[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-hypercholesterolemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-hypercholesterolemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100623060","phase-2-dnv001-injection-in-patients-with-hypercholesterolemia-100623060",false,"NCT07391722","DNV001 Injection in Patients With Hypercholesterolemia","A Multicentre, Randomized, Double-Blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of DNV001 Injection at Different Dosages in Patients With Primary Hypercholesterolaemia or Mixed Hyperlipidaemia and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Inadequate","DNV001","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be eligible for inclusion in this study:\n\n  1. Male or female, aged ≥18 years at the time of signing the informed consent form;\n  2. Diagnosed with primary hypercholesterolaemia or mixed hyperlipidaemia at screening; have been receiving statin therapy prior to screening; and agree to maintain stable statin therapy (i.e., no change in type or dosage, except for safety reasons) throughout the study;\n  3. Fasting LDL-C levels at both the screening and run-in periods must meet the following criteria, as tested by a local laboratory: For subjects with a documented history of ASCVD, fasting LDL-C must be ≥ 70 mg\u002FdL (1.8 mmol\u002FL). For subjects without a documented history of ASCVD, fasting LDL-C must be ≥ 100 mg\u002FdL (2.6 mmol\u002FL);\n  4. Fasting TG ≤ 4.52 mmol\u002FL (400 mg\u002FdL), as tested by a local laboratory, at both the screening and run-in periods;\n  5. Understand the study procedures and methods, voluntarily agree to participate in this study, be willing to comply with the visit schedule and protocol requirements, and provide written informed consent;\n  6. Be willing to adhere to the lifestyle requirements specified in the study protocol (including diet and physical activity level) during the study;\n  7. Female subjects of childbearing potential (WOCBP) and male subjects who have not undergone vasectomy must agree to use a reliable method of contraception during the study and 6 months after study completion or discontinuation; female subjects of childbearing potential must present negative for blood human chorionic gonadotropin (hCG) pregnancy test result at the screening visit and the baseline visit prior to the first dose; male subjects must not donate sperm during the study and for 6 months after study completion or discontinuation.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will not be enrolled in the study:\n\n  1. Diagnosed with homozygous familial hypercholesterolaemia prior to screening;\n  2. Assessed as having an ultra-high risk for overall ASCVD at screening and have undergone percutaneous coronary intervention within 1 year prior to screening;\n  3. Have other diseases that significantly affect blood lipid levels (such as nephrotic syndrome, severe liver diseases) or have dyslipidemia due to other secondary causes (such as drug-induced dyslipidemia);\n  4. History of allergy to drugs or foods (two or more), or a history of specific allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.), or known allergy to any active ingredient or excipient of the investigational product;\n  5. History of malignancy within the past 5 years (except for cured basal cell carcinoma of the skin, etc.), or currently being evaluated for a potential malignancy;\n  6. Office blood pressure measurement during the screening and run-in periods: systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (a repeat measurement is permitted, which must be completed on the same day, and no pharmacological intervention is allowed before the repeat measurement);\n  7. History of serious cardiovascular or cerebrovascular diseases (such as hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, severe arrhythmia), or severe aortic and\u002For peripheral vascular diseases (such as abdominal aortic aneurysm, lower limb arteriosclerosis obliterans), or presence of indications for surgical intervention within 6 months prior to screening or during the run-in period;\n  8. Underwent major surgery within 6 months prior to screening or during the run-in period, or plan to undergo major surgery during the study period;\n  9. History of New York Heart Association (NYHA) class III-IV heart failure, with a left ventricular ejection fraction (LVEF) \\\u003C 40% at screening or run-in period;\n  10. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation) at screening or run-in period;\n  11. Presence of severe thyroid disease (except for those on stable thyroxine replacement therapy or anti-thyroid drug therapy for at least 6 months prior to screening);\n  12. Meet any of the following conditions in laboratory tests at screening or run-in period:\n\n      * Thyroid stimulating hormone (TSH) \\> 1.5 × upper limit of normal (ULN) or \\\u003C 1.0 × ULN;\n      * Creatine kinase (CK) \\> 3×ULN;\n      * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \\>2×ULN;\n      * Total bilirubin (TBIL): 1.5×ULN.\n  13. QT\u002FQTcF interval prolongation (≥ 450 ms for male subjects or ≥ 470 ms for female subjects) at screening or run-in period;\n  14. Positive result for either human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab); positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus load (HBV-DNA) exceeding the upper limit of the local laboratory reference range; or positive for hepatitis C virus antibody (HCV-Ab) with hepatitis C virus load (HCV-RNA) exceeding the upper limit of the local laboratory reference range;\n  15. Poorly controlled type 1 or type 2 diabetes mellitus during the screening or run-in period, defined as glycosylated hemoglobin (HbA1c) \\> 8.5%; or newly diagnosed type 2 diabetes mellitus within 3 months prior to screening;\n  16. History of drug abuse, including repeated high-dose use of dependence-inducing drugs or substances unrelated to medical purposes, including addictive or habitual drugs that cause physical or psychological dependence;\n  17. History of alcohol abuse, defined as consumption of more than 14 standard units of alcohol per week within the past 6 months (one standard unit equals 14 g of pure alcohol, e.g., 360 mL beer, 45 mL spirits \\[≥ 40% alcohol\\], or 150 mL wine);\n  18. History of blood donation within 3 months prior to screening or during the run-in period or blood loss ≥ 400 mL