[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lipoprotein-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lipoprotein-disorder":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,62,86],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100651908","phase-2-study-of-oral-hrs-5346-in-adult-patients-with-elevated-lipoproteina-and-high-risk-of-cardiovascular-events-100651908",false,"NCT07767513","Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events","A Randomized, Double-Blind Phase II Study to Evaluate the Efficacy and Safety of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events","Inclusion Criteria:\n\n1. Understand the specific procedures of the trial, voluntarily participate in this trial, and provide written informed consent;\n2. Aged ≥ 18 years on the day of signing the informed consent form;\n3. Body mass index (BMI) ranging from 18.5 to 40 kg\u002Fm²;\n4. High risk of cardiovascular events at screening;\n5. Lp(a) ≥ 150 nmol\u002FL as measured by the central laboratory during the screening period;\n6. For participants receiving pharmacotherapy per clinical practice, they must have been on a stable treatment regimen for a specified duration prior to screening or randomization and are expected to remain on that regimen through the end of the treatment period;\n7. Participants (including their partners) are willing to use effective contraception from the time of signing the informed consent form until 1 month after the last administration of the study drug; female participants must have a negative serum pregnancy test and must not be breastfeeding;\n8. Willing and able to comply with all protocol requirements, including demonstrating adherence to study procedures prior to randomization.\n\nExclusion Criteria:\n\n1. Any of the following occurring within 3 months prior to screening, or between screening and randomization: major cardiac or non-cardiac surgery, coronary, carotid or peripheral arterial revascularization, stroke or transient ischaemic attack, myocardial infarction or unstable angina, acute limb ischaemia; as well as arrhythmias requiring treatment but uncontrolled; or other events deemed clinically unstable by the Investigator;\n2. Participants with planned or anticipated cardiac, cerebrovascular, or peripheral arterial surgery, coronary revascularization, or other major surgery during the trial period after randomization;\n3. History of haemorrhagic stroke or other major bleeding, or occurrence of haemorrhagic stroke or other major bleeding events between screening visit and randomization visit;\n4. Participants with an indication for anticoagulation but not receiving anticoagulant therapy at screening;\n5. History of malignancy of any organ system within 5 years prior to screening, or newly diagnosed malignancy of any organ system between screening visit and randomization visit, regardless of signs of local recurrence or metastasis;\n6. Prior history of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;\n7. Uncontrolled type 1 or type 2 diabetes within 6 months prior to screening, or HbA1c \\>8.0% at screening (a repeat confirmation is allowed);\n8. History of acute kidney injury within 12 months prior to screening;\n9. Uncontrolled hyperthyroidism or hypothyroidism at screening;\n10. Active infection requiring systemic antiviral or antibacterial medication prior to randomization;\n11. New York Heart Association (NYHA) functional class III-IV heart failure at screening, or the most recently measured left ventricular ejection fraction (LVEF) \\\u003C30%;\n12. At screening or prior to randomization, participants suffering from major diseases that are unstable and inadequately controlled, in the judgment of the Investigator;\n13. Chronic, continuous, or repeated use of systemic glucocorticoids within 3 months prior to screening;\n14. Receipt of lipoprotein apheresis within 3 months prior to screening, or planned lipoprotein apheresis during the study period;\n15. Prior receipt of specific antisense or gene therapy;\n16. Treatment with oligonucleotides or small interfering ribonucleic acid (siRNA) within 12 months prior to screening;\n17. Use of weight-loss medications resulting in significant weight loss, or surgery leading to substantial weight loss within 3 months prior to screening;\n18. Known hypersensitivity to the active ingredient or any excipient of HRS-5346;\n19. Uncontrolled hypertension prior to randomization;\n20. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² at screening or prior to randomization, or participants receiving dialysis;\n21. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) \\> 2 times the upper limit of normal (ULN), or total bilirubin \\>1.5 times ULN at screening or prior to randomization;\n22. Human immunodeficiency virus infection (HIV-Ab positive), hepatitis C virus infection (HCV-RNA positive), Treponema pallidum infection (Treponema pallidum antibody positive), hepatitis B virus infection (HBsAg positive) at screening or prior to randomization;\n23. Creatine kinase (CK) \\> 3 times the upper limit of normal (ULN) prior to randomization;\n24. Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above the upper limit of normal (ULN) during screening;\n25. Significant abnormal laboratory parameters at screening or prior to randomization that render the participant unsuitable for this study, as judged by the Investigator;\n26. History of drug or alcohol abuse or dependence in the recent past (within 1 year);\n27. Pregnant or breastfeeding women;\n28. Participation in any clinical trial of investigational drug or medical device within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening, whichever is longer;\n29. The Investigator judges that the participant has poor adherence or any other factor rendering participation inappropriate, including but not limited to circumstances where trial participation would expose the participant to unacceptable risk or may confound study results.