[{"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:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"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":5},"100638870","phase-3-a-study-of-da-302168s-in-participants-with-overweightobesity-100638870",false,"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.","ALL","18 Years","75 Years",{"count":21,"type":22},840,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Overweight and Obesity","NOT_YET_RECRUITING","2026-06-01",{"date":32,"type":33},"2026-06-05","ACTUAL",{"date":35,"type":22},"2026-06-27",{"date":37,"type":22},"2027-10-19",{"name":39,"class":40},"Chendu DIAO Pharmaceutical Group CO., LTD.","INDUSTRY",""]