[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-hypertriglyceridemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-hypertriglyceridemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,64,88],{"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},"100645349","phase-3-a-phase-3-trial-of-dr10624-versus-placebo-in-patients-with-severe-hypertriglyceridemia-100645349",false,"NCT07680829","A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia","Inclusion Criteria:\n\n1. Age ≥18 years, male or female; BMI 19.0-45.0 kg\u002Fm², body weight ≥50 kg at screening.\n2. Fasting triglyceride (TG) range 5.65-22.60 mmol\u002FL: single screening lab result meets range, plus average of two separate fasting TG tests (interval \\>1 week) within same range prior to randomization.\n3. Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).\n4. Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.\n5. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Confirmed hereditary lipid disorders (Fredrickson Type 1\u002F3, Apo C-II deficiency).\n2. Significant weight loss or planned weight reduction during study.\n3. Severe chronic liver, renal or advanced cardiac disease.\n4. Uncontrolled diabetes or hypertension with severe complications.\n5. Pancreatitis history or symptomatic gallbladder disease.\n6. Recent major cardiovascular, bone or thyroid disorders.\n7. Severe psychiatric illness or substance abuse history.\n8. Prior GLP-1\u002FGCGR\u002FFGF21 agonists or other investigational drugs within 3 months.\n9. Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.\n10. Pregnant, breastfeeding or hypersensitivity to study treatments.\n11. Investigator's judgment of unsuitability for participation.","ALL","18 Years",{"count":19,"type":20},378,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.",[26],"Severe Hypertriglyceridemia","NOT_YET_RECRUITING","2026-07-01",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":20},"2026-08",{"date":35,"type":20},"2030-10",{"name":37,"class":38},"Zhejiang Doer Biologics Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100583779","phase-3-study-of-plozasiran-in-adults-with-severe-hypertriglyceridemia-at-risk-of-acute-pancreatitis-100583779","NCT06880770","Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis","Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)","SHASTA-5","Inclusion Criteria:\n\n* Males, or nonpregnant (who do not plan to become pregnant) nonlactating females\n* Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg\u002FdL (≥ 10 mmol\u002FL)\n* Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.\n* Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg\u002FdL (≤ 3.37 mmol\u002FL) at Screening\n* Screening hemoglobin A1c (HbA1c) ≤ 9.5%\n* Willing to follow diet counseling and maintain a stable low-fat diet\n* Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)\n\nExclusion Criteria:\n\n* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and\u002For triglycerides within 365 days before Day 1, except inclisiran.\n* Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.\n* AP ≤ 4 weeks prior to Randomization\u002FDay 1\n* Body mass index (BMI) \\> 45 kg\u002Fm\\^2\n* Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)\n* Planned coronary intervention (e.g. stent placement or heart bypass) during the study\n* History of arterial revascularization within 16 weeks of Screening\n* History of acute coronary syndrome event within 24 weeks of Screening\n* Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening\n* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study\n* History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening\n* New York Heart Association Class III-IV heart failure or last known ejection fraction of \\\u003C 30%\n* Current diagnosis of nephrotic syndrome\n* Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2\n* Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5× Upper Limit of Normal (ULN) at Screening\n\nNote: Additional Inclusion\u002FExclusion Criteria may apply per protocol",{"count":49,"type":20},288,[23],"This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.",[26],"RECRUITING","2026-06-25",{"date":56,"type":31},"2026-06-26",{"date":58,"type":31},"2025-04-24",{"date":60,"type":20},"2029-06",{"name":62,"class":38},"Arrowhead Pharmaceuticals",95,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100641263","phase-2-a-study-to-assess-the-safety-tolerability-and-efficacy-of-ion775-100641263","NCT07604974","A Study to Assess the Safety, Tolerability and Efficacy of ION775","A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia","Key Inclusion Criteria:\n\n1. Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg\u002FdL) \\[3.95 millimoles per liter (mmol\u002FL)\\] or with sHTG (fasting TG ≥ 500 mg\u002FdL \\[5.65 mmol\u002FL\\]).\n2. Participants should be on standard of care lipid-lowering medications per local guidelines.\n\nKey Exclusion Criteria:\n\n1. Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening.\n2. Alanine aminotransferase or aspartate aminotransferase \\> 2.0 × upper limit of normal.\n3. Total bilirubin \\> 1.5 upper limit of normal unless due to Gilbert's syndrome.\n4. Estimated GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2.\n\nNote: Other protocol pre-specified inclusion\u002Fexclusion criteria may apply.",{"count":72,"type":20},72,[74],"PHASE2","The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).",[77,26],"Hypertriglyceridemia","2026-06-17",{"date":80,"type":31},"2026-06-18",{"date":82,"type":31},"2026-05-12",{"date":84,"type":20},"2028-03",{"name":86,"class":38},"Ionis Pharmaceuticals, Inc.",16,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100613639","phase-2-a-study-of-solbinsiran-ly3561774-in-participants-with-severe-hypertriglyceridemia-100613639","NCT07269210","A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia","SOLARIS-1","Inclusion Criteria:\n\n* History of fasting triglyceride levels of ≥500 milligrams per deciliter (mg\u002FdL), based on medical history\n* Fasting triglyceride level ≥500 mg\u002FdL at two separate visits during screening (at least 7 days apart)\n* Have a body mass index (BMI) within the range of 18.5 to 45.0 kilograms per square meter (kg\u002Fm2) (inclusive)\n\nExclusion Criteria:\n\n* Have had a major atherosclerotic cardiovascular event within the past 3 months prior to screening\n* Have a known genetically confirmed diagnosis of Familial Chylomicronemia Syndrome\n* Have a history of or planned treatment involving any gene editing or gene therapy modalities, including but not limited to CRISPR-based, viral vector-mediated, or other genetic modification techniques\n* Have a history of chronic alcohol abuse within 3 years prior to screening",{"count":97,"type":20},60,[74],"The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in participants with severe hypertriglyceridemia. Participants will receive two subcutaneous injections.",[26],"2026-04-21",{"date":103,"type":31},"2026-04-22",{"date":105,"type":31},"2025-12-08",{"date":107,"type":20},"2027-08",{"name":109,"class":38},"Eli Lilly and Company",40]