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DiabetesPhase 1NCT07193147

Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment

A Phase 1 study testing GZR4 in people with Diabetes, run by Gan & Lee Pharmaceuticals. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
GZR4
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
20 Oct 2025to 4 Nov 2026
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

  • Subjects must meet all of the following inclusion criteria to be included in the study.
  • Subjects must fully understand the study contents, study procedures and possible risks and voluntarily sign the informed consent form;
  • Male or female subjects aged ≥ 18 years and ≤ 75 years;
  • Subjects should have no plans for fertility, sperm, or egg donation during the study and for 8 weeks postdose. They should be willing to use effective contraceptive measures during the study and for 8 weeks postdose, be surgically sterilized, or be female subjects who have reached menopause.
  • Only for Subjects with Hepatic Impairment: Subjects with chronic hepatic impairment caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other reasons;
  • Only for Subjects with Hepatic Impairment: Subjects with a prior diagnosis of hepatic cirrhosis confirmed through liver biopsy or other medical imaging techniques;
  • Only for Subjects with Hepatic Impairment: Subjects who have not received albumin within 14 days and are classified as Class A, B, or C according to the Child-Pugh score, with hepatic impairment resulting from prior primary liver disorders;
  • Only for Subjects with Hepatic Impairment: Subjects with normal or abnormal and not clinically significant vital signs, physical examination, laboratory tests (hematology, blood chemistry, coagulation function and urinalysis), 12-lead ECG, chest X-ray and B-ultrasonography.

Who cannot join

  • Subjects who meet any of the following criteria should not be enrolled in this study.
  • Subjects with an allergic constitution, including a history of severe drug allergy or drug allergic reactions, who are known to be allergic to the investigational drug or its excipients (glycerol, phenol, m-cresol, zinc acetate dihydrate, sodium chloride, and citric acid monohydrate);
  • Subjects with decompensated cardiac failure (NYHA Class III or IV) or those diagnosed with or highly suspected of having unstable angina pectoris or acute myocardial infarction, as well as those with malignant arrhythmias (such as ventricular fibrillation and sustained ventricular tachycardia) within 3 months before screening; subjects with a history of heart valve replacement surgery, coronary artery bypass grafting, or other invasive cardiovascular procedures, including percutaneous coronary intervention, as well as those who have experienced ischemic or hemorrhagic strokes (excluding lacunar infarctions) or transient ischemic attacks within 6 months before screening;
  • Subjects with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring systemic anti-infective therapy at screening (excluding hepatitis B and C in the hepatic impairment group), those with a history of severe active infection within 1 month before screening, or those who developed any acute infection requiring systemic anti-infective therapy within 2 weeks predose;
  • Subjects with a history of drug abuse or drug addiction within 1 year before screening. Additionally, subjects with a positive urine drug abuse screening result predose (that cannot be attributed to concomitant medication) or a positive alcohol screening result;
  • Subjects who are heavy smokers or alcohol consumers within 6 months before screening (consuming ≥ 14 units of alcohol per week: 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine; smoking ≥ 5 cigarettes per day), or those unable to abstain from smoking and alcohol for 48 h predose and during the study;
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  • Subjects who ingest grapefruit juice, food or beverage rich in methylxanthine (such as coffee, tea, cola, chocolate and functional drinks) within 7 days prior to dosing, or have strenuous exercise and other factors affecting drug absorption, distribution, metabolism and excretion, and cannot withdraw during the study;
  • Pregnant or lactating women, women of child-bearing potential (WOCBP) with positive pregnancy test results at screening, or female subjects who have engaged in unprotected sexual intercourse within 2 weeks before screening;
  • 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.
  • Subjects with hepatic impairment ：Subjects with a history of chronic or serious diseases in the circulatory system, digestive system, urinary system, immune system, blood system, endocrine and metabolic system, or mental and nervous system, or those who have the above conditions at screening that may interfere with the study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gan & Lee Pharmaceuticals Shandong Co., Ltd.

    Linyi, Shandong, 276000

Other trials in China

About this study

Official title: A Single Dose Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.

Conditions
Diabetes
Being tested
GZR4
Keywords
GZR4 insulin
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GZR4Drug

    GZR4 s.c., single-dose

Study groups in NCT07193147
Study groupRoleWhat they receive
GZR4 injectionExperimentalNot described
Receives: Drug: GZR4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Maximum plasma concentration

    Measured: through study completion, an average of 29 days

  2. 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 29 days

Secondary outcomes (4)

  1. 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 29 days

  2. AUC0-168h

    Area under the plasma concentration-time curve from time zero to 168 hours

    Measured: Through study completion, an average of 29 days

  3. Tmax

    Time of Maximum Drug ConcentrationTime to Maximum aentration

    Measured: Through study completion, an average of 29 days

  4. TEAE

    Treatment Emergent Adverse Event

    Measured: through study completion, an average of 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start20 Oct 2025
  3. Primary completion14 Jul 2026 (estimated)
  4. Study completion4 Nov 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07193147
Sponsor's protocol ID
GZR4-T2D-105
Status last verified
Nov 2025
First submitted
18 Sep 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GZR4 in people with Diabetes, 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 28 Nov 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: through study completion, an average of 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07193147.

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 28 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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