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Phase 2Recruiting

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

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)
Enrolment
400 planned
Conditions
Hyperlipidemia
Interventions
HRS-7249 Injection; HRS-7249 Injection
Ages
adults, older adults
Registry
NCT07799688

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • Injection site reactions
  • All adverse events (AEs)
  • Respiratory rate
  • Pulse rate

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered