HRS-7249 extension study for people with high triglycerides

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, multi-center, open-label extension study evaluating long-term safety and tolerability of HRS-7249, a GalNAc-conjugated APOC3-targeted siRNA, administered subcutaneously over 48 weeks with a 24-week safety follow-up. Cohort 1 includes participants who completed the parent study within 24 weeks, and Cohort 2 enrolls new participants with fasting triglycerides ≥2.3 mmol/L aged 18–79. Secondary objectives examine sustained lipid lowering (TG, APOC3, other lipids), effects on glycometabolism, incidence of pancreatitis and major adverse cardiovascular events, PK/PD profiles, and anti-drug antibodies. Safety assessments include vital signs and physical exams throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
  Jinan, Shandong, China Recruiting
• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chanjuan Deng, MM
• Email: Chanjuan.deng@hengrui.com
• Phone: 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.