[{"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:":155},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,64,91,111,131],{"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":76,"conditions":77,"keywords":79,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100572728","phase-2-efficacy-and-safety-of-gzr18-every-2-weeks-versus-tirzepatide-and-placebo-in-obese-or-overweight-participants-100572728","NCT06737042","Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants","EFFICACY and SAFETY of GZR18 INJECTED EVERY 2 WEEKS (Q2W) in PARTICIPANTS WITHOUT TYPE 2 DIABETES, WHO HAVE OBESITY or ARE OVERWEIGHT: a RANDOMIZED, TIRZEPATIDE- and PLACEBO-CONTROLLED STUDY","Inclusion Criteria:\n\n1. 18 to 75 years of age (both inclusive) at the time of signing the informed consent form (ICF).\n2. History of failing to lose sufficient weight with lifestyle\u002Fdietary modification.\n\nBMI ≥30.0 kg\u002Fm2, or\n\nBMI ≥27.0 kg\u002Fm2 with at least 1 of the following:\n\n* Hypertension: defined as taking blood pressure (BP) lowering medication or have a systolic blood pressure (SBP) of ≥130 mmHg or a diastolic blood pressure (DBP) of ≥80 mmHg at screening.\n* Dyslipidemia: defined as taking lipid-lowering medication or have LDL ≥160 mg\u002FdL (4.1 mmol\u002FL) or triglycerides ≥150 mg\u002FdL (1.7 mmol\u002FL), or high-density lipoprotein (HDL) \\\u003C40 mg\u002FdL (1.0 mmol\u002FL) for men or HDL \\\u003C50 mg\u002FdL (1.3 mmol\u002FL) for women at screening.\n* Obstructive sleep apnea.\n* Cardiovascular disease: defined as having eg, ischemic cardiovascular disease or New York Heart Association (NYHA) Functional Classification Class I to II heart failure.\n\n  4\\. In the investigator's opinion, are well motivated, capable, and willing to:\n* Learn how to self-inject the IP as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the IP; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IP).\n* Inject the IP (or receive an injection from a trained individual if visually impaired or with physical limitations).\n* Follow study procedures for the duration of the study, including, but not limited to, lifestyle advice (eg, dietary changes and physical activity plan), complete the electronic diary (eDiary), and complete required questionnaires.\n* Identify the biological sex for the study stratification. 5.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Medical Conditions Related to Obesity\n\n1. A self-reported change (increase or decrease) in body weight \\>5 kg within 3 months prior to screening.\n2. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \\>1 year prior to screening).\n3. Have or plan to have endoscopic and\u002For device-based therapy for obesity or have had device removal within the last 6 months prior to screening, including but not limited to:\n\n   * Mucosal ablation\n   * Gastric artery embolization\n   * Intragastric balloon\n   * Duodenal-jejunal endoluminal liner Related to Diabetes\n4. History of type 1 or T2DM, history of ketoacidosis, or hyperosmolar state\u002Fcoma.\n5. At least 1 laboratory value suggestive of diabetes during screening, including 1 or more of HbA1c ≥6.5% (48 mmol\u002Fmol), fasting serum glucose ≥126 mg\u002FdL (7.0 mmol\u002FL), or random glucose ≥200 mg\u002FdL (11.1 mmol\u002FL).\n\n   Other Medical Conditions\n6. Renal impairment measured as estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2, calculated by chronic kidney disease-epidemiology collaboration (CKD-EPI) as determined by central laboratory during screening.\n7. Known clinically significant gastric emptying abnormality (eg, severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility.\n8. History of acute or chronic pancreatitis. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has a cholecystectomy to resolve the problem.\n9. Thyroid-stimulating hormone (TSH) outside of the range of 0.4 to 6.0 mIU\u002FL at screening.\n\n   Note: Participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months.\n\n   Note: TSH values above the normal range can, in some participant, suggest subclinical hypothyroidism. If, in the investigator's opinion, the participant has subclinical hypothyroidism and may require initiation of thyroid hormone replacement during the study, the participant should be excluded from the study.