[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adolescence-obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adolescence-obesity":27},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100646392","phase-1-phase-ib-study-of-efsubaglutide-alfa-injection-in-obese-adolescents-100646392",false,"NCT07693426","Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents","A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Efsubaglutide Alfa in Chinese Adolescents With Obesity","Inclusion Criteria:\n\n* 1\\. Informed consent must be obtained from the participant's parent or legally authorized representative and assent from the adolescent participant before any study-related procedures.\n* 2\\. Adolescent participants aged ≥12 years and \\\u003C18 years (at the time of informed consent).\n* 3\\. At screening, meet the obesity criteria defined in \"WS\u002FT586-2018 Screening for Overweight and Obesity among School-age Children and Adolescents\".\n* 4\\. Before screening, have been on dietary and exercise control alone for at least 3 months with \\\u003C5.0% reduction in body mass index (based on self-report or report by parent or legally authorized representative).\n* 5.Must be willing to follow the diet and exercise guidance and able to maintain such stable diet and exercise lifestyle during the study period.\n* 6\\. Female participants of childbearing potential must have a negative serum pregnancy test at screening.\n* 7\\. Able to understand all study procedures, willing to strictly comply with the study protocol, complete the study visits as scheduled, and finish the study.\n\nExclusion Criteria:\n\n* 1\\. Pre-pubertal participants (Tanner Stage I).\n* 2\\. History of severe allergic reactions or suspected allergy to study drug or its ingredients.\n* 3\\. Pregnant or lactating women; men or women of childbearing potential planning pregnancy or unwilling to use highly effective contraception throughout the study.\n* 4\\. Use of weight-affecting medications before screening.\n* 5\\. Known monogenic obesity, obesity caused by other diseases or medications,\n* 6\\. Previously diagnosed Type 1 diabetes, Type 2 diabetes, or special types of diabetes;\n* 7\\. history of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥2 times within half a year).\n* 8\\. Clinically significant gastric emptying abnormalities, severe chronic gastrointestinal diseases, long-term use of medications directly affecting gastrointestinal motility, or gastrointestinal surgery within 6 months prior to screening, deemed unsuitable for the study by the investigator.\n* 9\\. History of malignancy within 5 years prior to screening, excluding clinically cured cervical intraepithelial neoplasia, squamous cell carcinoma, or basal cell carcinoma within 5 years.\n* 10\\. Major surgery within 6 months prior to screening, or planned surgery during the study that may affect study completion or compliance;\n* 11\\. history of bariatric surgery or planned bariatric surgery during the study (e.g., gastric bypass, gastric banding).\n* 12\\. History of acute or chronic pancreatitis, symptomatic gallbladder disease at screening, history of pancreatic injury, or other high-risk factors for pancreatitis; or amylase or lipase \\>2.0×ULN at screening.\n* 13\\. Known or suspected drug\u002Fsubstance abuse at screening; positive HBsAg;\n* 14\\. Positive HCV antibody with HCV RNA above the lower limit of detection; positive HIV antibody; positive Tp-Ab.\n* 15\\. Currently receiving or received chronic (\\>14 days) systemic glucocorticoid therapy within 3 months prior to screening, or evidence of severe active autoimmune disease that may require systemic glucocorticoid therapy within the next 12 months as judged by the investigator.\n* 16\\. History of hyperthyroidism or hypothyroidism, or TSH \\\u003C1.0×LLN, or TSH \\>1.5×ULN, or history of medullary thyroid carcinoma.\n* 17\\. Serum calcitonin ≥50 ng\u002FL (pg\u002FmL) at screening; ALT \\>3.0×ULN, or AST \\>3.0×ULN, or total bilirubin \\>2.0×ULN; eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² at screening; fasting triglycerides ≥5.64 mmol\u002FL (500 mg\u002FdL).\n* 18\\. Blood donation and\u002For blood loss ≥400 mL or bone marrow donation within 3 months prior to screening, or presence of hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin \\\u003C118 g\u002FL (ages 12-\\\u003C13 years), \\\u003C129 g\u002FL (males ≥13 years), or \\\u003C114 g\u002FL (females ≥13 years).\n* 19\\. Participation in vaccine or medical device clinical trials within 3 months prior to screening, or any drug clinical trial within less than 3 months or 5 half-lives (whichever is longer).\n* 20\\. History of moderate to severe depression, anxiety disorder, or severe psychiatric illness.\n* 21\\. Any other condition that, in the opinion of the investigator, may affect the participant's safety or compliance with the study protocol.","ALL","12 Years","17 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity.",[27],"Adolescence Obesity",[29,30,31,32],"Efsubaglutide Alfa","GLP-1 receptor agonist","Adolescent Obesity","weight loss","RECRUITING","2026-07-29",{"date":36,"type":37},"2026-07-30","ACTUAL",{"date":39,"type":37},"2026-07-16",{"date":41,"type":21},"2027-08-31",{"name":43,"class":44},"Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.","OTHER",5]