[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chendu DIAO Pharmaceutical Group CO., LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"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},"100651087","a-study-to-evaluate-the-efficacy-and-safety-of-da-302168s-tablets-in-subjects-with-type-2-diabetes-100651087",false,"NCT07755150","A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes","A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study Assessing the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes Mellitus.","Key Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive), both sexes.\n2. Diagnosed with T2DM according to the Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition) for at least 3 months at screening, and meeting one of the following: (1) on stable metformin monotherapy for ≥8 weeks prior to screening, with a daily dose of ≥1500 mg\u002Fday or maximum tolerated dose ≥1000 mg\u002Fday, in addition to diet and exercise; stable treatment defined as no change in daily dose; (2) glycemic control by diet and exercise alone for ≥8 weeks prior to screening.\n3. HbA1c (local laboratory) ≥7.5% and ≤11.0% at screening; and HbA1c (central laboratory) ≥7.5% and ≤10.5% at randomization.\n4. BMI 22.5-40 kg\u002Fm² (inclusive), and stable body weight for 3 months prior to screening (weight change \\\u003C5%, calculated as \\[max weight - min weight\\] \u002F max weight × 100%).\n\nKey Exclusion Criteria:\n\n1. History of type 1 diabetes, diabetes due to pancreatic injury, or other types of diabetes (excluding gestational diabetes) other than T2DM.\n2. Acute diabetic complications (e.g., diabetic ketoacidosis, lactic acidosis, or hyperosmolar nonketotic coma) within 6 months prior to ICF signing; history of grade 3 hypoglycemia within 6 months prior to ICF signing, or ≥3 episodes of hypoglycemia (blood glucose \\\u003C3.9 mmol\u002FL) from 1 month before screening to randomization.\n3. Clinically significant active infection or other diseases (including but not limited to neurological, psychiatric, cardiovascular, endocrine, digestive, respiratory, urinary, hematological, or immunological disorders, except those related to T2DM) within 6 months prior to screening that, in the investigator's judgment, may interfere with trial results or pose additional risks with study drug administration.\n4. Endocrine diseases or history that may significantly affect body weight (e.g., Cushing's syndrome, obesity due to pituitary or hypothalamic disorders), or obesity due to monogenic mutations or genetic obesity syndromes.\n5. Evidence of significant active autoimmune abnormalities (e.g., lupus or rheumatoid arthritis) requiring systemic glucocorticoid therapy during the trial, as judged by the investigator.\n6. Severe chronic diabetic complications at screening (e.g., proliferative retinopathy or maculopathy, painful diabetic neuropathy, intermittent claudication, or diabetic foot).\n7. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2.\n8. Hyperthyroidism (including clinical and subclinical) at screening, or hypothyroidism not controlled with stable medication dose (defined as stable dose for ≥3 months with normal thyroid function tests) based on local laboratory reference ranges.\n9. History of acute pancreatitis, or prior chronic pancreatitis or pancreatic injury, or other high-risk factors for pancreatitis.\n10. Acute cholecystitis within 3 months prior to ICF signing, or presence of cholecystitis\u002Fcholangitis\u002Fbile duct stones\u002Fmultiple gallstones at screening, or gallbladder-related conditions at screening that, in the investigator's judgment, may predispose to cholecystitis (except those who have undergone cholecystectomy and are deemed eligible by the investigator).\n11. Dysphagia or history of gastrointestinal disorders affecting drug absorption, including but not limited to gastrectomy or resection of any intestinal segment, severe gastrointestinal disease, or clinically evident gastric emptying abnormalities.\n12. Uncontrolled or unstable hypertension at screening, defined as SBP ≥160 mmHg and\u002For DBP ≥100 mmHg despite regular antihypertensive treatment, or evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension).\n13. Clinically significant cardiovascular or cerebrovascular diseases, including but not limited to the following events within 6 months prior to ICF signing or during the run-in period: a. unstable angina; b. heart failure (NYHA class III or IV); c. myocardial infarction; d. coronary artery bypass grafting or percutaneous coronary intervention; e. uncontrolled severe arrhythmias, such as sick sinus syndrome, second- or third-degree atrioventricular block; f. cerebrovascular accidents, such as cerebral infarction or transient ischemic attack.\n14. Hemoglobinopathies or anemia, such as hemolytic anemia or sickle cell anemia.