Obesity/OverweightPhase 1NCT07144098
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
A Phase 1 study testing GZR18 injection in people with Obesity/Overweight, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity/Overweight
- What is being tested?
- GZR18 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2025to 26 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects:
- Subjects who fully understand the study contents, study procedures and possible risks, can follow the contraindications and restrictions specified in this protocol, and voluntarily sign the informed consent form.
- Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing the ICF.
- Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 19.0-32.0 kg/m2 (both inclusive).
- Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation or egg donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening.
- Only for Subjects with Liver Dysfunction:
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- Chronic liver insufficiency caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis or other reasons, and after comprehensive assessment by researchers, the disease is not in the rapid progression stage.
- Determined as grade A, B or C according to the Child-Pugh score, and no albumin was used within 21 days before screening.
- Researchers determine the physical condition of those who are eligible for this test based on medical history inquiry, physical examination, vital signs, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.), 12-lead electrocardiogram, chest X-ray, B-ultrasound, etc.
- Only for Subjects with Normal Liver Function:
- Matched with the subjects in the liver insufficiency group in terms of mean age (±10 years), sex ±1, mean weight (±10 kg), and mean BMI (±20%).
- Those whose clinical laboratory tests, vital signs, physical examinations, electrocardiograms, chest X-rays, B-ultrasound and other tests are normal, or who are evaluated as abnormal by the researcher but have no clinical significance.
Who cannot join
- 1. Subjects with an allergic constitution, including those with a history of severe drug hypersensitivity or allergy, and known to be allergic to the investigational drug or GLP-1 drugs or any component in the investigational drug (citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid and sodium hydroxide).
- 2. History of acute or chronic pancreatitis and pancreatic injury before screening. Subjects with symptomatic gallbladder disorders at screening.
- 3. History or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
- 4. Have the following cardiovascular and cerebrovascular diseases within 6 months before screening: Decompensated cardiac insufficiency (New York Heart Association NYHA Class III or IV), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack.
- 5. During screening, 12-lead electrocardiogram: QTcF > 470 msec (for males) or > 480 msec (for females).
- 6. Those with a history of severe active infection within one month prior to screening.
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- 7. Subjects with a history of malignant tumors within the past 5 years (except for basal cell carcinoma of ski, squamous cell carcinoma of skin or in situ cancer of cervix).
- 8. Subjects with severe trauma, gastrointestinal surgery, or other major surgical operations within 4 weeks before screening.
- 9. Subjects who are unwilling or unable to comply with the study procedures specified in the protocol, or who are deemed unsuitable for participating in this clinical study by any investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency.
The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).
- Conditions
- Obesity/Overweight
- Being tested
- GZR18 injection
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18 injectionDrug
3 mg-Control group
GZR18 injectionDrug
3 mg-mild liver insufficiency
GZR18 injectionDrug
3 mg-moderate liver insufficiency
GZR18 injectionDrug
3 mg-severe liver insufficiency
| Study group | Role | What they receive |
|---|---|---|
| GZR18 injection | Experimental | Not described Receives: Drug: GZR18 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax:Maximum plasma concentration.
Measured: through study completion, an average of 36 days
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Measured: through study completion, an average of 36 days
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Measured: through study completion, an average of 36 days
Secondary outcomes (3)
AUC0-336 h：Area under the plasma concentration-time curve from time zero to 336 hours
Measured: through study completion, an average of 36 days
Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration
Measured: through study completion, an average of 36 days
TEAE：Treatment Emergent Adverse Event
Measured: through study completion, an average of 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start12 Aug 2025
- Primary completion12 Jul 2026 (estimated)
- Study completion26 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity/OverweightStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyuan Zhao Ph.D, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144098
- Sponsor's protocol ID
- GZR18-BWM-107
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
- ClinicalTrials.gov ID
- NCT07144098
- Acronym / sponsor ID
- GZR18-BWM-107
- Conditions
- Obesity/Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 12 Jul 2026 (estimated)
- Study completion
- 26 Jan 2027 (estimated)
- First posted
- 27 Aug 2025 (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 adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency.
The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GZR18 injection | Experimental | Drug: GZR18 injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All Subjects:
- Matched with the subjects in the liver insufficiency group in terms of mean age (±10 years), sex ±1, mean weight (±10 kg), and mean BMI (±20%).
- Those whose clinical laboratory tests, vital signs, physical examinations, electrocardiograms, chest X-rays, B-ultrasound and other tests are normal, or who are evaluated as abnormal by the researcher but have no clinical significance.
Key exclusion criteria (9 listed)
- 1. Subjects with an allergic constitution, including those with a history of severe drug hypersensitivity or allergy, and known to be allergic to the investigational drug or GLP-1 drugs or any component in the investigational drug (citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid and sodium hydroxide).
- 2. History of acute or chronic pancreatitis and pancreatic injury before screening. Subjects with symptomatic gallbladder disorders at screening.
- 3. History or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
- 4. Have the following cardiovascular and cerebrovascular diseases within 6 months before screening: Decompensated cardiac insufficiency (New York Heart Association NYHA Class III or IV), angina unstable or myocardial infarction, history of heart valve replacement surgery, coronary artery bypass grafting or other invasive cardiovascular surgery including percutaneous coronary intervention, ischemic or hemorrhagic stroke (excluding lacunar infarction), or transient ischemic attack.
- 5. During screening, 12-lead electrocardiogram: QTcF > 470 msec (for males) or > 480 msec (for females).
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 |
|---|---|---|
| GZR18 injection3 mg-Control group | Drug | GZR18 injection |
| GZR18 injection3 mg-mild liver insufficiency | Drug | GZR18 injection |
| GZR18 injection3 mg-moderate liver insufficiency | Drug | GZR18 injection |
| GZR18 injection3 mg-severe liver insufficiency | Drug | GZR18 injection |
Primary outcome
Cmax:Maximum plasma concentration.
Time frame: through study completion, an average of 36 days
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Time frame: through study completion, an average of 36 days
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Time frame: through study completion, an average of 36 days
3 secondary outcomes
AUC0-336 h：Area under the plasma concentration-time curve from time zero to 336 hours
Time frame: through study completion, an average of 36 days
Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration
Time frame: through study completion, an average of 36 days
TEAE：Treatment Emergent Adverse Event
Time frame: through study completion, an average of 36 days
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 27 Aug 2025.
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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.
Liyuan Zhao Ph.D study director
Gan & Lee Pharmaceuticals.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR18 injection in people with Obesity/Overweight, run by Gan & Lee Pharmaceuticals. at 1 site 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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Li yuan Zhao, Ph.D (010-8059-5000, liyuan.zhao@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax:Maximum plasma concentration. (time frame: through study completion, an average of 36 days). 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 27 Aug 2025.