A Phase 1 interventional study of Zovaglutide and Zovaglutide in Overweight, Obesity, sponsored by Beijing QL Biopharmaceutical Co.,Ltd. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

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 Other

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a single-dose, open-label, non-randomized, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with varying degrees of Hepatic Impairment and matched participants with normal hepatic function.

02

Conditions studied

  • Overweight, Obesity

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 24 is below the median of 67 across 9,006 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 →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

All participants:

  • Male or female subjects aged≥18 years and≤75 years (both inclusive) at the time of signing the Form (ICF).
  • (Body mass index (BMI) 18.0 - 32.0 kg/m² (both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
  • Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent.

Participants with Hepatic Impairment:

  • Participants with chronic mild and moderate hepatic impairment, assessed by scoring

Exclusion criteria

Exclusion Criteria:

All participants:

  • History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
  • 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).or any GI disease which impacts gastric emptying
  • Have a history of severe GI disease within 6 months before screening , or have received GI surgery (appendectomy, cholecystectomy are excepted), or gastric emptying disorders.
  • Medical history of hypoglycemia within 6 months before screening;
  • \<60 mL/min/1.73m²

Participants with Hepatic Impairment:

  • Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;
  • Have a severe portal shunt or prior portosystemic shunt within 3 months before screening;
  • Severe ascites and/or pleural effusion requiring paracentesis;
  • Have other causes of hepatic injury unrelated to hepatic parenchymal disease and/or cholestatic liver disease at screening;.
  • History of acute liver failure, esophagogastric variceal bleeding within 6 months before screening;
  • History of Hepatic encephalopathy of Grade 3 or 4.
  • Have \<70 grams per deciliter (g/L)
  • Have \<50×10\^9/L
  • ≥ 8.0% or fasting blood glucose ≥ 11.10 mmol/L at screening.
Terms in these criteria, in plain language(8)

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.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

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

Study arms

  • Experimental
    Group A (Mild Hepatic Impairment)

    Drug: Zovaglutide

  • Experimental
    Group B (Moderate Hepatic Impairment)

    Drug: Zovaglutide

  • Experimental
    Group C (Normal hepatic function)

    Drug: Zovaglutide

Interventions

  • DrugZovaglutide

    All subjects will be treated with a single subcutaneous injection of Zovaglutide

  • DrugZovaglutide

    All subjects will be treated with a single subcutaneous injection of Zovaglutide

  • DrugZovaglutide

    All subjects will be treated with a single subcutaneous injection of Zovaglutide.

06

What researchers measure

Primary outcomes

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

    Time frame: Start of treatment up to Day 36

  2. Maximum Concentration of ZT002 (Cmax)

    Time frame: Start of treatment up to Day 36

  3. 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 36

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: Start of treatment up to Day 36

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

    Time frame: Start of treatment up to Day 36

  3. Apparent clearance (CL/F)

    Time frame: Start of treatment up to Day 36

  4. Incidence and severity of adverse events

    Time frame: Start of treatment up to Day 36

07

Study locations

3 sites
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality 400000, China
  • Henan Infectious Diseases Hospital & The Sixth People's Hospital of Zhengzhou
    Zhengzhou, Henan 450000, China
  • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

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
NCT07916194
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 13, 2026 (estimated)
Primary completion
Jun 19, 2027 (estimated)
Completion
Sep 25, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Donglei Wang
Contact
wang.donglei@qlbiopharm.com
+8613932155055
Kun Guan
Contact
guan.kun@qlbiopharm.com
+8615040353238
Mengchang Yang, Doctor
principal investigator · Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

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

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