[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obesityoverweight\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obesityoverweight":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100603785","phase-1-study-of-pharmacokinetics-and-safety-of-gzr18-injection-in-subjects-with-renal-impairment-and-normal-renal-function-100603785",false,"NCT07141030","Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function","To Assess the Pharmacokinetic (PK) Differences of GZR18 Injection Between Subjects With Renal Impairment and Those With Normal Renal Function, Providing a Basis for Establishing a Clinical Dosing Regimen for Patients With Renal Impairment","Inclusion Criteria:\n\n* 1.Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.\n\n  2.Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing ICF.\n\n  3.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; 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.\n\n  4.Subjects weighing ≥ 50 kg and 20 ≤ BMI ≤ 40 kg\u002Fm2 at screening.\n\n  5.Subjects with normal renal function must also meet the following conditions:\n  1. 90 mL\u002Fmin ≤ individual's GFR \\\u003C 130 mL\u002Fmin at screening (see Appendix 2: Formulas Involved in the Protocol for the calculation formula).\n  2. Subjects with normal laboratory test results, vital signs, ECG, physical examination, chest AP view, abdominal B-ultrasound, and other examination results at screening or without clinically significant abnormalities as assessed by the investigator.\n\n  6.Subjects with renal impairment must also meet all of the following:\n  1. Mild renal impairment group: 60 mL\u002Fmin ≤ individual's GFR \\\u003C 90 mL\u002Fmin at screening; moderate renal impairment group: 30 mL\u002Fmin ≤ individual's GFR \\\u003C 60 mL\u002Fmin at screening; severe renal impairment group: 15 mL\u002Fmin ≤ individual's GFR \\\u003C 30 mL\u002Fmin at screening.\n  2. Subjects with moderate and severe renal impairment should meet the diagnostic criteria for chronic kidney disease (outpatient medical records, hospitalization medical records or laboratory test results can be used as evidence). If the subject is receiving drug therapy, a stable medication regimen (at least within 2 weeks before administration) is required.\n\n     Exclusion Criteria:\n* 1.Subjects with allergic constitution, including those with a history of severe drug allergy or hypersensitivity reactions, and those known or suspected to be allergic to GLP-1 drugs or their excipients as considered by the investigator.\n\n  2.Subjects with a history of acute or chronic pancreatitis and pancreatic injury before screening; subjects with viral hepatitis, alcoholic liver disease, hepatic cirrhosis, autoimmune hepatitis and other liver diseases before screening; subjects with symptomatic gallbladder disease at screening.\n\n  3.Subjects who routinely receive dialysis or have a history of kidney transplantation or other organ transplantation before screening.\n\n  4.Subjects with severe infection, severe trauma, gastrointestinal surgery, or other major surgical operations within 6 months before screening.\n\n  5.Subjects with a history of moderate or major depression, suicidal tendency or suicidal behavior before screening; or other serious mental disorders (schizophrenia, bipolar affective disorder, etc.); or other psychiatric diseases that the investigator considers inappropriate for this study.\n\n  6\\. Subjects with a history of drug abuse or drug use within 1 year before screening; or subjects with positive result in a drug abuse screening (urine) (which cannot be justified by concurrent medications, such as those used for treating pain, anxiety, or insomnia as complications of renal disorder) at screening.\n\n  7.Subjects who have received a vaccine within 2 weeks before screening or are planning to be vaccinated during the study or within 1 month postdose.\n\n  8.Subjects who are positive for any indicator of human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening.\n\n  9.Subjects deemed unsuitable for inclusion by the investigator for other reasons.","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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 renal function and those with mild, moderate or severe renal impairment.\n\nThe 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\u002Fobservation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).",[27],"Obesity\u002FOverweight","RECRUITING","2025-11-20",{"date":31,"type":32},"2025-11-21","ACTUAL",{"date":34,"type":32},"2025-04-11",{"date":36,"type":21},"2026-03-31",{"name":38,"class":39},"Gan & Lee Pharmaceuticals.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":40},"100604021","phase-1-study-of-pharmacokinetics-and-safety-of-gzr18-injection-in-subjects-with-liver-insufficiency-and-normal-liver-function-100604021","NCT07144098","Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function","Inclusion Criteria:\n\n* All Subjects:\n\n  1. 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.\n  2. Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing the ICF.\n  3. Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 19.0-32.0 kg\u002Fm2 (both inclusive).\n  4. 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.\n\n     Only for Subjects with Liver Dysfunction:\n  5. 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.\n  6. Determined as grade A, B or C according to the Child-Pugh score, and no albumin was used within 21 days before screening.\n  7. 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.\n\nOnly for Subjects with Normal Liver Function:\n\n1. 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%).\n2. 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.\n\nExclusion Criteria:\n\n* 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).\n\n  2\\. History of acute or chronic pancreatitis and pancreatic injury before screening. Subjects with symptomatic gallbladder disorders at screening.\n\n  3\\. History or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B before screening.\n\n  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.\n\n  5\\. During screening, 12-lead electrocardiogram: QTcF \\> 470 msec (for males) or \\> 480 msec (for females).\n\n  6\\. Those with a history of severe active infection within one month prior to screening.\n\n  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).\n\n  8\\. Subjects with severe trauma, gastrointestinal surgery, or other major surgical operations within 4 weeks before screening.\n\n  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.",true,{"count":49,"type":21},24,[24],"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.\n\nThe 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\u002Fobservation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).",[27],"2025-08-20",{"date":55,"type":32},"2025-08-27",{"date":57,"type":32},"2025-08-12",{"date":59,"type":21},"2027-01-26",{"name":38,"class":39}]