[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gan and Lee Pharmaceuticals, USA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,64,85,107],{"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},"100611598","phase-1-clamp-study-to-estimate-the-relative-potency-of-gzr33-versus-insulin-degludec-at-steady-state-100611598",false,"NCT07242664","Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State","A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared With Insulin Degludec at Steady State in Participants With Type 1 Diabetes","Inclusion Criteria: type 1 diabetes for at least 12 months\n\n* 18-64 years of age\n* HbA1c \\\u003C= 9.0%.\n* Body Mass Index (BMI) between 18.5 and 29.0 kg\u002Fm\\^2\n* treated with a stable insulin regimen for at least 2 months, in a dose \\> 0.2 and \\\u003C 1.2 U\u002Fkg\u002Fday\n\nExclusion Criteria:\n\n* blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic)\n* clinically significant concomitant diseases\n* recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening)\n* hypoglycemia unawareness\n* estimated glomerular filtration rate (eGFR) \\\u003C60.0 mL\u002Fmin\u002F1.73 m2","ALL","18 Years","64 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.",[27],"Type 1 Diabetes Mellitis","RECRUITING","2025-11-17",{"date":31,"type":32},"2025-11-21","ACTUAL",{"date":34,"type":32},"2025-10-13",{"date":36,"type":21},"2026-04-15",{"name":38,"class":39},"Gan and Lee Pharmaceuticals, USA","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100604194","phase-1-comparison-study-of-insulin-gzr4-with-insulin-degludec-100604194","NCT07146347","Comparison Study of Insulin GZR4 With Insulin Degludec","A Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared With Insulin Degludec and Insulin Icodec in Participants With Type 2 Diabetes","Inclusion Criteria:\n\nSigned and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant. 2. Male or female person with type 2 diabetes mellitus. 3. Age between 18 and 70 years, both inclusive. 4. Body Mass Index (BMI) between 27.0 and 38.0 kg\u002Fm\\^2, both inclusive. 5. Diabetes duration of at least 12 months. 6. Stable basal insulin regimen for at least 3 months. 7. Total daily basal insulin dose between 0.2-0.7 (I)U\u002Fkg\u002Fday, both inclusive. 8. HbA1c \\\u003C= 9.0%. 9. Have venous access sufficient to allow cannulation for blood sampling as required by the protocol.\n\nExclusion Criteria:\n\nKnown or suspected hypersensitivity to IMPs or any of the excipients or to any component of the IMP formulations. 2. Previous participation in this trial. Participation is defined as randomized at Visit 2.\n\n3\\. Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial. 4. Use of insulin icodec as basal insulin. 5. History of multiple and\u002For severe allergies to drugs or foods or a history of severe anaphylactic reaction. 6. Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator during the last 5 years prior to screening. 7. Clinically relevant comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data. Signs of acute illness as judged by the investigator. 9. Any serious systemic infectious disease during four weeks before randomization in this trial, as judged by the investigator. 10. Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis as judged by the investigator. 11. Estimated glomerular filtration rate (eGFR) \\\u003C 60.0 mL\u002Fmin\u002F1.73m2. 12. Systolic blood pressure \\\u003C 90 mmHg or \\>159 mmHg and\u002For diastolic blood pressure \\\u003C 50 mmHg or \\> 99 mmHg at screening (one repeat test will be acceptable in case of suspected white-coat hypertension). 13. Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute at screening. This exclusion criterion also applies to participants who are on anti-hypertensives. 14. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in a supine position at screening, as judged by the investigator. 15. Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\\\u003C1.5 years) ophthalmologic examination. 16. Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.\n\n17\\. Recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening). 18. Hypoglycemic unawareness as judged by the investigator. 19. Hospitalization for diabetic ketoacidosis during the previous 6 months. 20. Use of oral antidiabetic drugs (OADs) within 1 month or 5 half-times (whichever is longer) prior to screening with the exception of stable doses (for at least 3 months prior to screening) of metformin, DPP4, SGLT2 inhibitors and GLP-1 receptor agonists. 21. Increased risk of thrombosis, e.g. participants with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator. 22. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol\u002Fday (for males), 12.0 grams alcohol\u002Fday (for females) on average. 23. A positive result in the alcohol and\u002For urine drug screen at the screening visit.\n\n24\\. Smoking more than 5 cigarettes or the equivalent per day. 25. Inability or unwillingness to refrain from smoking and use of nicotine substitute products during the inpatient period Tested positive for hepatitis Bs antigen. 27. Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal, and a hepatitis C polymerase chain reaction is negative). 28. Positive result to the test for HIV-1\u002F2 antibodies or HIV-1 antigen. 29. Current treatment with systemically effective corticosteroids, monoamine oxidase inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products. 30. Use of non-prescription medication, including herbal products and non-routine vitamins, within 2 weeks prior screening that will interfere with PK of GZR4, insulin degludec or insulin icodec, as judged by the investigator. 31. Blood donation or blood loss of more than 500 mL within the last 3 months before screening.\n\n32\\. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 33. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 34. If female, pregnancy or breast-feeding. 35. Women of childbearing potential who are not using a highly effective contraceptive method.\n\n36\\. Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method during trial participation. 