New diabetes drug tested in patients with liver problems
NCT ID NCT07193147
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how a single dose of the experimental drug GZR4 injection behaves in people with mild, moderate, or severe liver impairment compared to those with normal liver function. The goal is to understand the drug's safety and how the body processes it. 36 adults with diabetes and varying liver health will participate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be included in the study. 1. Subjects must fully understand the study contents, study procedures and possible risks and voluntarily sign the informed consent form; 2. Male or female subjects aged ≥ 18 years and ≤ 75 years; 3. 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. 4. Only for Subjects with Hepatic Impairment: Subjects with chronic hepatic impairment caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other reasons; 5. Only for Subjects with Hepatic Impairment: Subjects with a prior diagnosis of hepatic cirrhosis confirmed through liver biopsy or other medical imaging techniques; 6. 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; 7. 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. Exclusion Criteria: * Subjects who meet any of the following criteria should not be enrolled in this study. 1. 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); 2. 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; 3. 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; 4. 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; 5. 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; 6. 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; 7. 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; 8. 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. 9. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Gan & Lee Pharmaceuticals Shandong Co., Ltd.
Linyi, Shandong, 276000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New pill takes aim at blood sugar in diabetes
- Home c-peptide tests could reveal hidden insulin production in diabetes
- Brain scans may predict who is most at risk for dangerous low blood sugar
- Diabetes devices put to the test: can home monitors match lab accuracy?
- Liver trouble changes how drugs work: scientists test soticlestat
- Can weekly groceries and group coaching help control diabetes?