[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-familial-hypercholesterolemia-and-mixed-hyperlipidemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-familial-hypercholesterolemia-and-mixed-hyperlipidemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100629383","phase-3-ibi306-monotherapy-in-non-familial-hypercholesterolemia-and-mixed-hyperlipidemia-100629383",false,"NCT07473960","IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 Monotherapy in Participants With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (CREDIT-5)","Inclusion Criteria:\n\n1. Male or female, ≥18 and ≤75 years of age on the day of signing informed consent.\n2. Fasting LDL-C ≥ 2.6 mmol\u002FL and \\\u003C 4.9 mmol\u002FL measured in a local laboratory at screening and randomization.\n3. Fasting triglyceride (TG) ≤ 5.64 mmol\u002FL measured in a local laboratory at screening and randomization.\n4. According to the 2023 Chinese Guidelines for the Management of Blood Lipids, the 10-year risk of atherosclerotic cardiovascular disease is assessed as low or moderate (\\\u003C 10%).\n5. Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1\\. History of any of the following medical or treatment conditions:\n\n1. Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.\n2. Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc.\n3. Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.\n4. History of acute or chronic heart failure with New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction \\\u003C 40% within 3 months prior to screening.\n5. Previous diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, or supraventricular tachycardia poorly controlled by medication, etc.\n6. Poorly controlled hypertension, defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or randomization.\n7. Previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, and other diseases that significantly affect blood lipid levels.\n8. History of type 1 diabetes mellitus, or type 2 diabetes mellitus with one of the following: (1) glycosylated hemoglobin (HbA1c) ≥ 8.5% at screening; (2) severe hypoglycemia within 6 months prior to screening; (3) insulin injection ≥ 2 times per day prior to screening.\n9. History of malignancy within 5 years prior to screening.\n10. Treatment with a PCSK9 monoclonal antibody within 6 months prior to screening or treatment with inclisiran prior to screening.\n11. Participation in a clinical study of any medical device or other drug within 3 months prior to screening (except for screening failure), or less than 5 half-lives from the most recent dose of the investigational drug at screening.\n12. Treatment with systemic cyclosporine within 3 months prior to screening.\n13. Long-term continuous (≥ 7 days) or multiple (≥ 3 times) systemic glucocorticoid therapy within 3 months prior to screening (except for topical, intraocular, intranasal, inhaled, or intra-articular injection).\n14. Treatment with weight-loss drugs or bariatric surgery within 3 months prior to screening.\n15. History of drug or alcohol abuse prior to screening. Average weekly alcohol intake: more than 21 units for males and more than 14 units for females (1 unit = 360 mL of beer, or 150 mL of red wine, or 45 mL of distilled spirits\u002Fwhite wine).\n\n2\\. Paricipants whose laboratory test parameters meet any of the following criteria at screening or randomization:\n\n1. Estimated glomerular filtration rate ( eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m 2 using the MDRD formula.\n2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN), or total bilirubin \\> 1.5 × ULN.\n3. Creatine kinase (CK) \\> 3 × ULN.\n4. Hypothyroidism or hyperthyroidism, defined as thyroid-stimulating hormone (TSH) below the lower limit of normal or exceeding 1.5 times the ULN, respectively.\n5. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) and HBV DNA copy number ≥ 1.0 × 10 3 \u002FmL, or positive for hepatitis C antibody ( except for those who have received complete anti-hepatitis C treatment and whose HCV RNA is below the lower limit of detection ).\n6. Positive for human immunodeficiency virus (HIV) antibodies or syphilis-specific antibodies.\n\n3\\. Female participants of childbearing potential who did not use contraception within 4 weeks prior to screening, or male or female participants who did not agree to use contraception as specified in this protocol throughout the study and for 15 weeks after the last treatment.\n\n4\\. Female participants who are pregnant or lactating. 