- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Chanjuan Deng, MM
- 전화번호: 0518-82342973
- 이메일: Chanjuan.deng@hengrui.com
연구 연락처 백업
- 이름: Jianpeng Su, MS
- 전화번호: 0518-82342973
- 이메일: jianpeng.su.js18@hengrui.com
연구 장소
-
-
Shandong
-
Jinan, Shandong, 중국, 250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
수석 연구원:
- Mei Gao
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200030
- Shanghai Chest Hospital
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수석 연구원:
- Xumin Hou
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
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실험적: Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Injection site reactions
기간: 48 weeks
|
48 weeks
|
|
All adverse events (AEs)
기간: 72 weeks
|
72 weeks
|
|
Respiratory rate
기간: 72 weeks
|
72 weeks
|
|
Pulse rate
기간: 72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
기간: 72 weeks
|
72 weeks
|
|
Body temperature
기간: 72 weeks
|
72 weeks
|
|
Complete Blood Count
기간: 72 weeks
|
72 weeks
|
|
Blood chemistry
기간: 72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
기간: 72 weeks;
|
72 weeks;
|
|
Heart rate
기간: 72 weeks;
|
72 weeks;
|
|
PR interval
기간: 72 weeks
|
72 weeks
|
|
QRS duration
기간: 72 weeks
|
72 weeks
|
|
QT interval
기간: 72 weeks
|
72 weeks
|
|
QTc interval
기간: 72 weeks
|
72 weeks
|
|
Urinalysis
기간: 72 weeks
|
72 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
기간: 48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
기간: 48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
기간: 48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
기간: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
기간: 72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
기간: 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)
기간: 72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
기간: 72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
기간: 72 weeks
|
72 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HRS-7249-203
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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