37. The investigator considers a person as unsuitable for inclusion in the trial for any other reason.","70 Years",{"count":50,"type":21},14,[24],"In this study, the investigational product will be compared with insulin degludec (Tresiba®) and insulin icodec (Awiqli®). The comparator products are approved for the treatment of T2DM in the European Union.",[54],"Type 2 Diabetes","2025-08-22",{"date":57,"type":32},"2025-08-28",{"date":59,"type":32},"2025-08-15",{"date":61,"type":21},"2026-06-01",{"name":38,"class":39},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100567593","phase-1-a-phase-i-clinical-study-to-evaluate-the-effect-of-gzr18-injection-on-the-pharmacokinetics-of-oral-metformin-hydrochloride-tablets-in-overweightobese-subjects-100567593","NCT06670209","A Phase I Clinical Study to Evaluate the Effect of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochloride Tablets in Overweight\u002FObese Subjects","A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Repeated Subcutaneous Injections of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochloride Tablets in Overweight\u002FObese Subjects","Inclusion Criteria:\n\n* Overweight\u002Fobese Chinese subjects, who voluntarily sign the Informed Consent Form (ICF), can receive subcutaneous injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.\n* Male or female, 18 to 50 years of age at signing the ICF (both inclusive).\n* Weight ≥ 50 kg and body mass index (BMI) within 24-33 kg\u002Fm2 (both ends inclusive) at screening.\n* Subjects of childbearing potential with no birth plan from the signing of ICF to 3 months after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (prior to enrollment).\n\nExclusion Criteria:\n\n* Subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disease, malignant tumor and other diseases that are judged by the investigator to have an impact on pharmacokinetics and safety evaluation.\n* History or existing diseases that increase the risk of subjects, such as hypoglycaemia, acute or chronic pancreatitis, pancreatic injury, history of symptomatic gallbladder disease; cholelithiasis with high risk of acute biliary pancreatitis at screening (e.g., silt-like lithiasis, gallbladder ≤ 5 mm in diameter and bile duct stone, etc.).\n* Subjects with previous or existing diseases that significantly affect drug absorption, metabolism or excretion, such as history of active peptic ulcer or haemorrhage, inflammatory bowel disease, abnormal gastric emptying (such as gastric paresis or pyloric stenosis, gastric outlet obstruction), long-term use (continuous for ≥ 1 week) of drugs that affect gastrointestinal motility (including but not limited to domperidone, mosapride, macrolides).\n* Subjects with severe infection or unexplained infection within 4 weeks before screening.\n* Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.\n* History of drug abuse prior to screening; or positive results for drug abuse at screening.\n* Subjects who used nicotine-containing products within 3 months prior to screening or are screened positive for nicotine in urine.\n* Other factors that make subjects unqualified to participate in this trial as judged by the Investigator.","50 Years",{"count":73,"type":21},32,[24],"This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of multiple subcutaneous injections of GZR18 Injection on the pharmacokinetics of multiple oral doses of metformin hydrochloride tablets.",[54],"NOT_YET_RECRUITING","2024-10-30",{"date":80,"type":32},"2024-11-01",{"date":78,"type":21},{"date":83,"type":21},"2025-03-19",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":63},"100559021","phase-2-a-trial-comparing-efficacy-tolerability-and-safety-of-gzr101-injection-once-daily-od-and-gzr33-70-injection-od-100559021","NCT06558708","A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD","A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin","Inclusion Criteria:\n\n* 1\\. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.\n* 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.\n* 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.\n* 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.\n\nExclusion Criteria:\n\n* 1.Presence or history of malignant neoplasm prior to screening.\n* 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.\n* 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.\n* 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.\n* 5\\. Participated in another interventional clinical study within 4 weeks prior to randomization.","75 Years",{"count":94,"type":21},60,[96],"PHASE2","This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal\u002F premixed insulin once daily at least with or without pre-dinner meal-time insulin.",[54],"2024-08-14",{"date":101,"type":32},"2024-08-19",{"date":103,"type":32},"2024-06-28",{"date":105,"type":21},"2024-12",{"name":38,"class":39},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":115,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":63},"100558268","phase-1-a-study-of-gzr4-injection-at-different-injection-sites-100558268","NCT06548906","A Study of GZR4 Injection at Different Injection Sites","A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects","Inclusion Criteria:\n\n* 1\\. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.\n* 2\\. A Male adult subjects aged 18-55 years old.\n* 3\\. Body mass index (BMI) between 19.0-24.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* 1\\. Known or suspected hypersensitivity to investigational medical product(s) or related products.\n* 2\\. Participation in a clinical study of another study drug within 3 months prior to randomization.\n* 3\\. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.\n* 4\\. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening\n* 5\\. More than 14 units of alcohol per week within 3 months prior to randomization\n* 6\\. Smoking more than 5 cigarettes per day within 3 months prior to randomization",true,"MALE","55 Years",{"count":118,"type":21},24,[24],"This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).",[122],"Healthy Subjects","2024-08-08",{"date":125,"type":32},"2024-08-12",{"date":127,"type":32},"2024-05-08",{"date":129,"type":21},"2024-08-31",{"name":38,"class":39},""]