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
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
連絡先と場所
研究連絡先
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
-
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
-
Shanghai、Shanghai Municipality、中国、200030
- Shanghai Chest Hospital
-
主任研究者:
- Xumin Hou
-
-
参加基準
適格基準
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)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・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
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
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)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- HRS-7249-203
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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