\n15. History of moderate or severe depression, or PHQ-9 score ≥15 at screening (see Appendix 2), or psychiatric disorders that, in the investigator's opinion, may affect participation.\n16. Electrocardiogram abnormalities during screening or run-in: heart rate \\\u003C50 bpm or \\>100 bpm; QTcF (Fridericia-corrected) \\>450 ms (male) or \\>470 ms (female).","ALL","18 Years","75 Years",{"count":20,"type":21},272,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide dose-selection evidence for the Phase III confirmatory trial.",[27],"Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2026-08-05",{"date":31,"type":32},"2026-08-10","ACTUAL",{"date":34,"type":21},"2026-08-30",{"date":36,"type":21},"2027-10-20",{"name":38,"class":39},"Chendu DIAO Pharmaceutical Group CO., LTD.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100638870","phase-3-a-study-of-da-302168s-in-participants-with-overweightobesity-100638870","NCT07629544","A Study of DA-302168S in Participants With Overweight\u002FObesity","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight\u002FObese Participants","PANDA-1","Key Inclusion Criteria:\n\n1. Age 18-75 years (inclusive), both males and females;\n2. BMI requirements at screening: for obese participants, BMI ≥28 kg\u002Fm² with or without comorbidities; or for overweight participants, BMI ≥24.0 kg\u002Fm² and \\\u003C28 kg\u002Fm² with at least one of the following comorbidities: hypertension, prediabetes, dyslipidemia, weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases), obstructive sleep apnea syndrome, or metabolic dysfunction-associated steatotic liver disease;\n3. Body weight change \\\u003C5% (based on participant self-report, calculated as \\[maximum weight - minimum weight\\] \u002F maximum weight, with the result rounded to one significant digit) during the 3 months prior to screening, while on diet and exercise control (based on participant self-report).\n\nExclusion Criteria:\n\n1. Type 1 diabetes, type 2 diabetes, or other specific types of diabetes (excluding gestational diabetes);\n2. Secondary obesity, history of bariatric surgery;\n3. Presence of gastrointestinal diseases affecting drug absorption, dysphagia;\n4. Personal\u002Ffamily history of medullary thyroid carcinoma, C-cell hyperplasia, or multiple endocrine neoplasia type 2; uncontrolled hyperthyroidism or hypothyroidism without standard stable management; thyroid nodule with TI-RADS grade 4 or above;\n5. History of acute pancreatitis, chronic pancreatitis, or pancreatic injury within 6 months prior to screening (high-risk pancreatic conditions); acute cholecystitis within the past 3 months, or current cholecystitis, cholangitis, cholelithiasis, or other high-risk gallbladder diseases (except for those with prior cholecystectomy and judged eligible by the investigator);\n6. Severe unstable psychiatric disorder, depression, or history of suicide attempt; score ≥15 on the Patient Health Questionnaire-9 (PHQ-9) at screening, or presence of suicidal ideation\u002Fsuicidal behavior indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS);\n7. Any of the following abnormal clinical laboratory results (local laboratory) at screening: anemia (hemoglobin \\\u003C110 g\u002FL for males, \\\u003C100 g\u002FL for females); liver enzymes, bilirubin, amylase, or lipase exceeding the specified multiples of the upper limit of normal; calcitonin ≥50 ng\u002FL (pg\u002FmL); estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²; triglycerides \\>5.65 mmol\u002FL; thyroid-stimulating hormone \\>6 mIU\u002FL or \\\u003C0.4 mIU\u002FL;\n8. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n9. Abnormal heart rate on resting electrocardiogram, atrioventricular block, prolonged QTcF interval, bundle branch block, or other clinically significant arrhythmias; history of myocardial infarction, unstable angina, severe cardiac insufficiency, coronary intervention\u002Fbypass, or other cardiovascular\u002Fcerebrovascular diseases within 6 months prior to enrollment;\n10. Use of weight-loss drugs or weight-loss herbal medicines, any hypoglycemic agents, antidepressants, antipsychotics, antiepileptics, or lithium salts within 3 months prior to screening; use of systemic glucocorticoids (except for continuous cumulative use \\\u003C7 days); active autoimmune disease requiring systemic glucocorticoid therapy during the study period.",{"count":50,"type":21},840,[52],"PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aimed at evaluating the efficacy, safety, and pharmacokinetic (PK) characteristics of DA-302168S tablets in overweight or obese participants in China.",[55],"Overweight and Obesity","RECRUITING","2026-08-04",{"date":59,"type":32},"2026-08-06",{"date":61,"type":32},"2026-06-19",{"date":63,"type":21},"2027-10-19",{"name":38,"class":39},""]