A Extension Study to Evaluate the Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. • ClinicalTrials.gov ID: NCT07799688
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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/L 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/pharmacodynamic (PK/PD) 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.
Interventions
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HRS-7249 Injection
(Drug)
Dosing level: Low dose
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HRS-7249 Injection
(Drug)
Dosing level: High dose
Eligibility criteria
Conditions
Locations
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province). — Jinan, Shandong, China
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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