\n10. Obesity induced by other endocrinologic disorders (eg, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (eg, melanocortin 4 receptor deficiency or Prader-Willi syndrome).\n11. History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.\n\n    Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications.\n12. A history of suicide attempt.\n13. Patient health questionnaire-9 (PHQ-9) score of 15 or more at screening.\n14. On the Columbia Suicide Severity Rating Scale (C-SSRS) prior to randomization:\n\n    * a \"yes\" answer to Question 4 (active suicidal ideation with some intent to act, without specific plan) on the \"suicidal ideation\" portion of the C-SSRS or\n    * a \"yes\" answer to Question 5 (active suicidal ideation with specific plan and intent) on the \"suicidal ideation\" portion of the C-SSRS or\n    * a \"yes\" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the \"suicidal behavior\" portion of the C-SSRS and\n    * the ideation or behavior occurred within the past month\n15. Uncontrolled hypertension (SBP ≥160 mmHg and\u002For DBP ≥100 mmHg). If a participant is on antihypertensive therapies, doses must be stable for 30 days prior to screening. For participants with uncontrolled hypertension at screening, antihypertensive medication may be started or adjusted. BP must meet the protocol criterion for hypertension control with stable treatment for at least 30 days before re-screening.\n16. An elevated resting pulse rate \\>100 bpm at baseline.\n17. Any of the following cardiovascular conditions within 3 months prior to screening:\n\n    * Acute myocardial infarction\n    * Cerebrovascular accident (stroke)\n    * Unstable angina\n    * Hospitalization due to congestive heart failure (CHF)\n18. Ongoing or history of frequent intermittent or chronic tachyarrhythmia syndromes (eg, atrial fibrillation, supraventricular tachycardia, and positional orthostatic tachycardia syndrome).\n\n    Note: Participants with a history of premature atrial contractions or premature ventricular contractions may be included.\n19. NYHA Functional Classification III or IV CHF.\n20. An electrocardiogram (ECG) considered by the investigator indicative of active cardiac disease or with abnormalities that may interfere with the interpretation of changes in ECG intervals at screening.\n21. Acute or chronic hepatitis, or signs and symptoms of any other liver disease other liver disease except nonalcoholic fatty liver disease (NAFLD) (ie, participants with NAFLD are eligible for participation), or any of the following at screening:\n\n    * alanine aminotransferase (ALT) \\>3 × the upper limit of normal (ULN)\n    * alkaline phosphatase (ALP) \\>1.5 × ULN\n    * total bilirubin level \\>1.5 × ULN (except for cases of known Gilbert's Syndrome)\n22. Serum calcitonin level of:\n\n    * 20 ng\u002FL, if eGFR ≥60 mL\u002Fmin\u002F1.73 m2\n    * 35 ng\u002FL, if eGFR ≤60 mL\u002Fmin\u002F1.73 m2\n23. A family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).\n24. A history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \\\u003C5 years.\n25. Any other condition not listed in this section (eg, hypersensitivity or intolerance) that is a contraindication to GLP-1R agonists.\n26. A history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol.\n27. Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n28. A history of use of marijuana or tetrahydrocannabinol (THC)-containing products within 3 months of enrollment or unwillingness to abstain from marijuana or THC-containing product use during the study.\n\n    Note: If a participant has used cannabidiol oil during the past 3 months but agrees to refrain from use for the duration of the study, the participant may be enrolled.\n29. Have had an organ transplant (corneal transplants \\[keratoplasty\\] are allowed) or are awaiting an organ transplant.\n30. Any hematological condition that may interfere with HbA1c measurements (eg,\n31. A blood donation of ≥500 mL within the previous 8 weeks of screening or a blood transfusion or severe blood loss within the prior 3 months, or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or a hemoglobin value \\\u003C11 g\u002FdL (men) or \\\u003C10 g\u002FdL (women), or any other condition known to interfere with HbA1c methodology.\n32. A history of atopy (severe or multiple allergic manifestations) or clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis).\n33. A fasting serum triglyceride level of \\>500 mg\u002FdL at screening. If a participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.\n\n    Prior\u002FConcomitant Therapy\n34. Are receiving or have received within 3 months prior to screening chronic (\\>2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations) or have evidence of a significant, active autoimmune abnormality (eg, lupus or rheumatoid arthritis) that has required (within the last 3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with systemic glucocorticoids (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations) during the course of the study.\n35. Receiving treatment with or have a history of treatment with (within 3 months prior to screening) medications that may cause significant weight gain including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers:\n\n    Examples:\n    * imipramine\n    * amitriptyline\n    * mirtazapine\n    * paroxetine\n    * phenelzine\n    * chlorpromazine\n    * thioridazine\n    * clozapine\n    * olanzapine valproic acid and its derivatives\n    * lithium Note: Selective serotonin reuptake inhibitors other than paroxetine are permitted.\n36. Have taken within 3 months prior to screening medications (prescribed or over thecounter) or alternative remedies intended to promote weight loss.\n\n    Examples include, but are not limited to:\n    * Saxenda® (liraglutide 3.0 mg) or other GLP-1R agonists\n    * Xenical®\u002FAlli® (orlistat)\n    * Meridia® (sibutramine)\n    * Acutrim® (phenylpropanolamine)\n    * Sanorex® (mazindol)\n    * Adipex® or LomairaTM (phentermine)\n    * QsymiaTM (phentermine\u002Ftopiramate combination)\n    * Contrave® (naltrexone\u002Fbupropion)\n37. Use of metformin or any other glucose-lowering medication, whether prescribed for polycystic ovarian syndrome or diabetes prevention is not permitted.\n38. Have started implantable or injectable contraceptives (such as Depo Provera®) within 18 months prior to screening.\n\n    Prior\u002FConcurrent Clinical Study Experience\n39. Have known allergies to GLP-1R agonists or GZR18.\n40. Are currently enrolled in any other clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study.\n41. Within the last 30 days, participated in a clinical study and received treatment, whether active or placebo. If the study involved an IP, 5 half-lives or 30 days, whichever is longer, should have passed.\n42. Have previously completed or withdrawn from this study or any other study investigating GZR18 and have previously received GZR18.\n\n    Other Exclusions\n43. Women of childbearing potential (WOCBP) who:\n\n    * Are pregnant or intend to become pregnant (or have a positive pregnancy test at screening).\n    * Are lactating\u002Fbreastfeeding (including the use of a breast pump).\n    * Are unwilling to remain abstinent or use acceptable birth control","75 Years",{"count":73,"type":21},285,[75],"PHASE2","This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg\u002Fm2) or who are overweight (BMI ≥27 kg\u002Fm2) with weight-related comorbidities (excluding type 2 diabetes mellitus).",[78],"Obesity and Overweight",[80],"GLP-1, Obesity, Overweight, Weight loss","NOT_YET_RECRUITING","2025-02-03",{"date":84,"type":32},"2025-02-04",{"date":86,"type":21},"2025-02-12",{"date":88,"type":21},"2026-06-22",{"name":38,"class":39},20,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"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":100,"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],"2024-10-30",{"date":106,"type":32},"2024-11-01",{"date":104,"type":21},{"date":109,"type":21},"2025-03-19",{"name":38,"class":39},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"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.",{"count":119,"type":21},60,[75],"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":125,"type":32},"2024-08-19",{"date":127,"type":32},"2024-06-28",{"date":129,"type":21},"2024-12",{"name":38,"class":39},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":139,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"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":142,"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).",[146],"Healthy Subjects","2024-08-08",{"date":149,"type":32},"2024-08-12",{"date":151,"type":32},"2024-05-08",{"date":153,"type":21},"2024-08-31",{"name":38,"class":39},""]