Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

28. august 2026 opdateret af: Fujian Shengdi Pharmaceutical Co., Ltd.

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Shandong
      • Jinan, Shandong, Kina, 250014
        • The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
        • Ledende efterforsker:
          • Mei Gao
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Shanghai Chest Hospital
        • Ledende efterforsker:
          • Xumin Hou

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
Dosing level: Low dose
Dosing level: High dose
Eksperimentel: Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
Dosing level: Low dose
Dosing level: High dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Injection site reactions
Tidsramme: 48 weeks
48 weeks
All adverse events (AEs)
Tidsramme: 72 weeks
72 weeks
Respiratory rate
Tidsramme: 72 weeks
72 weeks
Pulse rate
Tidsramme: 72 weeks
72 weeks
Systolic and diastolic blood pressure
Tidsramme: 72 weeks
72 weeks
Body temperature
Tidsramme: 72 weeks
72 weeks
Complete Blood Count
Tidsramme: 72 weeks
72 weeks
Blood chemistry
Tidsramme: 72 weeks
72 weeks
High-sensitivity C-reactive protein (hs-CRP)
Tidsramme: 72 weeks;
72 weeks;
Heart rate
Tidsramme: 72 weeks;
72 weeks;
PR interval
Tidsramme: 72 weeks
72 weeks
QRS duration
Tidsramme: 72 weeks
72 weeks
QT interval
Tidsramme: 72 weeks
72 weeks
QTc interval
Tidsramme: 72 weeks
72 weeks
Urinalysis
Tidsramme: 72 weeks
72 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of patients with TG<1.7 mmol/L
Tidsramme: 48 weeks
48 weeks
Proportion of patients with TG<2.3 mmol/L
Tidsramme: 48 weeks
48 weeks
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Tidsramme: 48 weeks
48 weeks
Percentage change and absolute value change from baseline in TG
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in APOC3
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in HDL-C
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in TC
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in LDL-C
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in sdLDL-C
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in non-HDL-C
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in ApoB
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in ApoA1
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in Lp(a)
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in VLDL-C
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in RC
Tidsramme: 72 weeks
72 weeks
Percentage change and absolute value change from baseline in HbA1c
Tidsramme: 72 weeks
72 weeks
Incidence rate of acute pancreatitis
Tidsramme: 72 weeks
72 weeks
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)
Tidsramme: 72 weeks
72 weeks
Plasma Concentration of long-term HRS-7249 treatment
Tidsramme: 72 weeks
72 weeks
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Tidsramme: 72 weeks
72 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

15. oktober 2028

Studieafslutning (Anslået)

15. oktober 2028

Datoer for studieregistrering

Først indsendt

21. august 2026

Først indsendt, der opfyldte QC-kriterier

28. august 2026

Først opslået (Faktiske)

2. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HRS-7249-203

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner