[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypercholesterolaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypercholesterolaemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,78,105,128,147,181,215,238],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100590964","an-efficacy-and-safety-study-of-akkermansia-muciniphila-akm-lab-01-in-hypercholesterolaemia-100590964",false,"NCT06974266","An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia","A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia","AKM Lab-01","Inclusion Criteria:\n\n1. Aged 35-75 years (inclusive), regardless of gender;\n2. Patients diagnosed with hypercholesterolemia (5.2 mmol\u002FL ≤ TC \\\u003C6.2 mmol\u002FL, or 3.4 mmol\u002FL ≤ LDL-C \\\u003C5.0 mmol\u002FL), with or without hypertriglyceridemia (1.7 mmol\u002FL ≤ TG \\\u003C4.5 mmol\u002FL) or mixed hyperlipidemia (defined as: 1.7 mmol\u002FL ≤ TG \\\u003C4.5 mmol\u002FL and 5.2 mmol\u002FL ≤ TC \\\u003C6.2 mmol\u002FL; or 1.7 mmol\u002FL ≤ TG \\\u003C4.5 mmol\u002FL and 3.4 mmol\u002FL ≤ LDL-C \\\u003C5.0 mmol\u002FL; or 1.7 mmol\u002FL ≤ TG \\\u003C4.5 mmol\u002FL, 5.2 mmol\u002FL ≤ TC \\\u003C6.2 mmol\u002FL and 3.4 mmol\u002FL ≤ LDL-C \\\u003C5.0 mmol\u002FL);\n3. Accompanied by overweight\u002Fobesity (24.0 ≤ BMI ≤40.0 kg\u002Fm²);\n4. Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;\n5. Have controlled of blood lipids solely through lifestyle interventions (diet and exercise) for at least 1 month prior to the screening period;\n6. People must possess communication and cognitive abilities to adhere to long-term medication, and fully understand the nature, significance, potential benefits, inconveniences, and risks of the study before participation;\n7. Fertile patients (male or female) must agree to use at least one medically approved contraceptive method (e.g., intrauterine device \\[IUD\\], oral contraceptives, or condoms) during the trial. Female with childbearing potential must have a negative blood pregnancy test during screening and must not be lactating;\n8. Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule\n\nExclusion Criteria:\n\n1. Have taken any metabolic control medications (e.g., lipid-lowering, blood glucose-regulating, or weight-loss drugs) within the past month or are currently taking such medications.\n2. Patients with secondary hyperlipidemia caused by conditions such as nephrotic syndrome, liver diseases, hypothyroidism, renal failure, etc..\n3. Have severe comorbidities requiring immediate treatment, including uncontrolled diabetes, hypertriglyceridemia, cerebrovascular diseases, etc., as determined by the investigator.\n4. Have severe primary diseases (e.g., hepatic, renal, or hematopoietic system disorders) or psychiatric conditions.\n5. Patients with a family history of genetically inherited metabolic disorders.\n6. Currently taking liver-affecting medications.\n7. Have a history of bariatric surgery.\n8. People with acute or chronic progressive\u002Funstable diseases deemed unsuitable for enrollment by the investigator.\n9. Hepatic or renal dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5×upper limit of normal (ULN); Total bilirubin \\>1.5×ULN; Serum creatinine (Cr) \\>1.5×ULN.\n10. Serum amylase ≥1.5×ULN or other clinically significant laboratory abnormalities per investigator judgment.\n11. Patients with acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) within the past 3 months.\n12. Have a history of gastrointestinal surgery within the past year.\n13. People with allergic constitution or hypersensitivity to the investigational product.\n14. Have used antibiotics, probiotics, or prebiotics within 3 months prior to recruitment.\n15. Excessive alcohol consumption in the past decade (\\>30 g\u002Fday for males; \\>20 g\u002Fday for females).\n16. Pregnant or breastfeeding subjects.\n17. Excluded for other reasons as determined by the investigator.","ALL","35 Years","75 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.",[28],"Hypercholesterolaemia","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2025-06-25",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"Moon (Guangzhou) Biotechnology Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100641269","phase-2-a-study-to-evaluate-the-pharmacodynamics-of-a-combination-of-qcz484-and-inclisiran-in-participants-with-hypertension-and-concomitant-hypercholesterolemia-100641269","NCT07610278","A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia","A Multicenter, Randomized, Double-blind, Factorial Design Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of HDY015 Administered as a Free Combination of QCZ484 and Inclisiran Compared to QCZ484, Inclisiran, and Placebo in Participants With Hypertension and Concomitant Hypercholesterolemia","Inclusion Criteria:\n\n* Males or females aged 18 to 75 years.