[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hasten Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100559771","phase-3-a-study-on-efficacy-and-safety-of-hst101-in-chinese-patients-with-hypercholesterolemia-100559771",false,"NCT06568471","A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia","A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia","Inclusion Criteria:\n\n* Provision of written and signed informed consent form prior to any study-specific procedure;\n* Male or female participants ≥18 years of age at the screening visit;\n* Body weight ≥ 40 kg and body mass index (BMI) ≥18 and ≤35 kg\u002Fm2;\n* On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4 weeks prior to the first drug administration\n* LDL-C≥1.8 mmol\u002FL (70 mg\u002FdL) and TG≤4.52 mmol\u002FL (400 mg\u002FdL) at screening for ASCVD patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH; LDL-C ≥ 2.6 mmol\u002FL (100 mg\u002FdL) and TG ≤ 4.52 mmol\u002FL (400 mg\u002FdL) at screening for patients at high-risk for ASCVD including patients with HeFH;\n* Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥6 weeks after the last dose; for those on 300 mg or 420 mg Q4W, the washout period is ≥10 weeks following last dose;\n* Female of childbearing potential must have a negative pregnancy test at the last screening visit and consent to use highly effective contraceptives during the trial and 3 months after the last dose of investigational drug.\n\nExclusion Criteria:\n\n* Documented history of homozygous familial hypercholesterolemia (HoFH);\n* Estimated glomerular filtration rate (eGFR)\\\u003C30 mL\u002Fmin\u002F1.73m2;\n* Active liver disease or hepatic dysfunction, history of liver transplant, and\u002For ALT or AST \\>2.5 × ULN at screening;\n* Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;\n* Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol\u002FL (200 mg\u002FdL) and glycosylated hemoglobin (HbA1c) ≥ 9%;\n* Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to the first dose;\n* Planned cardiac surgery or revascularization during the study period;\n* New York Heart Association (NYHA) Class III-IV heart failure;\n* Pregnant or lactating women;\n* Poorly controlled hypertension (SBP≥160 mmHg or DBP≥100 mmHg in a sitting position)\n* Unexplained creatine kinase (CK) \\> 5 x ULN (retested once is needed if suspected to be related to excessive exercise or abnormal activity);\n* LDL apheresis or plasma exchange within 2 months prior to the first dose;\n* HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA \\>ULN at screening;\n* History of prescription drug abuse, illicit drug use or alcohol abuse within 6 months prior to screening;\n* History of any major drug allergy, including allergy to protein biologics;\n* Participate another clinical trial within 30 days or less than 5 half-lifes (drug) before screening, whichever is longer","ALL","18 Years",{"count":19,"type":20},210,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \\[≤31 days\\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high\u002Fhigh risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.",[26,27,28,29,30,31,32],"Hypercholesterolemia","Dyslipidemias","Primary Hypercholesterolemia","Heterozygous Familial Hypercholesterolemia","Hyperlipidemia; Mixed","Metabolic Disease","ASCVD",[34,35,36],"PCSK9 inhibitor","Lerodalcibep","LDL-C","RECRUITING","2025-02-04",{"date":40,"type":41},"2025-02-06","ACTUAL",{"date":43,"type":41},"2024-11-16",{"date":45,"type":20},"2026-05",{"name":47,"class":48},"Hasten Biopharmaceutical Co., Ltd.","INDUSTRY",18,""]