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- Ensayo 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chanjuan Deng, MM
- Número de teléfono: 0518-82342973
- Correo electrónico: Chanjuan.deng@hengrui.com
Copia de seguridad de contactos de estudio
- Nombre: Jianpeng Su, MS
- Número de teléfono: 0518-82342973
- Correo electrónico: jianpeng.su.js18@hengrui.com
Ubicaciones de estudio
-
-
Shandong
-
Jinan, Shandong, Porcelana, 250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
Investigador principal:
- Mei Gao
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Shanghai Chest Hospital
-
Investigador principal:
- Xumin Hou
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Injection site reactions
Periodo de tiempo: 48 weeks
|
48 weeks
|
|
All adverse events (AEs)
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Respiratory rate
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Pulse rate
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Body temperature
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Complete Blood Count
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Blood chemistry
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
Periodo de tiempo: 72 weeks;
|
72 weeks;
|
|
Heart rate
Periodo de tiempo: 72 weeks;
|
72 weeks;
|
|
PR interval
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
QRS duration
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
QT interval
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
QTc interval
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Urinalysis
Periodo de tiempo: 72 weeks
|
72 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
Periodo de tiempo: 48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
Periodo de tiempo: 48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Periodo de tiempo: 48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
Periodo de tiempo: 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)
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
Periodo de tiempo: 72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Periodo de tiempo: 72 weeks
|
72 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HRS-7249-203
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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