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NCT07799688

PHASE2

A Extension Study to Evaluate the Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-center, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-09-30

Completion Date

2028-10-15

Last Updated

2026-09-02

Healthy Volunteers

Conditions

Hyperlipidemia

Interventions

DRUG

HRS-7249 Injection

Dosing level: Low dose

DRUG

HRS-7249 Injection

Dosing level: High dose

Inclusion Criteria: \- Cohort 1 (Roll-over participants from HRS-7249-201) 1. Able to understand trial procedures, voluntarily participate and provide written informed consent; 2. Completed last visit of parent study HRS-7249-201 within 24 weeks prior to screening; 3. Male or female subjects aged ≥18 and \<80 years at consent signature. Cohort 2 (Newly enrolled participants) 1\. Able to understand trial procedures, voluntarily participate and provide written informed consent; 2. Fasting triglyceride ≥2.3 mmol/L at screening; 3. Male or female subjects aged ≥18 and \<80 years at consent signature. Exclusion Criteria: \- Cohort 1 Exclusion 1. Permanently discontinued parent study treatment due to treatment-related adverse events (TRAE); 2. Persistent clinically significant adverse events or lab abnormalities unresolved by parent study final visit, judged by investigator to increase risk of continued dosing; 3. Unstable or severe hepatic, renal, cardiovascular, neurological, endocrine, hematologic disorders that render participation unacceptable; 4. Plan to receive major surgery during study period; 5. Planned plasmapheresis during trial; 6. Intend to use weight-loss drugs or undergo weight-altering surgery during trial; 7. Refuse lifestyle intervention or limit daily alcohol intake below 30 g/day; 8. Pregnant or breastfeeding females; 9. Fertile women without contraception within 30 days pre-screening; fertile male/female subjects refusing contraception and gamete donation restrictions through follow-up; 10. Any other conditions judged unsuitable by investigator. Cohort 2 Exclusion 1\. 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/cervical carcinoma in situ); 4. NYHA Class III/IV heart failure at screening/randomization; 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/major 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/history hyper/hypothyroidism; 15. History of substance/alcohol abuse (daily ethanol \>80 g); 16. Major lifestyle modification within past 4 weeks or refusal of alcohol/lifestyle limits; 17. eGFR \<60 mL/min/1.73m² by MDRD formula; 18. ALT/AST ≥2×ULN; 19. Total/direct bilirubin ≥1.5×ULN; 20. CK \>1.5×ULN; 21. Platelet count \<100×10⁹/L or thrombocytopenia history; 22. Positive HIV/HCV-Ab, or HBsAg positive with HBV-DNA ≥1000 copies/mL; 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.

Locations (2)

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