within 6 months prior to randomization (except blood loss due to menstruation);\n  19. Weight change (gain or loss) of ≥ 10% within 3 months prior to screening;\n  20. Received any medication or health product, other than the investigational product and stable-dose statin background therapy, that affects blood lipid levels within 4 weeks or 5 drug half-lives (whichever is longer) prior to randomization, including but not limited to: other statins (except stable statins), ezetimibe and similar agents (e.g., hybutimibe), fibrates, fish oil, niacin, bile acid sequestrants (e.g., cholestyramine), obesity treatment drugs, soluble fiber supplements, plant sterol-enriched margarines, glucagon like peptide-1 (GLP-1) receptor agonists, traditional Chinese medicines or Chinese patent medicines with lipid-lowering effect;\n  21. Received monoclonal antibody PCSK9 inhibitors within 180 days prior to randomization, or small interfering RNA (siRNA)-based PCSK9 inhibitors (e.g., inclisiran) within 12 months prior to randomization;\n  22. Use of drugs or foods contraindicated with statins prior to screening or randomization, without a discontinuation period of at least 5 drug half-lives, e.g., cyclosporine;\n  23. Received systemic glucocorticoids (e.g., prednisone \\> 15 mg\u002Fd or other equivalent doses), thiazide diuretics, β-blockers, and other medications that may affect blood lipid levels within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening or randomization, except for stable, low-dose use deemed by the investigator not to affect blood lipids;\n  24. Participated in any clinical study and received the investigational drug\u002Fdevice within 3 months prior to screening or 5 half lives (whichever is longer) of the investigational drug, or before randomization, or planning to participate in any other clinical study during the study period;\n  25. Pregnant or lactating women, or women of childbearing potential, male participants who plan to conceive (including sperm and egg donation) during the study period and\u002For who do not agree to use effective contraception;\n  26. Any other conditions that, at the discretion of the investigator, would make the subject unsuitable for participation in this study.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II clinical study to evaluate the effectiveness and safety of different doses of DNV001 injection in patients with primary hypercholesterolemia or mixed dyslipidemia who have not achieved adequate control of low-density lipoprotein cholesterol (LDL-C) despite statin therapy.\n\nThe study will enroll approximately 120 participants and will be conducted at 10-15 centers in China. Participants will be randomly assigned to one of four dose groups (50 mg, 150 mg, 300 mg-1, or 300 mg-2) or placebo, administered as subcutaneous injections. The study includes a 2-week screening period, a 4-week run-in period, a 36-week double-blind treatment period, and a 12-week follow-up period, for a total of up to 54 weeks.\n\nThe main goal is to see how much DNV001 lowers LDL-C levels after 24 weeks of treatment. The study will also look at long-term effectiveness, safety, how the body processes the drug, and whether it causes an immune response.\n\nAll participants will continue taking their stable dose of statin medication throughout the study.",[27],"Primary Hypercholesterolemia",[15,29,30,31,32,33],"PCSK9 inhibitor","LDL-C","Hypercholesterolemia","Mixed dyslipidemia","Randomized controlled trial","NOT_YET_RECRUITING","2026-01-29",{"date":37,"type":38},"2026-02-06","ACTUAL",{"date":40,"type":21},"2026-02-05",{"date":42,"type":21},"2028-12-31",{"name":44,"class":45},"Hangzhou Dinovate Biotech Co., Ltd","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100540290","a-study-to-evaluate-the-efficacy-and-safety-of-fixed-dose-combination-of-pitavastatinezetimib-100540290","NCT06314919","A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin\u002FEzetimib","A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin\u002FEzetimibe Under the Real-World Condition","Inclusion Criteria:\n\n* Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia\n* Those who are judged to need administration of a fixed-dose combination of pitavastatin\u002Fezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe\n\nExclusion Criteria:\n\n* Those who are taking a fixed-dose combination of pitavastatin\u002Fezetimibe at study enrollment\n* Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe\n* Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.","19 Years",{"count":55,"type":21},8606,"OBSERVATIONAL","The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin\u002FEzetimibe under the real-world condition",[27,59],"Mixed Dyslipidemia","RECRUITING","2025-09-10",{"date":63,"type":38},"2025-09-12",{"date":65,"type":38},"2024-03-15",{"date":67,"type":21},"2026-06",{"name":69,"class":45},"Boryung Pharmaceutical Co., Ltd",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100559771","phase-3-a-study-on-efficacy-and-safety-of-hst101-in-chinese-patients-with-hypercholesterolemia-100559771","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",{"count":79,"type":21},210,[81],"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.",[31,84,27,85,86,87,88],"Dyslipidemias","Heterozygous Familial Hypercholesterolemia","Hyperlipidemia; Mixed","Metabolic Disease","ASCVD",[29,90,30],"Lerodalcibep","2025-02-04",{"date":93,"type":38},"2025-02-06",{"date":95,"type":38},"2024-11-16",{"date":97,"type":21},"2026-05",{"name":99,"class":45},"Hasten Biopharmaceutical Co., Ltd.",18,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100573565","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-co-administration-of-ad-2281-and-ad-2282-100573565","NCT06747936","A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282","A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combined Administration of AD-2281 and AD-2282 in Patients with Primary Hypercholesterolemia.","Inclusion Criteria:\n\n* Signed informed consent\n* Patients with Primary Hypercholesterolemia\n* Other inclusions applied\n\nExclusion Criteria:\n\n* Patients with Secondary Hypercholesterolemia\n* Other exclusions applied",{"count":109,"type":21},110,[81],"The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia",[27],"2025-02-02",{"date":91,"type":38},{"date":116,"type":21},"2025-02",{"date":118,"type":21},"2026-12",{"name":120,"class":45},"Addpharma Inc."]