5. The investigator believes that the subject has poor compliance, or there are factors that may bring unacceptable safety risks or affect the study results.","ALL","18 Years","75 Years",{"count":20,"type":21},198,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed hyperlipidemia. Approximately 198 participants were planned to be enrolled in the study. The entire study period includes a screening period of no more than 2 weeks, a run-in period of 4 weeks, a double-blind treatment period of 12 weeks, and a safety follow-up period after the last treatment. Participants were required to maintain a stable and healthy lifestyle throughout the trial.",[27],"Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia","RECRUITING","2026-04-13",{"date":31,"type":32},"2026-04-14","ACTUAL",{"date":34,"type":32},"2026-04-01",{"date":36,"type":21},"2027-02-28",{"name":38,"class":39},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100625335","phase-3-a-study-to-evaluate-the-safety-efficacy-of-syh2053-as-monotherapy-in-chinese-participants-with-non-familial-hypercholesterolemia-or-mixed-hyperlipidemia-100625335","NCT07421297","A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia","A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection as Monotherapy in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia","Inclusion Criteria:\n\n1. 、Age ≥18 years (inclusive);\n2. 、Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):① Low risk: LDL-C ≥130 mg\u002FdL（3.4 mmol\u002FL）and LDL-C\\\u003C188 mg\u002FdL（4.9 mmol\u002FL）; ②Moderate risk: LDL-C ≥ 100 mg\u002FdL (2.6 mmol\u002FL) and LDL-C\\\u003C188 mg\u002FdL（4.9 mmol\u002FL）; 3、At screening (based on local laboratory results), Fasting serum Triglyceride (TG)\\\u003C500 mg\u002FdL（5.6 mmol\u002FL） 4、Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.\n\nExclusion Criteria:\n\n1. Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；\n2. A documented history of established atherosclerotic cardiovascular disease (ASCVD), defined as a history of: acute coronary syndrome (myocardial infarction or unstable angina), chronic coronary syndrome, or prior coronary revascularization (e.g., PCI or CABG); ischemic stroke or transient ischemic attack (TIA); or significant peripheral artery disease (PAD). PAD includes conditions such as chronic limb-threatening ischemia, acute limb ischemia, or atherosclerotic disease in other major arteries (e.g., carotid, vertebral, subclavian, renal, or mesenteric arteries)；\n3. Treatment with short-acting lipid-lowering therapies (e.g., statins, fibrates, bempedoic acid, ezetimibe, bile acid sequestrants, niacin, omega-3 fatty acids) or any preparation of unknown composition with lipid-lowering intent (including over-the-counter, traditional, or herbal medicines) within 90 days prior to screening; or treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with inclisiran or any other RNA-based lipid-lowering therapy (e.g., siRNA, antisense oligonucleotide) within the past 2 years before screening;\n4. History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;\n5. At screening, Systolic blood pressure (SBP) \\> 160 mmHg or diastolic blood pressure (DBP) \\> 100 mmHg（either in untreated patients or in those on stable medical therapy） ;\n6. History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization;\n7. At screening, eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²（as calculated by the CKD-EPI equation）;\n8. At screening, Creatine Kinase (CK) \\> 3 × ULN ;\n9. At screening, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN or Total Bilirubin (TBIL), \\> 1.5 × ULN （unless attributable to Gilbert's syndrome）;\n10. At screening, prolonged QT\u002FQTcF interval at Screening Period or prior to Randomization (QTcF \\> 450 ms for males, \\> 470 ms for females)\n11. Positive result for any one of hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, syphilis antibody, or Human Immunodeficiency Virus (HIV) antibody;\n12. At screening, HbA1c \\> 8.0% at screening Period or prior to Randomization; or Type 1 diabetes , gestational diabetes ;\n13. History of drug abuse within 5 years, including the recurrent use of dependence-producing drugs or substances unrelated to medical purposes in large quantities, including addictive and habituating drugs that cause physical and psychological dependence;\n14. History of alcohol abuse within 1 year (defined as consuming more than 14 units of alcohol per week \\[1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content\\]);\n15. Participation in any other clinical trial involving the administration of an investigational drug within 3 months prior to Screening or within 5 half-lives of the other investigational drug (whichever is longer), or plans to participate in any other clinical trial during the study period;\n16. Any condition that, in the Investigator's opinion, may interfere with the conduct of the study, including but not limited to: a. presence of any disease within 6 months prior to Screening through the study period that may interfere with study results; b. any other reason that would prevent the subject from completing the study or that makes them inappropriate for inclusion;",{"count":49,"type":21},760,[24],"The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia .\n\nThis trial plans to enroll 760 Participants.",[53],"Non-familial Hypercholesterolemia and Mixed Hyperlipidemia",{"date":55,"type":32},"2026-04-07",{"date":57,"type":32},"2026-02-28",{"date":59,"type":21},"2028-01-31",{"name":61,"class":39},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.",2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":40},"100625334","phase-3-a-study-to-evaluate-the-safety-efficacy-of-syh2053-in-chinese-participants-with-non-familial-hypercholesterolemia-and-mixed-hyperlipidemia-on-a-background-of-lipid-lowering-therapy-100625334","NCT07421284","A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy","A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia on a Background of Lipid-lowering Therapy","Inclusion Criteria:\n\n1. Age of 18 - 75 years (inclusive);\n2. Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained stable dose of lipid-lowering therapy (statin with other lipid-lowering therapy) ≥4 weeks;\n3. Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):\n\nWith a history of ASCVD:\n\n1. Very high risk: 55 mg\u002FdL (1.4 mmol\u002FL) ≤ LDL-C \\\u003C 188 mg\u002FdL (4.9 mmol\u002FL);\n2. Extremely high risk: LDL-C ≥ 70 mg\u002FdL (1.8 mmol\u002FL);\n\n   Without a history of ASCVD:\n3. Moderate to high risk: LDL-C ≥ 100 mg\u002FdL (2.6 mmol\u002FL);\n4. Low risk: LDL-C ≥ 130 mg\u002FdL (3.4 mmol\u002FL); 4.Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.\n\nExclusion Criteria:\n\n1. Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；\n2. Treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with incisiran or any other RNA-based lipid-lowering therapy within the past 2 years before screening;\n3. History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;\n4. Systolic blood pressure (SBP) \\> 180 mmHg or diastolic blood pressure (DBP) \\> 110 mmHg during the Screening Period or prior to Randomization;\n5. History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization, or LVEF \\\u003C 40% within 180 days before screening;\n6. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² during the Screening Period or prior to Randomization;\n7. Creatine Kinase (CK) \\> 3 × ULN at Screening Period;\n8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN or Total Bilirubin (TBIL), \\> 1.5 × ULN at Screening Period or prior to Randomization;\n9. Prolonged QT\u002FQTcF interval at Screening Period or prior to Randomization (QTcF \\> 450 ms for males, \\> 470 ms for females)\n10. Positive result for any one of hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, syphilis antibody, or Human Immunodeficiency Virus (HIV) antibody;\n11. HbA1c \\> 8.0% at screening Period or prior to Randomization; or Type 1 diabetes , gestational diabetes ;\n12. History of drug abuse within 5 years, including the recurrent use of dependence-producing drugs or substances unrelated to medical purposes in large quantities, including addictive and habituating drugs that cause physical and psychological dependence;\n13. History of alcohol abuse within 1 year (defined as consuming more than 14 units of alcohol per week \\[1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content\\]);\n14. Participation in any other clinical trial involving the administration of an investigational drug within 3 months prior to Screening or within 5 half-lives of the other investigational drug (whichever is longer), or plans to participate in any other clinical trial during the study period;\n15. Any condition that, in the Investigator's opinion, may interfere with the conduct of the study, including but not limited to: a. presence of any disease within 6 months prior to Screening through the study period that may interfere with study results; b. any other reason that would prevent the subject from completing the study or that makes them inappropriate for inclusion;",{"count":71,"type":21},900,[24],"The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.\n\nThis trial plans to enroll 900 Participants.",[53],"NOT_YET_RECRUITING","2026-02-12",{"date":78,"type":32},"2026-02-19",{"date":80,"type":21},"2026-03-31",{"date":59,"type":21},{"name":61,"class":39}]