[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638047":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":26,"locations":22,"responsibleParty":32,"collaborators":22,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":22,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":22,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":22,"overallStatus":53,"whyStopped":22,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":22},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"SYHX2008","EXPERIMENTAL",[12],"Drug: SYHX2008",{"label":14,"type":10,"description":14,"interventionNames":15},"Sandostatin LAR®",[16],"Drug: Sandostatin LAR®",[18,23],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.",[9],null,{"type":19,"name":14,"description":24,"armGroupLabels":25,"otherNames":22},"The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.",[14],[27],{"name":28,"role":29,"phone":30,"phoneExt":22,"email":31},"Clinical Trials Information Group officer","CONTACT","+86311-69085587","ctr-contact@cspc.cn",{"type":33,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100638047","phase-3-a-phase-iii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-octreotide-long-acting-injection-in-patients-with-acromegaly-100638047",false,"NCT07623824","A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly","A Randomized, Parallel, Open-label, Multicenter, Positive-controlled, Superiority Phase III Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly","Inclusion Criteria:\n\n* Male or female participants aged 18 to 80 years (including boundary values)\n* Diagnosed with acromegaly, currently in the active stage of the disease (for patients who have not undergone pituitary tumor surgery before, MRI shows a pituitary mass, fasting GH ≥ 2.5 ng\u002FmL and IGF-1 index ≥ 1.3; for patients who have undergone pituitary tumor surgery, fasting GH ≥ 2.5 ng\u002FmL and IGF-1 index ≥ 1.3)；\n\nExclusion Criteria:\n\n* Have received pituitary radiotherapy within the 5 years prior to screening\n* Have undergone major surgery (including pituitary surgery) within 6 months prior to screening or are expected to require surgery (including pituitary surgery) or radiotherapy during the study period\n* Within three months before the screening, participants received drugs such as long-acting lanretide, long-acting octreotide, pervesomone, and cabergoline, or traditional Chinese medicines for treating acromegaly. Receive bromocriptine within one month before screening; Received short-acting octreotide or lanretide short-acting preparations for treatment within 7 days before screening; Or have received any other investigational drug within 30 days before screening or within 5 half-lives (whichever is longer)\n* Previous failure to respond to octreotide or lantreotide monotherapy (defined as: after at least 3 months of treatment with octreotide microspheres ≥30 mg or lantreotide ≥120 mg, or after at least 3 months of treatment with parietide microspheres ≥40 mg, random GH ≥2.5 ng\u002FmL and\u002For IGF-1 index ≥1.3) or history of intolerance.\n* Participants with obvious visual field defects caused by optic chiasm compression and requiring surgical intervention\n* HbA1c\\>8.5%","ALL","18 Years","80 Years",{"count":45,"type":46},154,"ESTIMATED","INTERVENTIONAL",[49],"PHASE3","he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.",[52],"Diagnosed With Acromegaly, Currently in the Active Stage of the Disease","NOT_YET_RECRUITING","2026-05-29",{"date":56,"type":57},"2026-06-03","ACTUAL",{"date":59,"type":46},"2026-05-31",{"date":61,"type":46},"2029-12-30",{"name":5,"class":6}]