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
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Chanjuan Deng, MM
- 电话号码:0518-82342973
- 邮箱:Chanjuan.deng@hengrui.com
研究联系人备份
- 姓名:Jianpeng Su, MS
- 电话号码:0518-82342973
- 邮箱:jianpeng.su.js18@hengrui.com
学习地点
-
-
Shandong
-
Jinan、Shandong、中国、250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
首席研究员:
- Mei Gao
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- Shanghai Chest Hospital
-
首席研究员:
- Xumin Hou
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
|
实验性的:Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Injection site reactions
大体时间:48 weeks
|
48 weeks
|
|
All adverse events (AEs)
大体时间:72 weeks
|
72 weeks
|
|
Respiratory rate
大体时间:72 weeks
|
72 weeks
|
|
Pulse rate
大体时间:72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
大体时间:72 weeks
|
72 weeks
|
|
Body temperature
大体时间:72 weeks
|
72 weeks
|
|
Complete Blood Count
大体时间:72 weeks
|
72 weeks
|
|
Blood chemistry
大体时间:72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
大体时间:72 weeks;
|
72 weeks;
|
|
Heart rate
大体时间:72 weeks;
|
72 weeks;
|
|
PR interval
大体时间:72 weeks
|
72 weeks
|
|
QRS duration
大体时间:72 weeks
|
72 weeks
|
|
QT interval
大体时间:72 weeks
|
72 weeks
|
|
QTc interval
大体时间:72 weeks
|
72 weeks
|
|
Urinalysis
大体时间:72 weeks
|
72 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
大体时间:48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
大体时间:48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
大体时间:48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
大体时间:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
大体时间:72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
大体时间: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)
大体时间:72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
大体时间:72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
大体时间:72 weeks
|
72 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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