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
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Chanjuan Deng, MM
- 電話番号:0518-82342973
- メール:Chanjuan.deng@hengrui.com
研究連絡先のバックアップ
- 名前:Jianpeng Su, MS
- 電話番号:0518-82342973
- メール:jianpeng.su.js18@hengrui.com
研究場所
-
-
Shandong
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Jinan、Shandong、中国、250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
主任研究者:
- Mei Gao
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- Shanghai Chest Hospital
-
主任研究者:
- Xumin Hou
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
|
実験的:Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Injection site reactions
時間枠:48 weeks
|
48 weeks
|
|
All adverse events (AEs)
時間枠:72 weeks
|
72 weeks
|
|
Respiratory rate
時間枠:72 weeks
|
72 weeks
|
|
Pulse rate
時間枠:72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
時間枠:72 weeks
|
72 weeks
|
|
Body temperature
時間枠:72 weeks
|
72 weeks
|
|
Complete Blood Count
時間枠:72 weeks
|
72 weeks
|
|
Blood chemistry
時間枠:72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
時間枠:72 weeks;
|
72 weeks;
|
|
Heart rate
時間枠:72 weeks;
|
72 weeks;
|
|
PR interval
時間枠:72 weeks
|
72 weeks
|
|
QRS duration
時間枠:72 weeks
|
72 weeks
|
|
QT interval
時間枠:72 weeks
|
72 weeks
|
|
QTc interval
時間枠:72 weeks
|
72 weeks
|
|
Urinalysis
時間枠:72 weeks
|
72 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
時間枠:48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
時間枠:48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
時間枠:48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
時間枠:72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
時間枠:72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
時間枠: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)
時間枠:72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
時間枠:72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
時間枠:72 weeks
|
72 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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