\n* Diagnosis of primary hypertension.\n* Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening.\n* Systolic blood pressure ≥140 and \\\u003C165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring.\n* Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1.\n\nThe following parameters must be confirmed at Screening Visit 2:\n\n* Fasting serum LDL-C ≥70 mg\u002FdL and \\\u003C190 mg\u002FdL using Friedewald equation.\n* Fasting triglyceride \\\u003C400 mg\u002FdL.\n\nExclusion Criteria:\n\n* Symptomatic orthostatic hypotension.\n* Treatment with certain medications and\u002For unable to comply with prohibited medications requirements.\n\nOther protocol inclusion\u002Fexclusion criteria may apply","18 Years",{"count":51,"type":22},120,[53],"PHASE2","This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.",[28],[57,58,59,60,61,62,63,64,65,66,67],"Hypertension","hypercholesterolemia","siRNA","inclisiran","QCZ484","randomized","double-blind","Phase 2","pharmacodynamics","AGT","PCSK9","2026-06-19",{"date":70,"type":33},"2026-06-23",{"date":72,"type":33},"2026-05-29",{"date":74,"type":22},"2028-01-28",{"name":76,"class":40},"Novartis Pharmaceuticals",26,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":41},"100642965","phase-3-phase-3-clinical-study-evaluating-efficacy-safety-and-tolerability-of-obicetrapib-vs-bempedoic-acid-to-treat-dyslipidemia-in-adults-with-primary-non-familial-hypercholesterolemia-or-mixed-dyslipidemia-at-high-to-very-high-cardiovascular-risk-during-a-treatment-period-of-approximately-84-days-100642965","NCT07614958","Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days","A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk","MEDICI","Inclusion Criteria:\n\n* Are male or female and ≥18 years of age at Screening (Visit 1);\n* Females may be enrolled if all 3 of the following criteria are met:\n\n  1. Are not pregnant;\n  2. Are not breastfeeding; and\n  3. Do not plan to become pregnant during the study.\n* Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;\n* Are on stable maximally tolerated lipid-modifying therapy for at least 8 weeks prior to Screening (Visit 1) as an adjunct to a lipid-lowering diet and lifestyle modifications, defined as a maximum tolerated statin dose, with or without ezetimibe and\u002For a monoclonal PCSK9-targeted therapy for at least 4 stable doses prior to Screening (Visit 1);\n* Have a fasting serum LDL-C at Screening (Visit 1) of ≥70 mg\u002FdL (1.81 mmol\u002FL) and \\\u003C130 mg\u002FdL (3.37 mmol\u002FL);\n* Have fasting TGs \\\u003C500 mg\u002FdL (\\\u003C5.7 mmol\u002FL) at Screening (Visit 1); and\n* Have an eGFR ≥30 mL\u002Fmin\u002F1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).\n\nExclusion Criteria:\n\n* Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction \\\u003C30%;\n* Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);\n* Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and\u002For Hospitalization for unstable angina and\u002For chest pain.\n* Have uncontrolled severe hypertension;\n* Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid Network criteria, Simon Broome, or MedPed;\n* Have active liver disease;\n* Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg\u002FdL (≥15.0 mmol\u002FL) at Screening (Visit 1);\n* Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and\u002For systemic therapy during the 3 years prior to Screening (Visit 1);\n* Have history of full statin intolerance;",{"count":87,"type":22},426,[89],"PHASE3","This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.\n\nThe primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks",[92,28],"Mixed Dyslipidemia",[94,95,28,92],"Bempedoic Acid","Obicetrapib","2026-06-05",{"date":98,"type":33},"2026-06-09",{"date":100,"type":33},"2026-05-06",{"date":102,"type":22},"2027-01",{"name":104,"class":40},"A. Menarini International Licensing S.A.",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100638288","phase-3-a-phase-iii-study-to-assess-the-effect-of-fdc-laroprovstatrosuvastatin-compared-with-laroprovstat-rosuvastatin-and-placebo-on-ldl-c-in-llt-nave-patients-100638288","NCT07619131","A Phase III Study to Assess the Effect of FDC Laroprovstat\u002FRosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.","A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat\u002FRosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age\n* Participants with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low\n* Participants who have not received any LLT in the 3 months prior to screening\n\nExclusion Criteria:\n\n* Asian origin.\n* Statin intolerance\n* Uncontrolled severe hypertension\n* Uncontrolled type 2 diabetes mellitus\n* Inadequately treated hypothyroidism","130 Years",{"count":114,"type":22},600,[89],"This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat\u002Frosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat\u002Frosuvastatin are being developed for the treatment of hypercholesterolaemia.",[28],"NOT_YET_RECRUITING","2026-05-26",{"date":121,"type":33},"2026-06-01",{"date":123,"type":22},"2026-08-17",{"date":125,"type":22},"2027-07-30",{"name":127,"class":40},"AstraZeneca",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":112,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100637946","phase-3-a-phase-iii-study-to-assess-the-effect-of-fdc-laroprovstatrosuvastatin-compared-with-rosuvastatin-on-ldl-c-in-patients-with-hypercholesterolaemia-100637946","NCT07619118","A Phase III Study to Assess the Effect of FDC Laroprovstat\u002FRosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia","A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat\u002FRosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age\n* Participants must be on a stable dose of all background LLTs\n* The stable statin dose should be judged as their maximally tolerated dose\n* Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event\n\nExclusion Criteria:\n\n* Asian origin\n* Uncontrolled severe hypertension\n* Uncontrolled T2DM\n* Inadequately treated hypothyroidism",{"count":136,"type":22},200,[89],"The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat\u002Frosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.",[28],[28],{"date":121,"type":33},{"date":143,"type":22},"2026-09-15",{"date":145,"type":22},"2027-05-28",{"name":127,"class":40},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100637749","an-observational-study-to-evaluate-treatment-patterns-in-high-very-high-and-extreme-cardiovascular-risk-patients-with-hypercholesterolemia-including-familial-hypercholesterolemia-100637749","NCT07606118","An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia","An Observational Longitudinal Multicenter Prospective Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia, Over a 1-Year Follow- Up","TRAP-HC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of hypercholesterolemia (including clinical or genetic FH) OR high\u002Fvery high\u002Fextreme CV risk\n* Baseline visit within enrollment window (six months)\n\nExclusion Criteria:\n\n* Significant secondary dyslipidemia (e.g. hypertriglyceridemia)\n* Treatment changes due to non-hypercholesterolemia conditions",{"count":156,"type":22},2500,"OBSERVATIONAL","TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial hypercholesterolemia (FH), who are at high, very high, or extreme cardiovascular risk. Approximately 2,500 adult patients will be enrolled across up to 15 Italian LIPIGEN network centers and followed for 12 months as part of routine clinical practice.\n\nThe study aims to assess LDL-C goal attainment according to current European guidelines, evaluate changes in lipid profiles over time, and investigate treatment adherence, persistence, and therapeutic modifications in response to clinical needs. Data collected during routine visits will include lipid parameters, cardiovascular history, concomitant therapies, safety outcomes, and patient-reported adherence measures.\n\nBy providing real-world evidence on the management of hypercholesterolemia in high-risk populations, the study seeks to identify current gaps between guideline recommendations and clinical practice and to support optimization of cardiovascular risk reduction strategies.",[28,160,161],"Familial Hypercholesterolaemia","CVD Risk",[163,164,165,166,167,168,169,170,171],"LDL Cholesterol","Lipid-Lowering Therapy","Cardiovascular risk","LDL-C goal attainment","Real-world evidence","Lipid Profil","Adherence to Lipid-Lowering Therapies","Changes in Treatment Regimens","Patient Attitudes and Clinical Practices","2026-05-20",{"date":119,"type":33},{"date":175,"type":22},"2026-06-30",{"date":177,"type":22},"2027-12-31",{"name":179,"class":180},"Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)","OTHER",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":192,"conditions":193,"keywords":203,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100630707","phase-1-a-safety-and-tolerability-trial-evaluating-ctx310-in-participants-with-refractory-dyslipidemias-100630707","NCT07491172","A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias","A Phase 1 Open-label, Multicenter, First-in-human, Ascending Dose Trial Evaluating the Safety and Tolerability of a Lipid Nanoparticle Formulation of CRISPR-Guide RNA-Cas9 Nuclease (CTX310) for In Vivo Editing of the Angiopoietin-like 3 (ANGPTL3) Gene in Participants With Refractory Dyslipidemias","Key Inclusion Criteria:\n\n1. Age of ≥18 and ≤75 years at the time of signing the informed consent.\n2. Able to provide written informed consent.