[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654467":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":11,"studyPopulation":11,"armGroups":90,"interventions":101,"overallOfficials":11,"centralContacts":110,"locations":119,"responsibleParty":151,"collaborators":11,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":11,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":11,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":11,"overallStatus":122,"whyStopped":11,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":43,"otherOutcomes":11},[9,13,16,18,20,22,24,26,28,31,33,35,37,39,41],{"measure":10,"description":11,"timeFrame":12},"Injection site reactions",null,"48 weeks",{"measure":14,"description":11,"timeFrame":15},"All adverse events (AEs)","72 weeks",{"measure":17,"description":11,"timeFrame":15},"Respiratory rate",{"measure":19,"description":11,"timeFrame":15},"Pulse rate",{"measure":21,"description":11,"timeFrame":15},"Systolic and diastolic blood pressure",{"measure":23,"description":11,"timeFrame":15},"Body temperature",{"measure":25,"description":11,"timeFrame":15},"Complete Blood Count",{"measure":27,"description":11,"timeFrame":15},"Blood chemistry",{"measure":29,"description":11,"timeFrame":30},"High-sensitivity C-reactive protein (hs-CRP)","72 weeks；",{"measure":32,"description":11,"timeFrame":30},"Heart rate",{"measure":34,"description":11,"timeFrame":15},"PR interval",{"measure":36,"description":11,"timeFrame":15},"QRS duration",{"measure":38,"description":11,"timeFrame":15},"QT interval",{"measure":40,"description":11,"timeFrame":15},"QTc interval",{"measure":42,"description":11,"timeFrame":15},"Urinalysis",[44,46,48,50,52,54,56,58,60,62,64,66,68,70,72,74,76,78,80,82],{"measure":45,"description":11,"timeFrame":12},"Proportion of patients with TG\u003C1.7 mmol\u002FL",{"measure":47,"description":11,"timeFrame":12},"Proportion of patients with TG\u003C2.3 mmol\u002FL",{"measure":49,"description":11,"timeFrame":12},"Proportion of patients with baseline TG≥5.7 mmol\u002FL achieving TG\u003C5.7 mmol\u002FL",{"measure":51,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in TG",{"measure":53,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in APOC3",{"measure":55,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in HDL-C",{"measure":57,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in TC",{"measure":59,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in LDL-C",{"measure":61,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in sdLDL-C",{"measure":63,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in non-HDL-C",{"measure":65,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in ApoB",{"measure":67,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in ApoA1",{"measure":69,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in Lp(a)",{"measure":71,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in VLDL-C",{"measure":73,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in RC",{"measure":75,"description":11,"timeFrame":15},"Percentage change and absolute value change from baseline in HbA1c",{"measure":77,"description":11,"timeFrame":15},"Incidence rate of acute pancreatitis",{"measure":79,"description":11,"timeFrame":15},"Incidence rate of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, or coronary revascularization)",{"measure":81,"description":11,"timeFrame":15},"Plasma Concentration of long-term HRS-7249 treatment",{"measure":83,"description":11,"timeFrame":15},"Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment",{"allocation":85,"interventionModel":86,"interventionModelDescription":11,"primaryPurpose":87,"observationalModel":11,"timePerspective":11,"maskingInfo":88},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":89,"maskingDescription":11,"whoMasked":11},"NONE",[91,97],{"label":92,"type":93,"description":94,"interventionNames":95},"Arm 1","EXPERIMENTAL","HRS-7249 Injection; Low dose, subcutaneous administration",[96],"Drug: HRS-7249 Injection",{"label":98,"type":93,"description":99,"interventionNames":100},"Arm 2","HRS-7249 Injection; High dose, subcutaneous administration",[96],[102,107],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":11},"DRUG","HRS-7249 Injection","Dosing level: Low dose",[92],{"type":103,"name":104,"description":108,"armGroupLabels":109,"otherNames":11},"Dosing level: High dose",[98],[111,116],{"name":112,"role":113,"phone":114,"phoneExt":11,"email":115},"Chanjuan Deng, MM","CONTACT","0518-82342973","Chanjuan.deng@hengrui.com",{"name":117,"role":113,"phone":114,"phoneExt":11,"email":118},"Jianpeng Su, MS","jianpeng.su.js18@hengrui.com",[120,138],{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).","RECRUITING","Jinan","Shandong","250014","China","CN",{"type":129,"coordinates":130},"Point",[131,132],116.99722,36.66833,{"lat":132,"lon":131},[135],{"name":136,"role":137,"phone":11,"phoneExt":11,"email":11},"Mei Gao","PRINCIPAL_INVESTIGATOR",{"facility":139,"status":122,"city":140,"state":141,"zip":142,"country":126,"countryCode":127,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality","200030",{"type":129,"coordinates":144},[145,146],121.45806,31.22222,{"lat":146,"lon":145},[149],{"name":150,"role":137,"phone":11,"phoneExt":11,"email":11},"Xumin Hou",{"type":152,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100654467","phase-2-a-extension-study-to-evaluate-the-safety-and-efficacy-of-hrs-7249-in-patients-with-hypertriglyceridemia-100654467",false,"NCT07799688","A