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is designed to evaluate the efficacy and safety of HRS-5346 Tablets in participants with high cardiovascular event risk and elevated Lp(a), and to investigate the appropriate dosage of HRS-5346 Tablets",[26],"Lipoprotein Disorder","NOT_YET_RECRUITING","2026-08-12",{"date":30,"type":31},"2026-08-17","ACTUAL",{"date":33,"type":20},"2026-09",{"date":35,"type":20},"2027-05",{"name":37,"class":38},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100650750","phase-1-phase-i-clinical-study-evaluating-the-relative-bioavailability-of-different-formulations-of-hrs-5346-in-healthy-participants-100650750","NCT07752069","Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants","Inclusion Criteria:\n\n1. Voluntary signing of ICF prior to trial initiation; full understanding of trial content, procedures, and potential AEs; willingness to strictly adhere to the protocol and complete the trial.\n2. Age 18-45 years (inclusive) on ICF signing date; male or female.\n3. Body weight ≥ 50 kg (male) or ≥ 45 kg (female); BMI between 19 and 28 kg\u002Fm² (inclusive).\n4. No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray (or CT), per investigator assessment; QTcF ≤ 450 ms (male) or ≤ 470 ms (female) on 12-lead ECG.\n5. Willingness to use effective contraception (participants and partners) from ICF signing to 2 weeks post-last dose; negative serum pregnancy test and non-lactating status for female participants.\n\nExclusion Criteria:\n\n1. Those with any clinically serious diseases judged by the investigator involving the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or other diseases or medical histories that may interfere with the trial results;\n2. Those with malignant tumors, or a history of malignant tumors within 5 years before screening (except for non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia);\n3. Those who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before screening, or who are still within 5 half-lives of the above drugs at the time of screening (whichever is longer);\n4. Those who plan to take medications other than the trial drug during the trial period;\n5. Those who have participated in any clinical trial of drugs or medical devices within 3 months before screening (participation in a clinical trial is defined as: having given informed consent for a clinical trial and having used the trial drug (including placebo) or trial medical device), and who are still within the follow-up period of a clinical study or within 5 half-lives of the trial drug at the time of screening (whichever is longer);\n6. Those with a suspected history of allergy to the study drug or any component of the study drug, those with allergic constitution, or those with a history of severe drug allergy;\n7. Those with a previous history of difficulty in blood collection or inability to tolerate venipuncture, such as those with needle phobia or blood phobia;\n8. Those with a previous history of gastric or intestinal surgery that, in the investigator's opinion, may affect drug absorption, or those with gastrointestinal diseases that may affect drug absorption;\n9. Those who have had a severe infection, severe trauma, or major surgery within 3 months before screening; or those who plan to undergo surgery during the trial period or within two weeks after its completion;\n10. Those who have donated blood or experienced blood loss of ≥ 200 mL in total within 1 month before screening, or ≥ 400 mL in total within 3 months before screening, or those who have received a blood transfusion within 8 weeks;\n11. Those who have smoked an average of ≥ 5 cigarettes per day within 3 months before screening; those who have consumed an average of more than 15 g of alcohol per day within 1 month before screening (5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, approximately 17 mL of low-alcohol liquor, or 10 mL of high-alcohol liquor), or those who refuse to abstain from smoking, alcohol, and caffeinated foods or beverages during the screening period and the trial period, as well as those with special dietary requirements who cannot adhere to a unified diet;\n12. Those who, from 48 hours before taking the study drug until the end of the study, refuse to discontinue any beverages containing methylxanthines, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juices, refuse to refrain from vigorous exercise, or have other factors that may affect drug absorption, distribution, metabolism, or excretion;\n13. Those with a high-sensitivity C-reactive protein level \\> 1.5 times the upper limit of normal, or prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time (APTT) \\> 1.25 times the upper limit of normal during the screening period;\n14. Those who test positive in the infectious disease screening during the screening period (including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis antibody);\n15. Those who have received a vaccination within 1 month before screening or plan to receive a vaccination during the trial or within 1 month after dosing;\n16. Women who are pregnant or lactating at the screening and baseline visits;\n17. Those who test positive in the alcohol breath test at the baseline visit;\n18. Those with a history of drug abuse or substance abuse; or those who test positive in the urine drug test at the screening and baseline visits;\n19. Staff of the research center or other personnel directly involved in the execution of the protocol;\n20. Other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this trial, such as physiological or psychological diseases or conditions that may increase the risk of the trial, affect the participant's compliance with the protocol, or affect the participant's ability to complete the trial.",true,"45 Years",{"count":49,"type":20},50,[51],"PHASE1","This study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. The experimental process includes three stages: screening period, baseline period, and administration observation period.",[26],"2026-08-04",{"date":56,"type":31},"2026-08-07",{"date":58,"type":20},"2026-08",{"date":60,"type":20},"2026-10",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100618147","phase-2-phase-2-study-of-kylo-11-in-ascvd-patients-with-elevated-lpa-100618147","NCT07327840","Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)","A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of Kylo-11 in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)","Inclusion Criteria:\n\n* Age 18 to 80 years\n* Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)\n* Other inclusion criteria applied per protocol.\n\nExclusion Criteria:\n\n* Have moderate to severe heart failure (New York Heart Association \\[NYHA\\] Functional Classification III or IV during Screening) or last known left ventricular ejection fraction \\\u003C30%\n* Have uncontrolled hypertension (systolic blood pressure \\[SBP\\] ≥160 mmHg or diastolic blood pressure \\[DBP\\] ≥100 mmHg)\n* Have uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization\n* Have had any malignancy within 5 years prior to randomization (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma that has been successfully treated)\n* Other exclusion criteria applied per protocol.","80 Years",{"count":71,"type":20},204,[23],"This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).",[26],"RECRUITING","2026-06-23",{"date":78,"type":31},"2026-06-25",{"date":80,"type":31},"2025-10-29",{"date":82,"type":20},"2028-08-31",{"name":84,"class":38},"Kylonova (Xiamen) Biopharma co., LTD.",59,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100617921","the-effect-of-lipoprotein-a-on-arterial-stiffness-endothelial-function-and-myocardial-deformation-100617921","NCT07324902","The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Myocardial Deformation","The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Left Atrial and Left Ventricular Deformation - An Observational Study.","Lpa_endo","Inclusion Criteria:\n\n* Adults participants 18-75 years old\n* Willing to sign the informed consent and paerticipate in the study\n\nExclusion Criteria:\n\n* History of autoimmune\u002Fautoinflammatory disease,\n* Severe valvular heart disease,\n* severe chronic kidney disease(eGFR\\\u003C60 ml\u002Fmin\u002F1.73 m2),\n* Active Pregnancy\n* Severe hepatic impairment.","75 Years",{"count":96,"type":20},300,"OBSERVATIONAL","1. Introduction Lipoprotein(a), or Lp(a), is a type of lipoprotein that is structurally similar to LDL (low-density lipoprotein) but carries an additional protein called apolipoprotein (a).\n2. Purpose of the Study\n\n   The primary purpose of this study is to investigate the effect of Lp(a) levels on arterial stiffness, endothelial function, and left atrial (LA) and left ventricular (LV) deformation over a 12-month follow-up period.\n\n   Secondarily, the study will investigate:\n   * a) The incidence of major adverse cardiovascular events (MACE), including cardiovascular death, acute myocardial infarction, and acute stroke.\n   * b) The correlation between MACE incidence and parameters of arterial stiffness, endothelial function, and LA\u002FLV deformation.\n   * c) The levels of oxidative load markers.\n3. Materials and Methods This observational study will include adults aged 18-75 years (regardless of gender) who visit the outpatient clinics of the 2nd University Cardiology Clinic at \"Attikon\" General Hospital. All participants will sign a consent form. A full medical history, clinical examination, and blood collection will be performed to determine levels of Total Cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a) at each visit..\n\nParticipants will be divided into three groups:\n\n* Group A: Lp(a) ≥50 mg\u002FdL with Total Cholesterol\\\u003C200 mg\u002Fdl\n* Group B : Lp(a) \\\u003C50 mg\u002FdL. with Total Cholesterol\\>200 mg\u002Fdl\n* Group C (Control): Lp(a) \\\u003C50 mg\u002FdL. with Total Cholesterol\\\u003C200 mg\u002Fdl At each group n ≥ 100 participants are anticipated.\n\nMeasurements at baseline, at 6 and at 12 months:\n\n* Arterial Stiffness: Determination of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP device and 24-hour pulse wave analysis with the Mobil-O-Graph device.\n* Endothelial Function: Measurement of the endothelial glycocalyx thickness of sublingual capillaries using a Sidestream Dark Field (SDF) camera (GlycoCheck). This is expressed through the perfused boundary region (PBR) index.\n* Cardiac Deformation: Use of two-dimensional strain (speckle tracking) to calculate the Global Longitudinal Strain (GLS) of the LV and LA strain.\n* Oxidative Load: Determination of malondialdehyde (MDA) and protein carbonyls (PCs) levels as markers of oxidative stress using spectrophotometric kits.\n\nStatistical Analysis: Comparisons regarding the changes in these markers over 6 and 12 months will be conducted between the three groups.",[26,100,101],"Arterial Stiffness","Endothelial Dysfunction",[103,104,105,106,107],"lipoprotein a","artrial stiffness","endothelial glycocalyx","myocardial deformation","oxidative stress","2026-03-10",{"date":110,"type":31},"2026-03-11",{"date":112,"type":31},"2024-09-25",{"date":114,"type":20},"2027-08-17",{"name":116,"class":117},"University of Athens","OTHER",2]