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- Ensaio Clínico NCT07799688
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Chanjuan Deng, MM
- Número de telefone: 0518-82342973
- E-mail: Chanjuan.deng@hengrui.com
Estude backup de contato
- Nome: Jianpeng Su, MS
- Número de telefone: 0518-82342973
- E-mail: jianpeng.su.js18@hengrui.com
Locais de estudo
-
-
Shandong
-
Jinan, Shandong, China, 250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
Investigador principal:
- Mei Gao
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200030
- Shanghai Chest Hospital
-
Investigador principal:
- Xumin Hou
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Cohort 1 (Roll-over participants from HRS-7249-201)
- Able to understand trial procedures, voluntarily participate and provide written informed consent;
- Completed last visit of parent study HRS-7249-201 within 24 weeks prior to screening;
- 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
- Permanently discontinued parent study treatment due to treatment-related adverse events (TRAE);
- Persistent clinically significant adverse events or lab abnormalities unresolved by parent study final visit, judged by investigator to increase risk of continued dosing;
- Unstable or severe hepatic, renal, cardiovascular, neurological, endocrine, hematologic disorders that render participation unacceptable;
- Plan to receive major surgery during study period;
- Planned plasmapheresis during trial;
- Intend to use weight-loss drugs or undergo weight-altering surgery during trial;
- Refuse lifestyle intervention or limit daily alcohol intake below 30 g/day;
- Pregnant or breastfeeding females;
- Fertile women without contraception within 30 days pre-screening; fertile male/female subjects refusing contraception and gamete donation restrictions through follow-up;
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
|
Experimental: Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Injection site reactions
Prazo: 48 weeks
|
48 weeks
|
|
All adverse events (AEs)
Prazo: 72 weeks
|
72 weeks
|
|
Respiratory rate
Prazo: 72 weeks
|
72 weeks
|
|
Pulse rate
Prazo: 72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
Prazo: 72 weeks
|
72 weeks
|
|
Body temperature
Prazo: 72 weeks
|
72 weeks
|
|
Complete Blood Count
Prazo: 72 weeks
|
72 weeks
|
|
Blood chemistry
Prazo: 72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
Prazo: 72 weeks;
|
72 weeks;
|
|
Heart rate
Prazo: 72 weeks;
|
72 weeks;
|
|
PR interval
Prazo: 72 weeks
|
72 weeks
|
|
QRS duration
Prazo: 72 weeks
|
72 weeks
|
|
QT interval
Prazo: 72 weeks
|
72 weeks
|
|
QTc interval
Prazo: 72 weeks
|
72 weeks
|
|
Urinalysis
Prazo: 72 weeks
|
72 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
Prazo: 48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
Prazo: 48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Prazo: 48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
Prazo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
Prazo: 72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
Prazo: 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)
Prazo: 72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
Prazo: 72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Prazo: 72 weeks
|
72 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HRS-7249-203
Plano para dados de participantes individuais (IPD)
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