Extension Study to Evaluate the Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia","A Multi-center, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia","Inclusion Criteria:\n\n\\- Cohort 1 (Roll-over participants from HRS-7249-201)\n\n1. Able to understand trial procedures, voluntarily participate and provide written informed consent;\n2. Completed last visit of parent study HRS-7249-201 within 24 weeks prior to screening;\n3. Male or female subjects aged ≥18 and \\\u003C80 years at consent signature. Cohort 2 (Newly enrolled participants)\n\n1\\. Able to understand trial procedures, voluntarily participate and provide written informed consent; 2. Fasting triglyceride ≥2.3 mmol\u002FL at screening; 3. Male or female subjects aged ≥18 and \\\u003C80 years at consent signature.\n\nExclusion Criteria:\n\n\\- Cohort 1 Exclusion\n\n1. Permanently discontinued parent study treatment due to treatment-related adverse events (TRAE);\n2. Persistent clinically significant adverse events or lab abnormalities unresolved by parent study final visit, judged by investigator to increase risk of continued dosing;\n3. Unstable or severe hepatic, renal, cardiovascular, neurological, endocrine, hematologic disorders that render participation unacceptable;\n4. Plan to receive major surgery during study period;\n5. Planned plasmapheresis during trial;\n6. Intend to use weight-loss drugs or undergo weight-altering surgery during trial;\n7. Refuse lifestyle intervention or limit daily alcohol intake below 30 g\u002Fday;\n8. Pregnant or breastfeeding females;\n9. Fertile women without contraception within 30 days pre-screening; fertile male\u002Ffemale subjects refusing contraception and gamete donation restrictions through follow-up;\n10. Any other conditions judged unsuitable by investigator. Cohort 2 Exclusion\n\n1\\. History of acute pancreatitis within 3 months pre-randomization; 2. Plasmapheresis received or planned within 4 weeks pre-randomization; 3. Malignancy diagnosed within past 5 years (except cured non-melanoma skin cancer\u002Fcervical carcinoma in situ); 4. NYHA Class III\u002FIV heart failure at screening\u002Frandomization; 5. Acute coronary syndrome, stroke, TIA, major cardiovascular revascularization within past 3 months; 6. Severe symptomatic arrhythmia within 3 months pre-randomization; 7. Severe trauma\u002Fmajor surgery within 6 months or planned major operation during trial; 8. Severe infection within past 3 months; 9. Nephrotic syndrome, severe liver disease, Cushing syndrome interfering with lipid metabolism; 10. Unstable severe multi-organ systemic diseases; 11. Uncontrolled hypertension (SBP≥160 mmHg or DBP≥100 mmHg); 12. Plan to take weight-loss agents or bariatric surgery within 2 months pre-screening; 13. Type 1 DM, newly diagnosed DM within 12 weeks, or HbA1c ≥8.5%; 14. Current\u002Fhistory hyper\u002Fhypothyroidism; 15. History of substance\u002Falcohol abuse (daily ethanol \\>80 g); 16. Major lifestyle modification within past 4 weeks or refusal of alcohol\u002Flifestyle limits; 17. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² by MDRD formula; 18. ALT\u002FAST ≥2×ULN; 19. Total\u002Fdirect bilirubin ≥1.5×ULN; 20. CK \\>1.5×ULN; 21. Platelet count \\\u003C100×10⁹\u002FL or thrombocytopenia history; 22. Positive HIV\u002FHCV-Ab, or HBsAg positive with HBV-DNA ≥1000 copies\u002FmL; 23. Participated in other interventional drug trials within 3 months pre-screening; 24. Pregnant or lactating women; 25. Fertile subjects without compliant contraception; 26. Any other conditions deemed inappropriate by investigator.","ALL","18 Years","79 Years",{"count":164,"type":165},400,"ESTIMATED","INTERVENTIONAL",[168],"PHASE2","This is a Phase II multi-center, open-label extension (OLE) clinical trial of HRS-7249, a GalNAc-conjugated APOC3-targeted siRNA injection, enrolling two cohorts of participants. Cohort 1 includes subjects who completed parent study HRS-7249-201 within 24 weeks; Cohort 2 newly recruited patients with fasting triglyceride (TG) ≥2.3 mmol\u002FL aged 18-79 years. All participants receive subcutaneous HRS-7249 for a 48-week treatment period followed by a 24-week safety follow-up phase, with two dosing regimens. The primary objective is to assess long-term safety and tolerability of repeated HRS-7249 administration. Secondary objectives include evaluating sustained lipid-lowering effects on TG, APOC3 and other lipid profiles, impacts on glycometabolism, incidence of acute pancreatitis and major adverse cardiovascular events (MACE), long-term pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles, and anti-drug antibody (ADA) dynamics. All safety assessments including vital signs, physical examinations, laboratory tests, 12-lead ECG, injection site reactions and adverse events will be collected throughout the study. Lipid parameters, HbA1c, pancreatitis and cardiovascular events will be monitored to characterize the clinical benefit-risk profile of long-term HRS-7249 therapy in hypertriglyceridemia patients. A total of at least 400 subjects will be enrolled nationwide in China.",[171],"Hyperlipidemia","2026-10-08",{"date":174,"type":175},"2026-10-09","ACTUAL",{"date":177,"type":175},"2026-09-11",{"date":179,"type":165},"2028-10-15",{"name":5,"class":6},2]