\n3. Participants diagnosed with persistent dyslipidemias defined by TG ≥150 mg\u002FdL - and LDL-C ≥70 mg\u002FdL in participants with ASCVD, or LDL-C ≥70 or 100mg\u002FdL in participants with or without ASCVD respectively, or TG ≥500 mg\u002FdL.\n4. Refractory to the maximal intensity or MTD of standard of care lines of lipid-lowering therapies available through routine clinical care, for at least 12 weeks prior to screening\n5. Female participants must be postmenopausal or surgically sterile.\n6. All male participants and their female partners must agree to the use of an acceptable method of effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n1. Participants with familial chylomicronemia syndrome (FCS). Some exceptions may apply.\n2. Evidence of liver disease, defined as but not limited to:\n\n   LFTS \\>2 × upper limit of normal (ULN), or total bilirubin \\>2 × ULN, or INR \\>1.5 × ULN, or liver stiffness measured by liver elastography\n3. Abnormal or compromised function of kidney, heart, blood or liver.\n4. Acute coronary syndrome event or stroke within 24 weeks prior to Day 1. Acute pancreatitis within 12 weeks prior to Day 1.\n5. Current use or use within 365 days from Day 1 of any hepatocyte-targeted small interfering RNA (except inclisiran).\n6. Positive serology for HIV, hepatitis B or hepatitis C (antibody, surface antigen orNAT). Serology consistent with prior immunization will be eligible for the trial.\n7. Any prior malignancy within the past 5 years, or current malignancy (exceptions for resected or removed basal cell carcinoma, squamous cell carcinoma in situ and carcinoma in situ of the cervix or breast).\n8. Women of childbearing potential.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.\n\nNote: The inclusion and exclusion criteria listed represent the global protocol. Additional or modified eligibility criteria may apply in certain countries in accordance with local regulatory and ethics committee requirements and the approved country-specific protocol.",{"count":189,"type":22},90,[191],"PHASE1","This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.",[194,195,196,197,198,199,200,201,202,28],"Cardiovascular","Metabolic Disease","Dyslipidemias","Lipid Disorder","Hypertriglyceridemia","Heterozygous Familial Hypercholesterolemia (HeFH)","Homozygous Familial Hypercholesterolemia (HoFH)","Severe Hypertriglyceridemia (sHTG)","Mixed Hyperlipemia",[204],"Refractory Dyslipidemias","2026-05-19",{"date":207,"type":33},"2026-05-22",{"date":209,"type":33},"2024-06-21",{"date":211,"type":22},"2028-06",{"name":213,"class":40},"CRISPR Therapeutics AG",18,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":223,"enrollmentInfo":224,"targetDuration":226,"studyType":157,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":41},"100621792","evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-alirocumab-300mg-in-italy-100621792","NCT07375225","Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy","Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry","ALINET","Inclusion Criteria:\n\n\\- Patients under alirocumab 300mg treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years;\n* Patients who refuse to participate and to sign informed consent.","80 Years",{"count":225,"type":22},1500,"3 Years","Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.",[28],"2026-01-21",{"date":231,"type":33},"2026-01-29",{"date":233,"type":33},"2024-12-01",{"date":235,"type":22},"2027-12-01",{"name":237,"class":180},"Federico II University",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},"100554619","phase-4-latam-lowers-ldl-c-100554619","NCT06501443","LATAM LOWERS LDL-C","Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C","Inclusion Criteria:\n\n* Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.\n* Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:\n\n  * Was not in cardiogenic shock.\n  * Did not required invasive hemodynamic, inotropic or vasopressor support.\n* Participants are required to be eligible for receiving inclisiran in accordance to approved local label.\n\n  * Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization.\n\nExclusion Criteria:\n\n* Currently on PCSK9i therapy (within last 3 months)\n* Current participation in another clinical study with another study drug\n* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit\n* Pregnant or nursing (lactating) women\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception","100 Years",{"count":247,"type":22},520,[249],"PHASE4","This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.",[28],[253,58,254,255,256],"PCSK9i","atherosclerotic cardiovascular disease","LDL-cholesterol","Latin America","2025-12-22",{"date":259,"type":33},"2025-12-30",{"date":261,"type":33},"2025-02-11",{"date":263,"type":22},"2026-11-29",{"name":76,"class":40},11]