Overweight, ObesityPhase 1NCT07916194
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment 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, 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 13 Nov 2026to 25 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants:
- Male or female subjects aged≥18 years and≤75 years (both inclusive) at the time of signing the Informed Consent Form (ICF).
- Body Mass Index (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 Child-Pugh scoring
Who cannot join
- 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 clinically significant gastric emptying disorders.
- Medical history of hypoglycemia within 6 months before screening;
- eGFR<60 mL/min/1.73m²
Show all 16Show fewer
- 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 hemoglobin <70 grams per deciliter (g/L)
- Have platelet <50×10^9/L
- HbA1c ≥ 8.0% or fasting blood glucose ≥ 11.10 mmol/L at screening.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Mengchang Yang, Doctor, 18140049936, ymc681@126.com
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Xian Yu, Doctor, 18512356862, 22168398@qq.com
Henan Infectious Diseases Hospital & The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000
Shuang Li, Master, 13938529645, li36918@163.com
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 Varying Degrees of Hepatic Impairment and Matched Participants With Normal Hepatic Function
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.
- 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
All subjects will be treated with a single subcutaneous injection of Zovaglutide
ZovaglutideDrug
All subjects will be treated with a single subcutaneous injection of Zovaglutide
ZovaglutideDrug
All subjects will be treated with a single subcutaneous injection of Zovaglutide.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Mild Hepatic Impairment) | Experimental | Not described Receives: Drug: Zovaglutide |
| Group B (Moderate Hepatic Impairment) | Experimental | Not described Receives: Drug: Zovaglutide |
| Group C (Normal hepatic function) | 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 Infinity (AUC0-∞)
Measured: Start of treatment up to Day 36
Maximum Concentration of ZT002 (Cmax)
Measured: Start of treatment up to Day 36
Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t)
Measured: Start of treatment up to Day 36
Secondary outcomes (4)
Time to maximum concentration (Tmax)
Measured: Start of treatment up to Day 36
Apparent terminal half-life (t1/2)
Measured: Start of treatment up to Day 36
Apparent clearance (CL/F)
Measured: Start of treatment up to Day 36
Incidence and severity of adverse events
Measured: Start of treatment up to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start13 Nov 2026 (estimated)
- Primary completion19 Jun 2027 (estimated)
- Study completion25 Sep 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mengchang Yang, Doctor, Principal investigator, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916194
- Sponsor's protocol ID
- BJQL-ZT002-1009
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single Dose of Zovaglutide (ZT002 Injection) in Participants With Varying Degrees of Hepatic Impairment and Matched Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07916194
- Acronym / sponsor ID
- BJQL-ZT002-1009
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 19 Jun 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Mild Hepatic Impairment) | Experimental | Drug: Zovaglutide |
| Group B (Moderate Hepatic Impairment) | Experimental | Drug: Zovaglutide |
| Group C (Normal hepatic function) | Experimental | Drug: Zovaglutide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged≥18 years and≤75 years (both inclusive) at the time of signing the Informed Consent Form (ICF).
- Body Mass Index (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 chronic mild and moderate hepatic impairment, assessed by Child-Pugh scoring
Key exclusion criteria (16 listed)
- 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 clinically significant gastric emptying disorders.
- Medical history of hypoglycemia within 6 months before screening;
- eGFR<60 mL/min/1.73m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZovaglutideAll subjects will be treated with a single subcutaneous injection of Zovaglutide | Drug | Group A (Mild Hepatic Impairment) |
| ZovaglutideAll subjects will be treated with a single subcutaneous injection of Zovaglutide | Drug | Group B (Moderate Hepatic Impairment) |
| ZovaglutideAll subjects will be treated with a single subcutaneous injection of Zovaglutide. | Drug | Group C (Normal hepatic function) |
Primary outcome
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
Maximum Concentration of ZT002 (Cmax)
Time frame: Start of treatment up to Day 36
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
4 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Start of treatment up to Day 36
Apparent terminal half-life (t1/2)
Time frame: Start of treatment up to Day 36
Apparent clearance (CL/F)
Time frame: Start of treatment up to Day 36
Incidence and severity of adverse events
Time frame: Start of treatment up to Day 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Overweight, Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mengchang Yang, Doctor principal investigator
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zovaglutide in people with Overweight, Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donglei Wang (+8613932155055, wang.donglei@qlbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.