[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangdong Raynovent Biotech Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,64,80,102,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100628334","phase-1-a-mass-balance-study-of-14c-ray1225-injection-in-healthy-chinese-participants-100628334",false,"NCT07460284","A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants","A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants","Inclusion Criteria:\n\n1. Participants who sign the informed consent form, fully understand the content, process, and possible adverse reactions of the study, and are able to complete the study as required by the study protocol;\n2. Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);\n3. Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)\u002Fheight2 (m 2) between 20.0-35.0 kg\u002Fm2 (inclusive);\n4. Participants (including partners) who agree to voluntarily use effective contraception from screening until 6 months after the investigational drug administration and have no sperm donation plan. For specific contraceptive measures\n\nExclusion Criteria:\n\n1. Subjects with trauma, surgical scar, or skin lesions at the proposed administration site (abdomen) who are not suitable for subcutaneous injection as assessed by the investigator;\n2. History of hypoglycemic episodes within 12 months prior to screening;\n3. Major surgery or serious infection within 12 weeks prior to screening;\n4. Acute disease from the signing of the ICF to the administration of the investigational drug;\n5. Smoking more than 5 cigarettes per day within 12 weeks prior to screening, or unable to abstain from smoking within 7 days prior to admission and during the study;\n6. Participants who are not otherwise eligible to participate in this study.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is an open-label, single-center, single-dose study.",[28],"Basic Science","NOT_YET_RECRUITING","2026-03-03",{"date":32,"type":33},"2026-03-10","ACTUAL",{"date":35,"type":22},"2026-03-15",{"date":37,"type":22},"2026-10-28",{"name":39,"class":40},"Guangdong Raynovent Biotech Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100603671","phase-3-a-study-of-ray1225-versus-semaglutide-as-add-on-therapy-to-oral-antidiabetic-drugs-in-participants-with-type-2-diabetes-100603671","NCT07139548","A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes","A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n1. Have been diagnosed with type 2 diabetes mellitus (T2DM)\n2. Have HbA1c between ≥7.0% and ≤11.5%\n3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg\u002Fm²) at screening\n4. Be of stable weight (±5%) for at least 12 weeks before screening\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus\n2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;\n3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;\n4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \\\u003C3.0 mmol\u002FL) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;\n5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;\n6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation\u002Floss ≥400 mL within 12 weeks prior to screening, or blood donation\u002Floss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);\n7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).",{"count":50,"type":22},600,[52],"PHASE3","The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.",[55],"T2DM","2025-08-17",{"date":58,"type":33},"2025-08-24",{"date":60,"type":22},"2025-08-31",{"date":62,"type":22},"2026-12-31",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":79,"locationsCount":41},"100603670","phase-3-a-study-of-ray1225-in-participants-with-type-2-diabetes-not-controlled-with-diet-and-exercise-alone-100603670","NCT07139535","A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone","A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone","Inclusion Criteria:\n\n1. Have been diagnosed with type 2 diabetes mellitus (T2DM)\n2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.\n3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg\u002Fm²) at screening\n4. Be of stable weight (±5%) for at least 12 weeks before screening\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus\n2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;\n3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;\n4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \\\u003C3.0 mmol\u002FL) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;\n5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;\n6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation\u002Floss ≥400 mL within 12 weeks prior to screening, or blood donation\u002Floss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);\n7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).",{"count":72,"type":22},350,[52],"The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.",[55],{"date":58,"type":33},{"date":60,"type":22},{"date":62,"type":22},{"name":39,"class":40},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":41},"100584720","phase-3-evaluation-of-ray1225-in-adult-participants-who-have-obesity-or-are-overweight-100584720","NCT06893016","Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants Who Have Obesity or Are Overweight","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Body mass index ≥ 28 kg\u002Fm2 or ≥24kg\u002Fm² to \\\u003C28 kg\u002Fm2 with at least 1 of the following weight-related comorbidities: a) Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol\u002FL, fasting low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol\u002FL, fasting high-density lipoprotein cholesterol (HDL-C) \\\u003C1.04 mmol\u002FL, or the need for at least one lipid-lowering treatment to maintain normal lipid levels; c) Obstructive sleep apnea syndrome; d) Fatty liver; e) Cardiovascular disease; e) Polycystic ovary syndrome.\n3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.\n\nExclusion Criteria:\n\n1. Obesity known to be caused by monogenic mutations, other diseases, or medications.\n2. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.\n3. A history of moderate to severe depression at any time in the past or a score of ≥15 on the PHQ-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders.\n4. A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.\n5. Plans to quit smoking during the study period\n6. Allergic constitution (allergic to multiple medications or foods), or those known to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.",{"count":88,"type":22},640,[52],"The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.",[92],"Obesity","RECRUITING","2025-07-15",{"date":96,"type":33},"2025-07-17",{"date":98,"type":33},"2025-06-15",{"date":100,"type":22},"2026-09-15",{"name":39,"class":40},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":41},"100560459","phase-1-a-study-of-ray1225-in-participants-with-impaired-liver-function-100560459","NCT06577415","A Study of RAY1225 in Participants With Impaired Liver Function","A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment","Inclusion Criteria:\n\n1. Participant must be ≥ 18 to ≤ 75 years;\n2. BMI ≥ 20 kg\u002Fm2 up to ≤ 32 kg\u002Fm2;\n3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;\n4. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;\n5. eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2;\n\n   Participants with Normal Hepatic Function Only:\n6. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;\n\n   Participants with hepatic impairment only:\n7. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.\n\nExclusion Criteria:\n\n1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;\n2. QTcF\\> 450ms;\n3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;\n4. Participates who donated blood or bleeding profusely (\\> 400 mL) in the 3 months;\n5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;\n6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;\n7. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;\n\n   Participants with Normal Hepatic Function Only:\n8. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.\n\n   Participants with Hepatic Impairment Only:\n9. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.\n10. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.","75 Years",{"count":111,"type":22},24,[25],"The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.",[115],"Hepatic Impairment","2025-03-18",{"date":118,"type":33},"2025-03-19",{"date":120,"type":33},"2024-08-26",{"date":122,"type":22},"2025-11-15",{"name":39,"class":40},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":41},"100535625","phase-2-a-study-of-ray1225-in-participants-with-obesity-100535625","NCT06254261","A Study of RAY1225 in Participants With Obesity","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity","Inclusion Criteria:\n\n1. Have a body mass index (BMI) of ≥28 kilogram per square meter (kg\u002Fm²) or ≥24 kg\u002Fm² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and \\\u003C 6.5%;\n2. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity\n2. with a history of diabetes or hypoglycemia;\n3. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.\n4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)\n5. allergic constitution;\n6. not suitable for subcutaneous injection.","70 Years",{"count":133,"type":22},270,[135],"PHASE2","The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.",[92],{"date":118,"type":33},{"date":140,"type":33},"2024-02-21",{"date":142,"type":22},"2025-12-20",{"name":39,"class":40},""]